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Overview-snap.png differ diff --git a/screenshot-test/__baseline_snapshots__/User Details Page-snap.png b/screenshot-test/__baseline_snapshots__/User Details Page-snap.png index 814af6583..332f22de1 100644 Binary files a/screenshot-test/__baseline_snapshots__/User Details Page-snap.png and b/screenshot-test/__baseline_snapshots__/User Details Page-snap.png differ diff --git a/screenshot-test/__baseline_snapshots__/Users Infomation Page-snap.png b/screenshot-test/__baseline_snapshots__/Users Infomation Page-snap.png index c837fdd00..8d2ae69f6 100644 Binary files a/screenshot-test/__baseline_snapshots__/Users Infomation Page-snap.png and b/screenshot-test/__baseline_snapshots__/Users Infomation Page-snap.png differ diff --git a/src/main/webapp/app/components/Header.tsx b/src/main/webapp/app/components/Header.tsx index 92b0a8a25..ff6f2d8d1 100644 --- a/src/main/webapp/app/components/Header.tsx +++ b/src/main/webapp/app/components/Header.tsx @@ -79,6 +79,7 @@ class Header extends React.Component { }, { title: 'Actionable Genes', link: PAGE_ROUTE.ACTIONABLE_GENE }, { title: 'Oncology Therapies', link: PAGE_ROUTE.ONCOLOGY_TX }, + { title: 'CDx', link: PAGE_ROUTE.CDX }, { title: 'Cancer Genes', link: PAGE_ROUTE.CANCER_GENES }, { title: 'API / License', diff --git a/src/main/webapp/app/components/oncokbTable/OncoKBTable.tsx b/src/main/webapp/app/components/oncokbTable/OncoKBTable.tsx index 30383f17e..db9a37ff0 100644 --- a/src/main/webapp/app/components/oncokbTable/OncoKBTable.tsx +++ b/src/main/webapp/app/components/oncokbTable/OncoKBTable.tsx @@ -2,6 +2,7 @@ import React from 'react'; import ReactTable, { Column, TableProps } from 'react-table'; import { observer } from 'mobx-react'; import { observable, computed } from 'mobx'; +import classNames from 'classnames'; export type SearchColumn = Column & { onFilter?: (data: T, keyword: string) => boolean; @@ -87,9 +88,12 @@ export default class OncoKBTable extends React.Component< diff --git a/src/main/webapp/app/config/constants.tsx b/src/main/webapp/app/config/constants.tsx index 6fbf3472c..dcdc00c85 100644 --- a/src/main/webapp/app/config/constants.tsx +++ b/src/main/webapp/app/config/constants.tsx @@ -544,6 +544,7 @@ export enum PAGE_ROUTE { ACTIONABLE_GENE = '/actionable-genes', PO_TX = '/precision-oncology-therapies', ONCOLOGY_TX = '/oncology-therapies', + CDX = '/companion-diagnostic-devices', GENE_HEADER = '/gene', GENE = '/gene/:hugoSymbol', ALTERATION = '/gene/:hugoSymbol/:alteration', @@ -798,6 +799,7 @@ export type DataRelease = { }; export const DATA_RELEASES: DataRelease[] = [ + { date: '05012024', version: 'v4.16' }, { date: '03212024', version: 'v4.15' }, { date: '02082024', version: 'v4.14' }, { date: '12212023', version: 'v4.13' }, @@ -918,3 +920,10 @@ export const DEFAULT_REFERENCE_GENOME = REFERENCE_GENOME.GRCh37; export const DEFAULT_FEEDBACK_ANNOTATION: Feedback = { type: FeedbackType.ANNOTATION, }; + +export const FDA_SUBMISSION_URL_SUFFIX = { + PMA: 'cfpma/pma.cfm', + PMN: 'cfpmn/pmn.cfm', + HDE: 'cfhde/hde.cfm', + DEN: 'cfpmn/denovo.cfm', +}; diff --git a/src/main/webapp/app/pages/companionDiagnosticDevicesPage/companionDiagnosticDevicePage.tsx b/src/main/webapp/app/pages/companionDiagnosticDevicesPage/companionDiagnosticDevicePage.tsx new file mode 100644 index 000000000..06a36b0fe --- /dev/null +++ b/src/main/webapp/app/pages/companionDiagnosticDevicesPage/companionDiagnosticDevicePage.tsx @@ -0,0 +1,651 @@ +import OncoKBTable, { + SearchColumn, +} from 'app/components/oncokbTable/OncoKBTable'; +import Select from 'react-select'; +import companionDiagnosticDevices from 'content/files/companionDiagnosticDevices/companion_diagnostic_devices.json'; +import { + COMPONENT_PADDING, + LG_TABLE_FIXED_HEIGHT, + ONCOKB_TM, +} from 'app/config/constants'; +import { filterByKeyword, getAllTumorTypesName } from 'app/shared/utils/Utils'; +import React, { useEffect, useState, useMemo } from 'react'; +import { Button, Col, Row } from 'react-bootstrap'; +import _ from 'lodash'; +import classnames from 'classnames'; +import { Input } from 'reactstrap'; +import WithSeparator from 'react-with-separator'; +import { AlterationPageLink, GenePageLink } from 'app/shared/utils/UrlUtils'; +import { pluralize } from 'cbioportal-frontend-commons'; +import { downloadFile } from 'app/shared/utils/FileUtils'; +import CancerTypeSelect from 'app/shared/dropdown/CancerTypeSelect'; +import { + sortByStringArray, + tumorTypeSortMethod, +} from 'app/shared/utils/ReactTableUtils'; +import privateClient from 'app/shared/api/oncokbPrivateClientInstance'; +import { TumorType } from 'app/shared/api/generated/OncoKbPrivateAPI'; +import { FdaSubmissionLink } from 'app/shared/links/FdaSubmissionLink'; +import { Linkout } from 'app/shared/links/Linkout'; +import InfoIcon from 'app/shared/icons/InfoIcon'; + +export interface ICompanionDiagnosticDevice { + name: string; + manufacturer: string; + platformType?: string | null; + biomarkerAssociation: IBiomarkerAssociation; + specimenTypes?: string[]; +} + +export interface IFdaSubmission { + id: number; + number: string; + supplementNumber: string; + deviceName: string; + genericName: string; + dateReceived: string; + decisionDate: string; + description: string; + curated: boolean; + genetic: boolean; + note: string; + associations: any[]; + type: IFdaSubmissionType; +} + +interface IFdaSubmissionType { + id: number; + type: string; + name: string; + shortName: string; + description: string; +} + +interface IBiomarkerAssociation { + id: number; + gene: string; + alterations: string[]; + drugs: string; + cancerTypes: ICancerType[]; + fdaSubmissions: any[]; +} + +interface ICancerType { + code: string; + color: string; + id: number; + level: number; + mainType: string; + subtype: string; + tissue: string; + tumorForm: 'SOLID' | 'LIQUID' | 'MIXED'; +} + +type SelectOption = { + value: string; + label: string; +}; + +const referenceColumnInfo = ( +
+ Premarket Approval (PMA) / 510(k) or 513(f2) Premarket Notification / + Humanitarian Device Exemption (HDE) (Approval/Clearance or Grant Date) +
+); + +const parseCDx = () => { + const parsedCompanionDiagnosticDevices: ICompanionDiagnosticDevice[] = []; + for (const cdx of companionDiagnosticDevices) { + const associationList: any[] = []; + for (const fdaSubmission of cdx.fdaSubmissions) { + const { associations, ...restFdaSubmission } = fdaSubmission; + for (const association of associations) { + const index = associationList.findIndex( + assoc => assoc.id === association.id + ); + if (index > -1) { + associationList[index].fdaSubmissions.push({ ...restFdaSubmission }); + } else { + associationList.push({ + ...association, + fdaSubmissions: [{ ...restFdaSubmission }], + }); + } + } + } + + _.flatten( + associationList.map((assoc: any) => { + return _.uniq( + assoc.alterations.reduce( + (acc: any[], alt: any) => + acc.concat(alt.genes.map((gene: any) => gene.hugoSymbol)), + [] + ) + ).map((gene: any) => ({ + gene, + alterations: _.chain(assoc.alterations) + .map((a: any) => a.name) + .uniq() + .sort() + .value(), + drugs: assoc.treatments + .map((treatment: any) => + treatment.drugs.map((drug: any) => drug.name).join(' + ') + ) + .join(', '), + cancerTypes: assoc.associationCancerTypes.reduce( + (ctAcc: any[], act: any) => { + ctAcc.push(act.cancerType); + return ctAcc; + }, + [] + ), + fdaSubmissions: assoc.fdaSubmissions, + })); + }) + ).forEach((assoc: IBiomarkerAssociation) => { + parsedCompanionDiagnosticDevices.push({ + name: cdx.name, + manufacturer: cdx.manufacturer, + platformType: cdx.platformType, + specimenTypes: _.chain(cdx.specimenTypes) + .map((st: any) => st.name) + .sort() + .value(), + biomarkerAssociation: assoc, + }); + }); + } + return parsedCompanionDiagnosticDevices; +}; +const parsedCDx: ICompanionDiagnosticDevice[] = parseCDx(); + +const downloadCDx = () => { + const seperator = '\t'; + const headers = [ + 'Gene', + 'Alteration(s)', + 'Cancer Type', + 'Drug(s)', + 'Companion Diagnostic Device', + 'Specimen Types(s)', + 'Platform Type', + ].join(seperator); + const rows = parsedCDx.map(cdx => { + const row = []; + row.push(cdx.biomarkerAssociation.gene); + row.push(cdx.biomarkerAssociation.alterations.join(', ')); + row.push(getAllTumorTypesName(cdx.biomarkerAssociation.cancerTypes)); + row.push(cdx.biomarkerAssociation.drugs); + row.push(`${cdx.name} (${cdx.manufacturer})`); + row.push(cdx.specimenTypes?.join(', ') || ''); + row.push(cdx.platformType || ''); + return row.join(seperator); + }); + + downloadFile( + 'companion_diagnostic_devices.tsv', + [headers, ...rows].join('\r\n') + ); +}; + +const CompanionDiagnosticDevicePage: React.FunctionComponent<{}> = () => { + const [hasFilter, setHasFilter] = useState(false); + const [filteredCDx, setFilteredCdx] = useState( + parsedCDx + ); + const [selectedAlterations, setSelectedAlterations] = useState< + SelectOption[] + >([]); + const [selectedGenes, setSelectedGenes] = useState([]); + const [selectedCancerTypes, setSelectedCancerTypes] = useState< + SelectOption[] + >([]); + const [selectedDrugs, setSelectedDrugs] = useState([]); + const [selectedCDxs, setSelectedCDxs] = useState([]); + + useEffect(() => { + const filterPresent = + selectedCancerTypes.length > 0 || + selectedDrugs.length > 0 || + selectedCDxs.length > 0 || + selectedAlterations.length > 0 || + selectedGenes.length > 0; + setHasFilter(filterPresent); + + const getFilteredCdx = async () => { + if (filterPresent) { + let rcts: TumorType[] = []; + for (const ct of selectedCancerTypes) { + rcts = rcts.concat( + await privateClient.utilRelevantTumorTypesGetUsingGET({ + tumorType: ct.label, + }) + ); + } + const filtered = parsedCDx.filter(cdx => { + if ( + selectedCDxs.length > 0 && + selectedCDxs.filter(selectedCDx => + cdx.name.toLowerCase().includes(selectedCDx.value.toLowerCase()) + ).length === 0 + ) { + return false; + } + if ( + selectedGenes.length > 0 && + selectedGenes.filter(selectedGene => + cdx.biomarkerAssociation.gene.includes(selectedGene.value) + ).length === 0 + ) { + return false; + } + + if (selectedCancerTypes.length > 0) { + if ( + cdx.biomarkerAssociation.cancerTypes.filter(ct => { + if ( + rcts.filter(rct => { + if (rct.code) { + return rct.code === ct.code || rct.subtype === ct.subtype; + } else { + return rct.mainType === ct.mainType; + } + }).length === 0 + ) { + return false; + } + return true; + }).length === 0 + ) { + return false; + } + } + if ( + selectedDrugs.length > 0 && + selectedDrugs.filter(selectedDrug => + cdx.biomarkerAssociation.drugs + .toLowerCase() + .includes(selectedDrug.value.toLowerCase()) + ).length === 0 + ) { + return false; + } + if ( + selectedAlterations.length > 0 && + cdx.biomarkerAssociation.alterations.filter(a => + selectedAlterations.some(sa => + sa.value.toLowerCase().includes(a.toLowerCase()) + ) + ).length === 0 + ) { + return false; + } + return true; + }); + setFilteredCdx([...filtered]); + } else { + setFilteredCdx(parsedCDx); + } + }; + + getFilteredCdx(); + }, [ + selectedGenes, + selectedCancerTypes, + selectedDrugs, + selectedCDxs, + selectedAlterations, + ]); + + const clearFilters = () => { + setSelectedCancerTypes([]); + setSelectedDrugs([]); + setSelectedCDxs([]); + setSelectedGenes([]); + setSelectedAlterations([]); + }; + + const columns: SearchColumn[] = [ + { + id: 'gene', + accessor: 'biomarkerAssociation.gene', + Header: Gene, + Cell(tableProps: { original: ICompanionDiagnosticDevice }): JSX.Element { + return ( + + ); + }, + }, + { + id: 'alterations', + accessor: 'biomarkerAssociation.alterations', + Header: Alteration(s), + Cell(tableProps: { original: ICompanionDiagnosticDevice }): JSX.Element { + return ( + + {tableProps.original.biomarkerAssociation.alterations.map(a => ( + + ))} + + ); + }, + defaultSortDesc: false, + sortMethod: sortByStringArray, + }, + { + id: 'cancerTypes', + accessor: 'biomarkerAssociation.cancerTypes', + Header: Cancer Type(s), + Cell(tableProps: { original: ICompanionDiagnosticDevice }): JSX.Element { + return ( + + {getAllTumorTypesName( + tableProps.original.biomarkerAssociation.cancerTypes + )} + + ); + }, + sortMethod: tumorTypeSortMethod, + minWidth: 150, + }, + { + id: 'drugs', + accessor: 'biomarkerAssociation.drugs', + Header: Drug(s), + Cell(tableProps: { original: ICompanionDiagnosticDevice }): JSX.Element { + return {tableProps.original.biomarkerAssociation.drugs}; + }, + minWidth: 150, + }, + { + id: 'name', + accessor: 'name', + Header: Companion Diagnostic Device, + onFilter: (data: ICompanionDiagnosticDevice, keyword) => + filterByKeyword(data.name, keyword), + Cell(tableProps: { original: ICompanionDiagnosticDevice }): JSX.Element { + return ( + + {`${tableProps.original.name} (${tableProps.original.manufacturer})`} + + ); + }, + minWidth: 200, + }, + { + id: 'specimenType', + accessor: 'specimenTypes', + Header: Specimen Type(s), + Cell(tableProps: { original: ICompanionDiagnosticDevice }): JSX.Element { + return {tableProps.original?.specimenTypes?.join(', ')}; + }, + sortMethod: sortByStringArray, + }, + { accessor: 'platformType', Header: Platform Type }, + { + id: 'fdaSubmission', + Header: ( + + Reference(s){' '} + {referenceColumnInfo}} + /> + + ), + Cell(tableProps: { original: ICompanionDiagnosticDevice }): JSX.Element { + return ( + + {tableProps.original.biomarkerAssociation.fdaSubmissions.map( + (fdaSubmission: IFdaSubmission) => { + return ; + } + )} + + ); + }, + sortable: false, + }, + ]; + + const filteredCancerTypes = useMemo(() => { + return _.chain(filteredCDx) + .map(cdx => getAllTumorTypesName(cdx.biomarkerAssociation.cancerTypes)) + .uniq() + .value(); + }, [filteredCDx]); + + const filteredCdxNames = useMemo(() => { + return _.chain(filteredCDx) + .map(cdx => cdx.name) + .uniq() + .value(); + }, [filteredCDx]); + + const filteredGenes = useMemo(() => { + return _.chain(filteredCDx) + .map(cdx => cdx.biomarkerAssociation.gene) + .uniq() + .value(); + }, [filteredCDx]); + + const filterSummary = useMemo(() => { + const uniqueDrugs = _.uniq( + _.flatMap(filteredCDx, 'biomarkerAssociation.drugs') + ); + return ( + <> + + Showing {filteredCDx.length} biomarker and cancer type-specific CDx + associations{' '} + + + ( + + + {`${filteredGenes.length} ${pluralize( + 'gene', + filteredGenes.length + )}`} + + + {`${filteredCancerTypes.length} ${pluralize( + 'cancer type', + filteredCancerTypes.length + )}`} + + + {`${uniqueDrugs.length} ${pluralize('drug', uniqueDrugs.length)}`} + + + {`${filteredCdxNames.length} ${pluralize( + 'companion diagnostic device', + filteredCDx.length + )}`} + + + ) + + + ); + }, [filteredCDx]); + + return ( + <> + + +

+ FDA Cleared or Approved Companion Diagnostic Devices +

+
+ Companion diagnostic devices (CDx) that are US- Food and Drug + Administration (FDA) approved or cleared to guide treatment + decisions in cancer for the safe and efficient use of oncology drugs + (per the FDA’s{' '} + + List of Cleared or Approved Companion Diagnostic Devices (In Vitro + and Imaging Tools) + + ). Only the companion diagnostics that are included in the FDA-drug + labels of {ONCOKB_TM} level 1 precision oncology drugs and determine + the list of {ONCOKB_TM} level 1 biomarkers are listed below. +
+ + + + + { + acc = acc.concat(curr.biomarkerAssociation.alterations); + return acc; + }, [] as string[]) + .uniq() + .map(alt => ({ + label: alt, + value: alt, + })) + .sortBy('label') + .value()} + isClearable={true} + isMulti + value={selectedAlterations} + closeMenuOnSelect={false} + onChange={(selectedOptions: any[] | undefined) => { + setSelectedAlterations(selectedOptions || []); + }} + /> + + + ct.label)} + onChange={(selectedOptions: any) => { + setSelectedCancerTypes(selectedOptions ? selectedOptions : []); + }} + /> + + + ({ + label: cdx.name, + value: cdx.name, + })) + ) + .uniqBy('label') + .sortBy('label') + .value()} + isClearable={true} + isMulti + value={selectedCDxs} + closeMenuOnSelect={false} + onChange={(selectedOption: any) => { + setSelectedCDxs(selectedOption || []); + }} + /> + + + + +
+
{filterSummary}
+ {hasFilter ? ( + + ) : undefined} +
+ + + + + + + + + + ); +}; + +export default CompanionDiagnosticDevicePage; diff --git a/src/main/webapp/app/pages/newsPage/NewsPage.tsx b/src/main/webapp/app/pages/newsPage/NewsPage.tsx index 7a6cd98b2..4ae22752f 100644 --- a/src/main/webapp/app/pages/newsPage/NewsPage.tsx +++ b/src/main/webapp/app/pages/newsPage/NewsPage.tsx @@ -91,6 +91,7 @@ export default class NewsPage extends React.Component<{
+ diff --git a/src/main/webapp/app/pages/newsPage/NewsPageContent.tsx b/src/main/webapp/app/pages/newsPage/NewsPageContent.tsx index 27a97197b..fcc9fb8d3 100644 --- a/src/main/webapp/app/pages/newsPage/NewsPageContent.tsx +++ b/src/main/webapp/app/pages/newsPage/NewsPageContent.tsx @@ -83,6 +83,8 @@ export const DRUGS_CURRENTLY_IN_ONCOKB = `Drug(s) currently in ${ONCOKB_TM}`; export const DRUGS_REMOVED_FROM_ONCOKB = `Drug(s) removed from ${ONCOKB_TM}`; export const DRUGS_DEMOTED_IN_ONCOKB = `Drug(s) demoted in ${ONCOKB_TM}`; export const DRUGS_PROMOTED_IN_ONCOKB = `Drug(s) promoted in ${ONCOKB_TM}`; +export const DRUGS_ASSOCIATED_WITH_CURRENT_LEVEL = + 'Drug(s) Associated with the Current Level'; export const CURRENT_SENSITIVITY_LEVEL = 'Current Sensitivity Level'; export const CURRENT_RESISTANCE_LEVEL = 'Current Resistance Level'; export const PREVIOUS_BIOMARKER_ASSOCIATION = 'Previous Biomarker Association'; @@ -123,7 +125,7 @@ export const CHANGED_ANNOTATION_LEVEL_WITH_EVIDENCE_COLUMNS = [ { name: GENE }, { name: MUTATION }, { name: CANCER_TYPE }, - { name: DRUGS }, + { name: DRUGS_ASSOCIATED_WITH_CURRENT_LEVEL }, { name: PREVIOUS_LEVEL }, { name: CURRENT_LEVEL }, { name: EVIDENCE }, @@ -238,6 +240,136 @@ const EVIDENCE_COLUMN_SEPARATOR = '; '; // https://stackoverflow.com/questions/41947168/is-it-possible-to-use-keyof-operator-on-literals-instead-of-interfaces export const NEWS_BY_DATE: { [date: string]: NewsData } = { + '05012024': { + priorityNews: [ + + Release of the{' '} + + "FDA Cleared or Approved Companion Diagnostic Devices" + {' '} + (CDx) page, which includes the companion diagnostics that are listed in + the FDA-drug labels of {ONCOKB_TM} level 1 precision oncology drugs{' '} + , + + We have updated our FAQ page{' '} + with the most commonly asked questions of 2023. Take a look at what our + users are asking us + , + ], + changedAnnotations: [ + { + columnHeaderType: + AnnotationColumnHeaderType.PROMOTION_TUMOR_TYPE_SPECIFIC_EVIDENCE, + title: + 'Updated therapeutic implications - Promotion of tumor type-specific level of evidence for an alteration', + content: [ + [ + 'BRAF', + 'Fusions', + 'Low-Grade Giloma', + 'Tovorafenib', + '3B', + '1', + + + + , + ], + [ + 'BRAF', + <> + {' '} + (excluding V600E) + , + 'Low-Grade Glioma', + 'Tovorafenib', + '3B', + '1', + + + + , + ], + [ + 'ERBB2', + 'Amplification', + 'Salivary Gland Cancer', + 'Trastuzumab, Trastuzumab + Docetaxel, Ado-Trastuzumab Emtansine, Trastuzumab Deruxtecan, Trastuzumab + Pertuzumab', + '3B', + '2', + + + Inclusion in NCCN Head and Neck Cancer Guidelines V3.2024 + + + + , + ], + [ + 'ERBB2', + 'Amplification', + 'All Solid Tumors (excluding Breast Cancer, Esophagogastric Cancer, and Colorectal Cancer where ERBB2 amplification remains Level 1; Biliary Tract Cancer, Salivary Gland Cancer, and Uterine Cancer where ERBB2 amplification remains Level 2)', + 'Trastuzumab Deruxtecan', + '3B', + '3A', + + + + Clinical response demonstrated in various HER2-expressing (IHC + 3+) solid tumors + + + , + ], + ], + }, + { + columnHeaderType: AnnotationColumnHeaderType.ADDITIONAL_SAME_LEVEL_DRUG, + title: `Addition of therapy(s) associated with a tumor type-specific leveled alteration(s) (without changing the alteration's highest level of evidence)`, + content: [ + [ + 'BRAF', + 'V600E', + 'Low-Grade Glioma', + '1', + 'Dabrafenib + Trametinib (Level 1)', + 'Tovorafenib (Level 1)', + + + + , + ], + ], + }, + ], + newlyAddedGenes: [ + 'FGF7', + 'FOLR1', + 'GRB7', + 'MTHFD2', + 'MYO5A', + 'SLIT3', + 'UCHL1', + ], + }, '03212024': { priorityNews: [ diff --git a/src/main/webapp/app/pages/oncologyTherapiesPage/oncologyTherapiesPage.tsx b/src/main/webapp/app/pages/oncologyTherapiesPage/oncologyTherapiesPage.tsx index bf44706a1..1b3ec890f 100644 --- a/src/main/webapp/app/pages/oncologyTherapiesPage/oncologyTherapiesPage.tsx +++ b/src/main/webapp/app/pages/oncologyTherapiesPage/oncologyTherapiesPage.tsx @@ -474,7 +474,7 @@ const OncologyTherapiesPage: React.FunctionComponent<{}> = props => { 'https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications' } > - Content current as of 1/19/2024 + Content current as of 4/23/2024
diff --git a/src/main/webapp/app/routes/routes.tsx b/src/main/webapp/app/routes/routes.tsx index 38be14da9..7f590cc44 100644 --- a/src/main/webapp/app/routes/routes.tsx +++ b/src/main/webapp/app/routes/routes.tsx @@ -36,6 +36,7 @@ import ReadOnlyMode from 'app/shared/readonly/ReadOnlyMode'; import * as QueryString from 'query-string'; import OncologyTherapiesPage from 'app/pages/oncologyTherapiesPage/oncologyTherapiesPage'; import { NewsPageNavTab } from 'app/pages/newsPage/NewsPageNavTab'; +import CompanionDiagnosticDevicePage from 'app/pages/companionDiagnosticDevicesPage/companionDiagnosticDevicePage'; const getOldLevelsRedirectRoute = (hash: string) => { const queryStrings = QueryString.parse(hash) as { @@ -161,6 +162,13 @@ const AppRouts = (props: { path={PAGE_ROUTE.ONCOLOGY_TX} component={OncologyTherapiesPage} /> + cancerType.code === this.props.cancerType - ); - if (matchedSubtype) { - return { - label: matchedSubtype.subtype, - value: matchedSubtype.code, - }; - } else { - return { - label: this.props.cancerType, - value: this.props.cancerType, - }; - } - } else { - return null; - } + return ( + this.props.cancerTypes?.map(ct => { + const matchedSubtype = _.find( + this.allSubtypes, + cancerType => cancerType.code === ct + ); + if (matchedSubtype) { + return { + label: matchedSubtype.subtype, + value: matchedSubtype.code, + }; + } else { + return { + label: ct, + value: ct, + }; + } + }) || [] + ); } @computed @@ -98,9 +98,22 @@ export default class CancerTypeSelect extends React.Component< } render() { + if (this.props.isMulti) { + return ( + {data.label}} diff --git a/src/main/webapp/app/shared/links/FdaSubmissionLink.tsx b/src/main/webapp/app/shared/links/FdaSubmissionLink.tsx new file mode 100644 index 000000000..999738f33 --- /dev/null +++ b/src/main/webapp/app/shared/links/FdaSubmissionLink.tsx @@ -0,0 +1,28 @@ +import React from 'react'; +import { getFdaSubmissionNumber, toAppLocalDateFormat } from '../utils/Utils'; +import { FDA_SUBMISSION_URL_SUFFIX } from 'app/config/constants'; +import { Linkout } from './Linkout'; +import { IFdaSubmission } from 'app/pages/companionDiagnosticDevicesPage/companionDiagnosticDevicePage'; + +const FDA_SUBMISSION_BASE_URL = + 'https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/'; + +export const FdaSubmissionLink: React.FunctionComponent<{ + fdaSubmission: IFdaSubmission; +}> = props => { + const submissionNumber = getFdaSubmissionNumber( + props.fdaSubmission.number, + props.fdaSubmission.supplementNumber + ); + const date = toAppLocalDateFormat(props.fdaSubmission.decisionDate); + const link = + FDA_SUBMISSION_BASE_URL + + FDA_SUBMISSION_URL_SUFFIX[props.fdaSubmission.type.type] + + '?id=' + + submissionNumber.replace('/', ''); + return ( + + {submissionNumber} ({date}) + + ); +}; diff --git a/src/main/webapp/app/shared/utils/FileUtils.ts b/src/main/webapp/app/shared/utils/FileUtils.ts new file mode 100644 index 000000000..2381186ef --- /dev/null +++ b/src/main/webapp/app/shared/utils/FileUtils.ts @@ -0,0 +1,11 @@ +export function downloadFile( + fileName: string, + content: string, + options: BlobPropertyBag = { type: 'text/tsv' } +) { + const blob = new Blob([content], options); + const downloadLink = document.createElement('a'); + downloadLink.href = URL.createObjectURL(blob); + downloadLink.download = fileName; + downloadLink.click(); +} diff --git a/src/main/webapp/app/shared/utils/ReactTableUtils.ts b/src/main/webapp/app/shared/utils/ReactTableUtils.ts index 3cb2116b5..95fb92f40 100644 --- a/src/main/webapp/app/shared/utils/ReactTableUtils.ts +++ b/src/main/webapp/app/shared/utils/ReactTableUtils.ts @@ -6,7 +6,11 @@ import { } from 'app/config/constants'; import _ from 'lodash'; import { Alteration, Citations } from '../api/generated/OncoKbAPI'; -import { levelOfEvidence2Level } from 'app/shared/utils/Utils'; +import { + getAllTumorTypesName, + levelOfEvidence2Level, +} from 'app/shared/utils/Utils'; +import { TumorType } from '../api/generated/OncoKbPrivateAPI'; export function sortByArrayIndexAsc(aIndex: number, bIndex: number) { if (aIndex === bIndex) { @@ -20,6 +24,10 @@ export function sortByArrayIndexAsc(aIndex: number, bIndex: number) { } } +export function sortByStringArray(a: string[], b: string[]) { + return a.join(', ').localeCompare(b.join(', ')); +} + export function sortByLevelWithLevels(a: string, b: string, levels: LEVELS[]) { a = levelOfEvidence2Level(a); b = levelOfEvidence2Level(b); @@ -152,3 +160,7 @@ export function mutationEffectSortMethod( mutationEffectOrder.indexOf(b) ); } + +export function tumorTypeSortMethod(a: TumorType[], b: TumorType[]) { + return getAllTumorTypesName(a).localeCompare(getAllTumorTypesName(b)); +} diff --git a/src/main/webapp/app/shared/utils/Utils.tsx b/src/main/webapp/app/shared/utils/Utils.tsx index 0be743242..e72041924 100644 --- a/src/main/webapp/app/shared/utils/Utils.tsx +++ b/src/main/webapp/app/shared/utils/Utils.tsx @@ -928,3 +928,12 @@ export const convertObjectArrayToDelimitedString = ( } return rows.join('\n'); }; + +export const getFdaSubmissionNumber = ( + primaryNumber: string, + supplementNumber?: string +) => { + return supplementNumber + ? `${primaryNumber}/${supplementNumber}` + : primaryNumber; +}; diff --git a/src/main/webapp/content/files/companionDiagnosticDevices/companion_diagnostic_devices.json b/src/main/webapp/content/files/companionDiagnosticDevices/companion_diagnostic_devices.json new file mode 100644 index 000000000..f053cd053 --- /dev/null +++ b/src/main/webapp/content/files/companionDiagnosticDevices/companion_diagnostic_devices.json @@ -0,0 +1,16753 @@ +[ + { + "id": 1, + "name": "Abbott RealTime IDH1 ", + "manufacturer": "Abbott Molecular, Inc.", + "indicationDetails": null, + "platformType": "PCR", + "lastUpdated": "2024-01-11T17:00:37.809127Z", + "fdaSubmissions": [ + { + "id": 1, + "number": "P170041", + "supplementNumber": "", + "deviceName": "Abbott RealTime IDH1", + "genericName": "Somatic gene mutation detection system", + "dateReceived": "2017-12-05T00:00:00Z", + "decisionDate": "2018-07-20T00:00:00Z", + "description": "Approval for the Abbott RealTime IDH1. Abbott RealTime IDH1 is an in vitro polymerase chain reaction (PCR) assay for the qualitative detection of single nucleotide variants (SNVs) coding five IDH1 R132 mutations (R132C, R132H, R132G, R132S, and R132L) in DNA extracted from human blood (EDTA) or bone marrow (EDTA). Abbott RealTime IDH1 is for use with the Abbott m2000rt System.Abbott RealTime IDH1 is indicated as an aid in identifying acute myeloid leukemia (AML) patients with an isocitrate dehydrogenase-1 (IDH1) mutation for treatment with TIBSOVO® (ivosidenib). This test is for prescription use only.", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 1, + "name": null, + "associationCancerTypes": [ + { + "id": 1, + "relation": "INCLUSION", + "cancerType": { + "id": 476, + "code": "AML", + "color": "LightSalmon", + "level": 3, + "mainType": "Leukemia", + "subtype": "Acute Myeloid Leukemia", + "tissue": "Myeloid", + "tumorForm": "LIQUID" + } + } + ], + "alterations": [ + { + "id": 9271, + "type": "PROTEIN_CHANGE", + "name": "R132C", + "alteration": "R132C", + "proteinChange": "R132C", + "start": 132, + "end": 132, + "refResidues": "R", + "variantResidues": "C", + "genes": [ + { + "id": 23182, + "entrezGeneId": 3417, + "hugoSymbol": "IDH1", + "hgncId": "5382", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 9272, + "type": "PROTEIN_CHANGE", + "name": "R132H", + "alteration": "R132H", + "proteinChange": "R132H", + "start": 132, + "end": 132, + "refResidues": "R", + "variantResidues": "H", + "genes": [ + { + "id": 23182, + "entrezGeneId": 3417, + "hugoSymbol": "IDH1", + "hgncId": "5382", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 9273, + "type": "PROTEIN_CHANGE", + "name": "R132G", + "alteration": "R132G", + "proteinChange": "R132G", + "start": 132, + "end": 132, + "refResidues": "R", + "variantResidues": "G", + "genes": [ + { + "id": 23182, + "entrezGeneId": 3417, + "hugoSymbol": "IDH1", + "hgncId": "5382", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 9274, + "type": "PROTEIN_CHANGE", + "name": "R132S", + "alteration": "R132S", + "proteinChange": "R132S", + "start": 132, + "end": 132, + "refResidues": "R", + "variantResidues": "S", + "genes": [ + { + "id": 23182, + "entrezGeneId": 3417, + "hugoSymbol": "IDH1", + "hgncId": "5382", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 9275, + "type": "PROTEIN_CHANGE", + "name": "R132L", + "alteration": "R132L", + "proteinChange": "R132L", + "start": 132, + "end": 132, + "refResidues": "R", + "variantResidues": "L", + "genes": [ + { + "id": 23182, + "entrezGeneId": 3417, + "hugoSymbol": "IDH1", + "hgncId": "5382", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 1, + "name": null, + "drugs": [ + { + "id": 29, + "uuid": "6e09176b-e044-4190-8bbd-767c907577eb", + "name": "Ivosidenib" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + }, + { + "id": 2, + "number": "P170041", + "supplementNumber": "S007", + "deviceName": "Abbott RealTime IDH1", + "genericName": "Somatic gene mutation detection system", + "dateReceived": "2023-06-27T00:00:00Z", + "decisionDate": "2023-10-24T00:00:00Z", + "description": "Approval for expanding the indication for use of Abbott RealTime IDH1 as an aid in identifying myelodysplastic syndrome (MDS) patients with isocitrate dehydrogenase-1 (IDH1) mutation for treatment with TIBSOVO® (ivosidenib).", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 2, + "name": null, + "associationCancerTypes": [ + { + "id": 2, + "relation": "INCLUSION", + "cancerType": { + "id": 411, + "code": "MDS", + "color": "LightSalmon", + "level": 3, + "mainType": "Myelodysplastic Syndromes", + "subtype": "Myelodysplastic Syndromes", + "tissue": "Myeloid", + "tumorForm": "LIQUID" + } + } + ], + "alterations": [ + { + "id": 9271, + "type": "PROTEIN_CHANGE", + "name": "R132C", + "alteration": "R132C", + "proteinChange": "R132C", + "start": 132, + "end": 132, + "refResidues": "R", + "variantResidues": "C", + "genes": [ + { + "id": 23182, + "entrezGeneId": 3417, + "hugoSymbol": "IDH1", + "hgncId": "5382", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 9272, + "type": "PROTEIN_CHANGE", + "name": "R132H", + "alteration": "R132H", + "proteinChange": "R132H", + "start": 132, + "end": 132, + "refResidues": "R", + "variantResidues": "H", + "genes": [ + { + "id": 23182, + "entrezGeneId": 3417, + "hugoSymbol": "IDH1", + "hgncId": "5382", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 9273, + "type": "PROTEIN_CHANGE", + "name": "R132G", + "alteration": "R132G", + "proteinChange": "R132G", + "start": 132, + "end": 132, + "refResidues": "R", + "variantResidues": "G", + "genes": [ + { + "id": 23182, + "entrezGeneId": 3417, + "hugoSymbol": "IDH1", + "hgncId": "5382", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 9274, + "type": "PROTEIN_CHANGE", + "name": "R132S", + "alteration": "R132S", + "proteinChange": "R132S", + "start": 132, + "end": 132, + "refResidues": "R", + "variantResidues": "S", + "genes": [ + { + "id": 23182, + "entrezGeneId": 3417, + "hugoSymbol": "IDH1", + "hgncId": "5382", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 9275, + "type": "PROTEIN_CHANGE", + "name": "R132L", + "alteration": "R132L", + "proteinChange": "R132L", + "start": 132, + "end": 132, + "refResidues": "R", + "variantResidues": "L", + "genes": [ + { + "id": 23182, + "entrezGeneId": 3417, + "hugoSymbol": "IDH1", + "hgncId": "5382", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 2, + "name": null, + "drugs": [ + { + "id": 29, + "uuid": "6e09176b-e044-4190-8bbd-767c907577eb", + "name": "Ivosidenib" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. 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This database may be searched by a variety of fields and is updated once a week." + } + }, + { + "id": 3, + "number": "P170041", + "supplementNumber": "S006", + "deviceName": "Abbott RealTime IDH1, Abbott RealTime IDH1 Amplification Reagent Kit, Abbott RealTime IDH1 Control Kit, Abbott RealTime", + "genericName": "Somatic gene mutation detection system", + "dateReceived": "2021-12-17T00:00:00Z", + "decisionDate": "2022-12-01T00:00:00Z", + "description": "Approval to expand the indications for use of the Abbott RealTime IDH1 Assay to include a companion diagnostic indication for the detection of isocitrate dehydrogenase-1 (IDH1) mutations in patients with acute myeloid leukemia (AML) who may benefit from treatment with REZLIDHIA (olutasidenib).", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 3, + "name": null, + "associationCancerTypes": [ + { + "id": 3, + "relation": "INCLUSION", + "cancerType": { + "id": 476, + "code": "AML", + "color": "LightSalmon", + "level": 3, + "mainType": "Leukemia", + "subtype": "Acute Myeloid Leukemia", + "tissue": "Myeloid", + "tumorForm": "LIQUID" + } + } + ], + "alterations": [ + { + "id": 9271, + "type": "PROTEIN_CHANGE", + "name": "R132C", + "alteration": "R132C", + "proteinChange": "R132C", + "start": 132, + "end": 132, + "refResidues": "R", + "variantResidues": "C", + "genes": [ + { + "id": 23182, + "entrezGeneId": 3417, + "hugoSymbol": "IDH1", + "hgncId": "5382", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 9272, + "type": "PROTEIN_CHANGE", + "name": "R132H", + "alteration": "R132H", + "proteinChange": "R132H", + "start": 132, + "end": 132, + "refResidues": "R", + "variantResidues": "H", + "genes": [ + { + "id": 23182, + "entrezGeneId": 3417, + "hugoSymbol": "IDH1", + "hgncId": "5382", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 9273, + "type": "PROTEIN_CHANGE", + "name": "R132G", + "alteration": "R132G", + "proteinChange": "R132G", + "start": 132, + "end": 132, + "refResidues": "R", + "variantResidues": "G", + "genes": [ + { + "id": 23182, + "entrezGeneId": 3417, + "hugoSymbol": "IDH1", + "hgncId": "5382", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 9274, + "type": "PROTEIN_CHANGE", + "name": "R132S", + "alteration": "R132S", + "proteinChange": "R132S", + "start": 132, + "end": 132, + "refResidues": "R", + "variantResidues": "S", + "genes": [ + { + "id": 23182, + "entrezGeneId": 3417, + "hugoSymbol": "IDH1", + "hgncId": "5382", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 9275, + "type": "PROTEIN_CHANGE", + "name": "R132L", + "alteration": "R132L", + "proteinChange": "R132L", + "start": 132, + "end": 132, + "refResidues": "R", + "variantResidues": "L", + "genes": [ + { + "id": 23182, + "entrezGeneId": 3417, + "hugoSymbol": "IDH1", + "hgncId": "5382", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 3, + "name": null, + "drugs": [ + { + "id": 31, + "uuid": "6a19e843-8b1f-45bc-9203-5ba8b25e3246", + "name": "Olutasidenib" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. 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An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + } + ], + "specimenTypes": [ + { + "id": 4, + "type": "BONE_MARROW", + "name": "Bone marrow" + }, + { + "id": 7, + "type": "PERIF_BLOOD", + "name": "Peripheral Blood" + } + ] + }, + { + "id": 3, + "name": "Agilent Resolution ctDx FIRST assay ", + "manufacturer": "Resolution Bioscience, Inc.", + "indicationDetails": null, + "platformType": "NGS", + "lastUpdated": "2024-01-11T17:00:39.295650Z", + "fdaSubmissions": [ + { + "id": 5, + "number": "P210040", + "supplementNumber": "", + "deviceName": "RESOLUTION ctDx FIRST", + "genericName": "Next generation sequencing oncology panel, somatic or germline variant detection system", + "dateReceived": "2021-12-28T00:00:00Z", + "decisionDate": "2022-12-12T00:00:00Z", + "description": "Approval for the Agilent Resolution ctDx FIRST assay. The device is a qualitative next generation sequencing-based, in vitro diagnostic test that uses targeted hybrid-capture sequencing technology to detect and report single nucleotide variants (SNVs) and deletions in two genes. The Agilent Resolution ctDx FIRST assay utilizes circulating cell-free DNA (cfDNA) isolated from plasma of peripheral whole blood collected in Streck Cell-Free DNA Blood Collection Tubes (BCTs). The test is intended as a companion diagnostic to identify patients with non-small cell lung cancer (NSCLC) who may benefit from treatment with the targeted therapy listed in Table 1, in accordance with the approved therapeutic labeling.Table 1. Companion Diagnostic IndicationIndication: Non-small cell lung cancer (NSCLC); Biomarker: KRAS G12C; Therapy: KRAZATI (adagrasib) A negative result from a plasma specimen does not assure that the patient’s tumor is negative for genomic findings. Patients with NSCLC who are negative for the biomarker listed in Table 1 should be reflexed to tissue biopsy testing for Table 1 biomarker using an FDA-approved tumor tissue test, if feasible.Additionally, the test is intended to provide tumor mutation profiling for SNVs and deletions in the EGFR gene for use by qualified health care professionals in accordance with professional guidelines in oncology for patients with NSCLC. The test is for use with patients previously diagnosed with NSCLC and in conjunction with other laboratory and clinical findings.Genomic findings other than those listed in Table 1 are not prescriptive or conclusive for labeled use of any specific therapeutic product.The Agilent Resolution ctDx FIRST assay is a single-site assay performed at Resolution Bioscience, Inc.", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 5, + "name": null, + "associationCancerTypes": [ + { + "id": 5, + "relation": "INCLUSION", + "cancerType": { + "id": 64, + "code": "NSCLC", + "color": "Gainsboro", + "level": 2, + "mainType": "Non-Small Cell Lung Cancer", + "subtype": "Non-Small Cell Lung Cancer", + "tissue": "Lung", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 10208, + "type": "PROTEIN_CHANGE", + "name": "G12C", + "alteration": "G12C", + "proteinChange": "G12C", + "start": 12, + "end": 12, + "refResidues": "G", + "variantResidues": "C", + "genes": [ + { + "id": 30480, + "entrezGeneId": 3845, + "hugoSymbol": "KRAS", + "hgncId": "6407", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 5, + "name": null, + "drugs": [ + { + "id": 120, + "uuid": "0a7b3eb1-d1f0-4511-aaac-9a696955bf57", + "name": "Adagrasib" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + } + ], + "specimenTypes": [ + { + "id": 1, + "type": "CFDNA", + "name": "cfDNA from plasma" + } + ] + }, + { + "id": 4, + "name": "BRACAnalysis CDx ", + "manufacturer": "Myriad Genetic Laboratories, Inc.", + "indicationDetails": null, + "platformType": "PCR and Sanger sequencing", + "lastUpdated": "2024-01-11T17:00:41.228133Z", + "fdaSubmissions": [ + { + "id": 6, + "number": "P140020", + "supplementNumber": "", + "deviceName": "BRACANALYSIS CDX", + "genericName": "Cancer-related germline gene mutation detection system", + "dateReceived": "2014-09-24T00:00:00Z", + "decisionDate": "2014-12-19T00:00:00Z", + "description": "APPROVAL FOR THE BRACANALYSIS CDX. THIS DEVICE IS INDICATED AS FOLLOWS: BRACANALYSIS CDX IS AN IN VITRO DIAGNOSTIC DEVICE INTENDED FOR THE QUALITATIVE DETECTION AND CLASSIFICATION OF VARIANTS IN THE PROTEIN CODING REGIONS AND INTRON/EXON BOUNDARIES OF THE BRCA1 AND BRCA2 GENES USING GENOMIC DNA OBTAINED FROM WHOLE BLOOD SPECIMENS COLLECTED IN EDTA. SINGLE NUCLEOTIDE VARIANTS AND SMALL INSERTIONS AND DELETIONS (INDELS) ARE IDENTIFIED BY POLYMERASE CHAIN REACTION (PCR) AND SANGER SEQUENCING. LARGE DELETIONS AND DUPLICATIONS IN BRCA1 AND BRCA2 ARE DETECTED USING MULTIPLEX PCR. RESULTS OF THE TEST ARE USED AS AN AID IN IDENTIFYING OVARIAN CANCER PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BRCA VARIANTS ELIGIBLE FOR TREATMENT WITH LYNPARZA (OLAPARIB). THIS ASSAY IS FOR PROFESSIONAL USE ONLY AND IS TO BE PERFORMED ONLY AT MYRIAD GENETIC LABORATORIES, A SINGLE LABORATORY SITE LOCATED AT 320 WAKARA WAY, SALT LAKE CITY, UT 84108.", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 6, + "name": null, + "associationCancerTypes": [ + { + "id": 6, + "relation": "INCLUSION", + "cancerType": { + "id": 910, + "code": null, + "color": "LightBlue", + "level": 0, + "mainType": "Ovarian Cancer", + "subtype": null, + "tissue": "Ovary/Fallopian Tube", + "tumorForm": "SOLID" + } + }, + { + "id": 7, + "relation": "INCLUSION", + "cancerType": { + "id": 28, + "code": "OVARY", + "color": "LightBlue", + "level": 1, + "mainType": "Ovarian/Fallopian Tube Cancer, NOS", + "subtype": "Ovary/Fallopian Tube", + "tissue": "Ovary/Fallopian Tube", + "tumorForm": "SOLID" + } + }, + { + "id": 8, + "relation": "INCLUSION", + "cancerType": { + "id": 270, + "code": "PSEC", + "color": "Green", + "level": 2, + "mainType": "Peritoneal Cancer, NOS", + "subtype": "Peritoneal Serous Carcinoma", + "tissue": "Peritoneum", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 1951, + "type": "PROTEIN_CHANGE", + "name": "Oncogenic Mutations", + "alteration": "Oncogenic Mutations", + "proteinChange": "Oncogenic Mutations", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 41258, + "entrezGeneId": 672, + "hugoSymbol": "BRCA1", + "hgncId": "1100", + "evidences": null + } + ], + "consequence": { + "id": 39, + "term": "UNKNOWN", + "name": "Unknown", + "isGenerallyTruncating": false, + "description": "Unknown status", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 6, + "name": null, + "drugs": [ + { + "id": 145, + "uuid": "578af76a-2e8a-463a-b7bd-0494c91ad2a1", + "name": "Olaparib" + } + ] + } + ] + }, + { + "id": 7, + "name": null, + "associationCancerTypes": [ + { + "id": 9, + "relation": "INCLUSION", + "cancerType": { + "id": 910, + "code": null, + "color": "LightBlue", + "level": 0, + "mainType": "Ovarian Cancer", + "subtype": null, + "tissue": "Ovary/Fallopian Tube", + "tumorForm": "SOLID" + } + }, + { + "id": 10, + "relation": "INCLUSION", + "cancerType": { + "id": 28, + "code": "OVARY", + "color": "LightBlue", + "level": 1, + "mainType": "Ovarian/Fallopian Tube Cancer, NOS", + "subtype": "Ovary/Fallopian Tube", + "tissue": "Ovary/Fallopian Tube", + "tumorForm": "SOLID" + } + }, + { + "id": 11, + "relation": "INCLUSION", + "cancerType": { + "id": 270, + "code": "PSEC", + "color": "Green", + "level": 2, + "mainType": "Peritoneal Cancer, NOS", + "subtype": "Peritoneal Serous Carcinoma", + "tissue": "Peritoneum", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 2574, + "type": "PROTEIN_CHANGE", + "name": "Oncogenic Mutations", + "alteration": "Oncogenic Mutations", + "proteinChange": "Oncogenic Mutations", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 32518, + "entrezGeneId": 675, + "hugoSymbol": "BRCA2", + "hgncId": "1101", + "evidences": null + } + ], + "consequence": { + "id": 39, + "term": "UNKNOWN", + "name": "Unknown", + "isGenerallyTruncating": false, + "description": "Unknown status", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 7, + "name": null, + "drugs": [ + { + "id": 145, + "uuid": "578af76a-2e8a-463a-b7bd-0494c91ad2a1", + "name": "Olaparib" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + }, + { + "id": 7, + "number": "P140020", + "supplementNumber": "S016", + "deviceName": "BRACAnalysis CDx", + "genericName": "Cancer-related germline gene mutation detection system", + "dateReceived": "2018-06-29T00:00:00Z", + "decisionDate": "2018-10-16T00:00:00Z", + "description": "Approval for extending the label claim of the BRACAnalysis CDx® to include treatment and maintenance indications for Rubraca® (rucaparib) in ovarian cancer patients.", + "curated": true, + "genetic": false, + "note": null, + "associations": [ + { + "id": 8, + "name": null, + "associationCancerTypes": [ + { + "id": 12, + "relation": "INCLUSION", + "cancerType": { + "id": 910, + "code": null, + "color": "LightBlue", + "level": 0, + "mainType": "Ovarian Cancer", + "subtype": null, + "tissue": "Ovary/Fallopian Tube", + "tumorForm": "SOLID" + } + }, + { + "id": 13, + "relation": "INCLUSION", + "cancerType": { + "id": 28, + "code": "OVARY", + "color": "LightBlue", + "level": 1, + "mainType": "Ovarian/Fallopian Tube Cancer, NOS", + "subtype": "Ovary/Fallopian Tube", + "tissue": "Ovary/Fallopian Tube", + "tumorForm": "SOLID" + } + }, + { + "id": 14, + "relation": "INCLUSION", + "cancerType": { + "id": 270, + "code": "PSEC", + "color": "Green", + "level": 2, + "mainType": "Peritoneal Cancer, NOS", + "subtype": "Peritoneal Serous Carcinoma", + "tissue": "Peritoneum", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 1951, + "type": "PROTEIN_CHANGE", + "name": "Oncogenic Mutations", + "alteration": "Oncogenic Mutations", + "proteinChange": "Oncogenic Mutations", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 41258, + "entrezGeneId": 672, + "hugoSymbol": "BRCA1", + "hgncId": "1100", + "evidences": null + } + ], + "consequence": { + "id": 39, + "term": "UNKNOWN", + "name": "Unknown", + "isGenerallyTruncating": false, + "description": "Unknown status", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 8, + "name": null, + "drugs": [ + { + "id": 127, + "uuid": "75ceadf8-0171-4f62-97ff-b008b15effb3", + "name": "Rucaparib" + } + ] + } + ] + }, + { + "id": 9, + "name": null, + "associationCancerTypes": [ + { + "id": 15, + "relation": "INCLUSION", + "cancerType": { + "id": 910, + "code": null, + "color": "LightBlue", + "level": 0, + "mainType": "Ovarian Cancer", + "subtype": null, + "tissue": "Ovary/Fallopian Tube", + "tumorForm": "SOLID" + } + }, + { + "id": 16, + "relation": "INCLUSION", + "cancerType": { + "id": 28, + "code": "OVARY", + "color": "LightBlue", + "level": 1, + "mainType": "Ovarian/Fallopian Tube Cancer, NOS", + "subtype": "Ovary/Fallopian Tube", + "tissue": "Ovary/Fallopian Tube", + "tumorForm": "SOLID" + } + }, + { + "id": 17, + "relation": "INCLUSION", + "cancerType": { + "id": 270, + "code": "PSEC", + "color": "Green", + "level": 2, + "mainType": "Peritoneal Cancer, NOS", + "subtype": "Peritoneal Serous Carcinoma", + "tissue": "Peritoneum", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 2574, + "type": "PROTEIN_CHANGE", + "name": "Oncogenic Mutations", + "alteration": "Oncogenic Mutations", + "proteinChange": "Oncogenic Mutations", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 32518, + "entrezGeneId": 675, + "hugoSymbol": "BRCA2", + "hgncId": "1101", + "evidences": null + } + ], + "consequence": { + "id": 39, + "term": "UNKNOWN", + "name": "Unknown", + "isGenerallyTruncating": false, + "description": "Unknown status", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 9, + "name": null, + "drugs": [ + { + "id": 127, + "uuid": "75ceadf8-0171-4f62-97ff-b008b15effb3", + "name": "Rucaparib" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + }, + { + "id": 8, + "number": "P140020", + "supplementNumber": "S020", + "deviceName": "BRACAnalysis CDx", + "genericName": "Cancer-related germline gene mutation detection system", + "dateReceived": "2019-12-06T00:00:00Z", + "decisionDate": "2020-05-19T00:00:00Z", + "description": "Approval to expand the intended use of BRACAnalysis® CDx to include a companion diagnostic indication for BRCA1/2 mutations in patients with metastatic castration resistant prostate cancer who may benefit from treatment with Lynparza® (olaparib).", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 10, + "name": null, + "associationCancerTypes": [ + { + "id": 18, + "relation": "INCLUSION", + "cancerType": { + "id": 935, + "code": null, + "color": "Cyan", + "level": 0, + "mainType": "Prostate Cancer, NOS", + "subtype": null, + "tissue": "Prostate", + "tumorForm": "SOLID" + } + }, + { + "id": 19, + "relation": "INCLUSION", + "cancerType": { + "id": 987, + "code": null, + "color": "Cyan", + "level": 0, + "mainType": "Prostate Cancer", + "subtype": null, + "tissue": "Prostate", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 1951, + "type": "PROTEIN_CHANGE", + "name": "Oncogenic Mutations", + "alteration": "Oncogenic Mutations", + "proteinChange": "Oncogenic Mutations", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 41258, + "entrezGeneId": 672, + "hugoSymbol": "BRCA1", + "hgncId": "1100", + "evidences": null + } + ], + "consequence": { + "id": 39, + "term": "UNKNOWN", + "name": "Unknown", + "isGenerallyTruncating": false, + "description": "Unknown status", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 10, + "name": null, + "drugs": [ + { + "id": 145, + "uuid": "578af76a-2e8a-463a-b7bd-0494c91ad2a1", + "name": "Olaparib" + } + ] + } + ] + }, + { + "id": 11, + "name": null, + "associationCancerTypes": [ + { + "id": 20, + "relation": "INCLUSION", + "cancerType": { + "id": 935, + "code": null, + "color": "Cyan", + "level": 0, + "mainType": "Prostate Cancer, NOS", + "subtype": null, + "tissue": "Prostate", + "tumorForm": "SOLID" + } + }, + { + "id": 21, + "relation": "INCLUSION", + "cancerType": { + "id": 987, + "code": null, + "color": "Cyan", + "level": 0, + "mainType": "Prostate Cancer", + "subtype": null, + "tissue": "Prostate", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 2574, + "type": "PROTEIN_CHANGE", + "name": "Oncogenic Mutations", + "alteration": "Oncogenic Mutations", + "proteinChange": "Oncogenic Mutations", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 32518, + "entrezGeneId": 675, + "hugoSymbol": "BRCA2", + "hgncId": "1101", + "evidences": null + } + ], + "consequence": { + "id": 39, + "term": "UNKNOWN", + "name": "Unknown", + "isGenerallyTruncating": false, + "description": "Unknown status", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 11, + "name": null, + "drugs": [ + { + "id": 145, + "uuid": "578af76a-2e8a-463a-b7bd-0494c91ad2a1", + "name": "Olaparib" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + } + ], + "specimenTypes": [ + { + "id": 2, + "type": "WHOLE_BLOOD", + "name": "Whole blood" + } + ] + }, + { + "id": 5, + "name": "cobas 4800 BRAF V600 Mutation Test ", + "manufacturer": "Roche Molecular Systems, Inc.", + "indicationDetails": null, + "platformType": "PCR", + "lastUpdated": "2024-01-11T17:00:42.457238Z", + "fdaSubmissions": [ + { + "id": 9, + "number": "P110020", + "supplementNumber": "", + "deviceName": "COBAS 4800 BRAF V600 MUTATION TEST", + "genericName": "Somatic gene mutation detection system", + "dateReceived": "2011-04-25T00:00:00Z", + "decisionDate": "2011-08-17T00:00:00Z", + "description": "APPROVAL FOR THE COBAS 4800 BRAF V600 MUTATION TEST. THIS DEVICE IS INDICATED FOR: THE COBAS 4800 BRAF V600 MUTATION TEST IS AN IN VITRO DIAGNOSTIC DEVICE INTENDED FOR THE QUALITATIVE DETECTION OF THE BRAF V600E MUTATION IN DNA EXTRACTED FROM FORMALIN-FIXED, PARAFFIN-EMBEDDED HUMAN MELANOMA TISSUE. THE COBAS 4800 BRAF V600 MUTATION TEST IS A REAL-TIME PCR TEST ON THE COBAS 4800 SYSTEM, AND IS INTENDED TO BE USED AS AN AID IN SELECTING MELANOMA PATIENTS WHOSE TUMORS CARRY THE BRAF V600E MUTATION FOR TREATMENT WITH VEMURAFENIB.", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 12, + "name": null, + "associationCancerTypes": [ + { + "id": 22, + "relation": "INCLUSION", + "cancerType": { + "id": 172, + "code": "MEL", + "color": "Black", + "level": 2, + "mainType": "Melanoma", + "subtype": "Melanoma", + "tissue": "Skin", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 1388, + "type": "PROTEIN_CHANGE", + "name": "V600E", + "alteration": "V600E", + "proteinChange": "V600E", + "start": 600, + "end": 600, + "refResidues": "V", + "variantResidues": "E", + "genes": [ + { + "id": 41259, + "entrezGeneId": 673, + "hugoSymbol": "BRAF", + "hgncId": "1097", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 12, + "name": null, + "drugs": [ + { + "id": 4, + "uuid": "4e91da20-6cf0-4e07-995f-7f7db4c7c077", + "name": "Vemurafenib" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + }, + { + "id": 10, + "number": "P110020", + "supplementNumber": "S016", + "deviceName": "Roche cobas DNA Sample Preparation Kit, COBAS 4800 BRAF V600 MUTATION TEST", + "genericName": "Somatic gene mutation detection system", + "dateReceived": "2016-06-30T00:00:00Z", + "decisionDate": "2016-11-07T00:00:00Z", + "description": "Approval for the cobas® 4800 BRAF V600 Mutation Test. The cobas® 4800 BRAF V600 Mutation Test is an in vitro diagnostic device intended for the qualitative detection of BRAF V600E mutation in DNA extracted from formalin-fixed, paraffin-embedded human melanoma tissue. The cobas® 4800 BRAF V600 Mutation Test is a real-time PCR test on the cobas® 4800 System, and is intended to be used as an aid in selecting melanoma patients for treatment with the targeted therapies listed in the table below, in accordance with the approved therapeutic product labeling: Therapeutic Therapeutic Indication Test ResultZELBORAF® (vemurafenib) BRAF V600E Mutation DetectedCOTELLIC® (cobimetinib), in combination with ZELBORAF® (vemurafenib) BRAF V600E or V600K* Mutation Detected* *Due to cross-reactivity by the cobas® 4800 BRAF V600 Mutation Test, the clinical trial for cobimetinib, in combination with vemurafenib, included some patients whose tumor carried the BRAF V600K mutation. ", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 13, + "name": null, + "associationCancerTypes": [ + { + "id": 23, + "relation": "INCLUSION", + "cancerType": { + "id": 172, + "code": "MEL", + "color": "Black", + "level": 2, + "mainType": "Melanoma", + "subtype": "Melanoma", + "tissue": "Skin", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 1388, + "type": "PROTEIN_CHANGE", + "name": "V600E", + "alteration": "V600E", + "proteinChange": "V600E", + "start": 600, + "end": 600, + "refResidues": "V", + "variantResidues": "E", + "genes": [ + { + "id": 41259, + "entrezGeneId": 673, + "hugoSymbol": "BRAF", + "hgncId": "1097", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 1392, + "type": "PROTEIN_CHANGE", + "name": "V600K", + "alteration": "V600K", + "proteinChange": "V600K", + "start": 600, + "end": 600, + "refResidues": "V", + "variantResidues": "K", + "genes": [ + { + "id": 41259, + "entrezGeneId": 673, + "hugoSymbol": "BRAF", + "hgncId": "1097", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 13, + "name": null, + "drugs": [ + { + "id": 4, + "uuid": "4e91da20-6cf0-4e07-995f-7f7db4c7c077", + "name": "Vemurafenib" + }, + { + "id": 47, + "uuid": "eb357145-3b18-4aca-b75a-5e18dd2bf4f9", + "name": "Cobimetinib" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + } + ], + "specimenTypes": [ + { + "id": 3, + "type": "FFPE", + "name": "FFPE" + } + ] + }, + { + "id": 6, + "name": "cobas EGFR Mutation Test v1 ", + "manufacturer": "Roche Molecular Systems, Inc.", + "indicationDetails": null, + "platformType": "PCR", + "lastUpdated": "2024-01-11T17:00:42.770910Z", + "fdaSubmissions": [ + { + "id": 11, + "number": "P120019", + "supplementNumber": "", + "deviceName": "COBAS EGFR MUTATION TEST", + "genericName": "Somatic gene mutation detection system", + "dateReceived": "2012-11-08T00:00:00Z", + "decisionDate": "2013-07-15T00:00:00Z", + "description": "APPROVAL FOR THE COBAS® EGFR MUTATION TEST. THE COBAS® EGFR MUTATION TEST IS A REAL-TIME PCR TEST FOR THE QUALITATIVE DETECTION OF EXON 19 DELETIONS AND EXON 21 (L858R) SUBSTITUTION MUTATIONS OFTHE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) GENE IN DNA DERIVED FROM FORMALIN-FIXED PARAFFIN-EMBEDDED (FFPET) HUMAN NON-SMALL CELL LUNG CANCER (NSCLC) TUMOR TISSUE. THE TEST IS INTENDED TO BE USED AS AN AID IN SELECTING PATIENTS WITH METASTATIC NSCLC FOR WHOM TARCEVA® (ERLOTINIB), AN EGFR TYROSINE KINASE INHIBITOR (TK1), IS INDICATED. SPECIMENS ARE PROCESSED USING THE COBAS® DNA SAMPLE PREPARATION KIT FOR MANUAL SAMPLE PREPARATION AND THE COBAS Z 480 ANALYZER FOR AUTOMATED AMPLIFICATION AND DETECTION.", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 14, + "name": null, + "associationCancerTypes": [ + { + "id": 24, + "relation": "INCLUSION", + "cancerType": { + "id": 64, + "code": "NSCLC", + "color": "Gainsboro", + "level": 2, + "mainType": "Non-Small Cell Lung Cancer", + "subtype": "Non-Small Cell Lung Cancer", + "tissue": "Lung", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 5023, + "type": "PROTEIN_CHANGE", + "name": "L858R", + "alteration": "L858R", + "proteinChange": "L858R", + "start": 858, + "end": 858, + "refResidues": "L", + "variantResidues": "R", + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 5027, + "type": "PROTEIN_CHANGE", + "name": "Exon 19 in-frame deletions", + "alteration": "729_761del", + "proteinChange": "729_761del", + "start": 729, + "end": 761, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 11, + "term": "INFRAME_DELETION", + "name": "Inframe Deletion", + "isGenerallyTruncating": false, + "description": "An inframe non synonymous variant that deletes bases from the coding sequence", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 14, + "name": null, + "drugs": [ + { + "id": 114, + "uuid": "83754311-3f3b-4782-bfbf-08e71c790b9a", + "name": "Erlotinib" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + } + ], + "specimenTypes": [ + { + "id": 3, + "type": "FFPE", + "name": "FFPE" + } + ] + }, + { + "id": 7, + "name": "cobas EGFR Mutation Test v2 ", + "manufacturer": "Roche Molecular Systems, Inc.", + "indicationDetails": null, + "platformType": "PCR", + "lastUpdated": "2024-01-11T17:00:49.091757Z", + "fdaSubmissions": [ + { + "id": 12, + "number": "P120019", + "supplementNumber": "S007", + "deviceName": "COBAS EGFR MUTATION TEST V2", + "genericName": "Somatic gene mutation detection system", + "dateReceived": "2015-05-28T00:00:00Z", + "decisionDate": "2015-11-13T00:00:00Z", + "description": "APPROVAL FOR THE COBAS® EGFR MUTATION TEST V2. THIS DEVICE IS INDICATED FOR:THE COBAS® EGFR MUTATION TEST V2 IS A REAL-TIME PCR TEST FOR THE QUALITATIVE DETECTION OF DEFINED MUTATIONS OF THE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) GENE IN DNA DERIVED FROM FORMALIN-FIXED PARAFFIN-EMBEDDED TUMOR TISSUE (FFPET) FROM NON-SMALL CELL LUNG CANCER (NSCLC) PATIENTS. THE TEST IS INTENDED TO AID IN IDENTIFYING PATIENTS WITH NSCLC WHOSE TUMORS HAVE DEFINED EGFR MUTATIONS AND FOR WHOM SAFETY AND EFFICACY OF A DRUG HAVE BEEN ESTABLISHED AS FOLLOWS: TARCEVA® (ERLOTINIB)/EXON 19 DELETIONS AND L858R AND TAGRISSO® (OSIMERTINIB) T790M. DRUG SAFETY AND EFFICACY HAVE NOT BEEN ESTABLISHED FOR THE FOLLOWING EGFR MUTATIONS ALSO DETECTED BY THE COBAS® EGFR MUTATION TEST V2: TARCEVA® (ERLOTINIB)/G719X, EXON 20 INSERTIONS, T790M, S768I AND L861Q/TAGRISSO® (OSIMERTINIB)/G719X, EXON 19 DELETIONS, L858R, EXON 20 INSERTIONS, S768I, AND L861Q. FOR MANUAL SAMPLE PREPARATION, FFPET SPECIMENS ARE PROCESSED USING THE COBAS® DNA SAMPLE PREPARATION KIT AND THE COBAS Z 480 ANALYZER IS USED FOR AUTOMATED AMPLIFICATION AND DETECTION. ", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 15, + "name": null, + "associationCancerTypes": [ + { + "id": 25, + "relation": "INCLUSION", + "cancerType": { + "id": 64, + "code": "NSCLC", + "color": "Gainsboro", + "level": 2, + "mainType": "Non-Small Cell Lung Cancer", + "subtype": "Non-Small Cell Lung Cancer", + "tissue": "Lung", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 5025, + "type": "PROTEIN_CHANGE", + "name": "T790M", + "alteration": "T790M", + "proteinChange": "T790M", + "start": 790, + "end": 790, + "refResidues": "T", + "variantResidues": "M", + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 15, + "name": null, + "drugs": [ + { + "id": 72, + "uuid": "4c2c1261-bfc3-4180-8113-127194366320", + "name": "Osimertinib" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + }, + { + "id": 13, + "number": "P120019", + "supplementNumber": "S016", + "deviceName": "cobas EGFR Mutation Test v2", + "genericName": "Somatic gene mutation detection system", + "dateReceived": "2017-10-27T00:00:00Z", + "decisionDate": "2018-04-18T00:00:00Z", + "description": "Approval of the cobas® EGFR Mutation Test v2. The device is a real-time PCR test for the qualitative detection of defined mutations of the epidermal growth factor receptor (EGFR) gene in non-small cell lung cancer (NSCLC) patients. Defined EGFR mutations are detected using DNA isolated from formalin-fixed paraffin-embedded tumor tissue (FFPET) or circulating-free tumor DNA (cfDNA) from plasma derived from EDTA anti-coagulated peripheral whole blood. The test is indicated as a companion diagnostic to aid in selecting NSCLC patients for treatment with the targeted therapies listed in Table 1 below in accordance with the approved therapeutic product labeling:Table 1Drug FFPET PlasmaTARCEVA® (erlotinib) Exon 19 deletions and L858R Exon 19 deletions and L858RTAGRISSO® (osimertinib) Exon 19 deletions, L858R, and T790M T790M*Patients with positive cobas® EGFR Mutation Test v2 test results using plasma specimens for the presence of the EGFR mutations listed above are eligible for treatment with the corresponding drug as indicated in Table 1 (see Note* for T790M). Patients who are negative for these mutations by this test using plasma specimens should be reflexed to routine biopsy and testing for EGFR mutations with the FFPET sample type.*The efficacy of TAGRISSO (osimertinib) has not been established in the EGFR T790M plasma-positive, tissue-negative or unknown population and clinical data for T790M plasma-positive patients are limited; therefore testing using plasma specimens is most appropriate for consideration in patients from whom a tumor biopsy cannot be obtained.Drug safety and efficacy have not been established for the following EGFR mutations also detected by the cobas® EGFR Mutation Test v2. Table 2Drug FFPET PlasmaTARCEVA® (erlotinib) G719X, Exon 20 insertions, T790M, S768I, and L861Q G719X, Exon 20 insertions, T790M, S768I, and L861QTAGRISSO® (osimertinib) G719X, Exon 20 insertions, S768I, and L861Q G719X, Exon 19 deletions, L858R, Exon 20 insertions, S768I, and L861QFor manual sample preparation, FFPET specimens are processed using the cobas® DNA Sample Preparation Kit and plasma specimens are processed using the cobas® cfDNA Sample Preparation Kit. The cobas z 480 analyzer is used for automated amplification and detection.", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 16, + "name": null, + "associationCancerTypes": [ + { + "id": 26, + "relation": "INCLUSION", + "cancerType": { + "id": 64, + "code": "NSCLC", + "color": "Gainsboro", + "level": 2, + "mainType": "Non-Small Cell Lung Cancer", + "subtype": "Non-Small Cell Lung Cancer", + "tissue": "Lung", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 5023, + "type": "PROTEIN_CHANGE", + "name": "L858R", + "alteration": "L858R", + "proteinChange": "L858R", + "start": 858, + "end": 858, + "refResidues": "L", + "variantResidues": "R", + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 5027, + "type": "PROTEIN_CHANGE", + "name": "Exon 19 in-frame deletions", + "alteration": "729_761del", + "proteinChange": "729_761del", + "start": 729, + "end": 761, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 11, + "term": "INFRAME_DELETION", + "name": "Inframe Deletion", + "isGenerallyTruncating": false, + "description": "An inframe non synonymous variant that deletes bases from the coding sequence", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 16, + "name": null, + "drugs": [ + { + "id": 72, + "uuid": "4c2c1261-bfc3-4180-8113-127194366320", + "name": "Osimertinib" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + }, + { + "id": 14, + "number": "P120019", + "supplementNumber": "S018", + "deviceName": "cobas EGFR Mutation Test v2", + "genericName": "Somatic gene mutation detection system", + "dateReceived": "2017-11-30T00:00:00Z", + "decisionDate": "2018-04-18T00:00:00Z", + "description": "The cobas® EGFR Mutation Test v2 is a real-time PCR test for the qualitative detection of defined mutations of the epidermal growth factor receptor (EGFR) gene in non-small cell lung cancer (NSCLC) patients. Defined EGFR mutations are detected using DNA isolated from formalin-fixed paraffin-embedded tumor tissue (FFPET) or circulating-free tumor DNA (cfDNA) from plasma derived from EDTA anti-coagulated peripheral whole blood.The test is indicated as a companion diagnostic to aid in selecting NSCLC patients for treatment with the targeted therapies listed in Table 1 below in accordance with the approved therapeutic product labeling:Table 1 Drug FFPET PlasmaTARCEVA® (erlotinib) Exon 19 deletions and L858R Exon 19 deletions and L858RTAGRISSO® (osimertinib) Exon 19 deletions, L858R and T790M Exon 19 deletions, L858R and T790M*Patients with positive cobas® EGFR Mutation Test v2 test results using plasma specimens for the presence of the EGFR mutations listed above are eligible for treatment with the corresponding drug as indicated in Table 1 (see Note* for T790M). Patients who are negative for these mutations by this test using plasma specimens should be reflexed to routine biopsy and testing for EGFR mutations with the FFPET sample type.*The efficacy of TAGRISSO® (osimertinib) has not been established in the EGFR T790M plasma-positive, tissue-negative or unknown population and clinical data for T790M plasma-positive patients are limited; therefore testing using plasma specimens is most appropriate for consideration in patients from whom a tumor biopsy cannot be obtained. Drug safety and efficacy have not been established for the following EGFR mutations also detected by the cobas® EGFR Mutation Test v2: Table 2 Drug FFPET Plasma TARCEVA® (erlotinib) G719X, Exon 20 insertions, T790M, S768I and L861Q G719X, Exon 20 insertions, T790M, S768I and L861Q TAGRISSO® (osimertinib) G719X, Exon 20 insertions, S768I, and L861Q G719X, Exon 20 insertions, S768I, and L861QFor manual sample preparation, FFPET specimens are processed using the cobas® DNA Sample Preparation Kit and plasma specimens are processed using the cobas® cfDNA Sample Preparation Kit. The cobas z 480 analyzer is used for automated amplification and detection.", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 17, + "name": null, + "associationCancerTypes": [ + { + "id": 27, + "relation": "INCLUSION", + "cancerType": { + "id": 64, + "code": "NSCLC", + "color": "Gainsboro", + "level": 2, + "mainType": "Non-Small Cell Lung Cancer", + "subtype": "Non-Small Cell Lung Cancer", + "tissue": "Lung", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 5023, + "type": "PROTEIN_CHANGE", + "name": "L858R", + "alteration": "L858R", + "proteinChange": "L858R", + "start": 858, + "end": 858, + "refResidues": "L", + "variantResidues": "R", + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 5027, + "type": "PROTEIN_CHANGE", + "name": "Exon 19 in-frame deletions", + "alteration": "729_761del", + "proteinChange": "729_761del", + "start": 729, + "end": 761, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 11, + "term": "INFRAME_DELETION", + "name": "Inframe Deletion", + "isGenerallyTruncating": false, + "description": "An inframe non synonymous variant that deletes bases from the coding sequence", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 17, + "name": null, + "drugs": [ + { + "id": 72, + "uuid": "4c2c1261-bfc3-4180-8113-127194366320", + "name": "Osimertinib" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + }, + { + "id": 15, + "number": "P120019", + "supplementNumber": "S019", + "deviceName": "Cobas EGFR Mutation Test v2, Cobas DNA and cfDNA Sample Preparation Kit", + "genericName": "Somatic gene mutation detection system", + "dateReceived": "2018-02-23T00:00:00Z", + "decisionDate": "0218-08-22T00:03:58Z", + "description": "Approval for the cobas® EGFR Mutation Test v2. The device is a real-time PCR test for the qualitative detection of defined mutations of the epidermal growth factor receptor (EGFR) gene in non-small cell lung cancer (NSCLC) patients. Defined EGFR mutations are detected using DNA isolated from formalin-fixed paraffin-embedded tumor tissue (FFPET) or circulating-free tumor DNA (cfDNA) from plasma derived from EDTA anti-coagulated peripheral whole blood.The test is indicated as a companion diagnostic to aid in selecting NSCLC patients for treatment with the targeted therapies listed in Table 1 below in accordance with the approved therapeutic product labeling:Table 1Drug FFPET PlasmaTARCEVA® (erlotinib) Exon 19 deletions and L858R Exon 19 deletions and L858RTAGRISSO® (osimertinib) Exon 19 deletions, L858R and T790M Exon 19 deletions, L858R and T790M* IRESSA® (gefitinib) Exon 19 deletions and L858R Exon 19 deletions and L858RPatients with positive cobas® EGFR Mutation Test v2 test results using plasma specimens for the presence of the EGFR mutations listed above are eligible for treatment with the corresponding drug as indicated in Table 1 (see Note* for T790M). Patients who are negative for these mutations by this test using plasma specimens should be reflexed to routine biopsy and testing for EGFR mutations with the FFPET sample type.Note: *The efficacy of TAGRISSO® (osimertinib) has not been established in the EGFR T790M plasma-positive, tissue-negative or unknown population and clinical data for T790M plasma-positive patients are limited; therefore testing using plasma specimens is most appropriate for consideration in patients from whom a tumor biopsy cannot be obtained.Drug safety and efficacy have not been established for the following EGFR mutations also detected by the cobas® EGFR Mutation Test v2:Table 2Drug FFPET PlasmaTARCEVA® (erlotinib) G719X, Exon 20 insertions, T790M, S768I and L861Q G719X, Exon 20 insertions, T790M, S768I and L861QTAGRISSO® (osimertinib) G719X, Exon 20 insertions, S768I, and L861Q G719X, Exon 20 insertions, S768I, and L861QIRESSA® (gefitinib) G719X, Exon 20 insertions, T790M, S768I and L861Q G719X, Exon 20 insertions, T790M, S768I and L861QFor manual sample preparation, FFPET specimens are processed using the cobas® DNA Sample Preparation Kit and plasma specimens are processed using the cobas® cfDNA Sample Preparation Kit. The cobas z 480 analyzer is used for automated amplification and detection.", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 18, + "name": null, + "associationCancerTypes": [ + { + "id": 28, + "relation": "INCLUSION", + "cancerType": { + "id": 64, + "code": "NSCLC", + "color": "Gainsboro", + "level": 2, + "mainType": "Non-Small Cell Lung Cancer", + "subtype": "Non-Small Cell Lung Cancer", + "tissue": "Lung", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 5023, + "type": "PROTEIN_CHANGE", + "name": "L858R", + "alteration": "L858R", + "proteinChange": "L858R", + "start": 858, + "end": 858, + "refResidues": "L", + "variantResidues": "R", + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 5027, + "type": "PROTEIN_CHANGE", + "name": "Exon 19 in-frame deletions", + "alteration": "729_761del", + "proteinChange": "729_761del", + "start": 729, + "end": 761, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 11, + "term": "INFRAME_DELETION", + "name": "Inframe Deletion", + "isGenerallyTruncating": false, + "description": "An inframe non synonymous variant that deletes bases from the coding sequence", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 18, + "name": null, + "drugs": [ + { + "id": 33, + "uuid": "b76d7b2b-b5fb-4561-892f-6b00bfaf0dfa", + "name": "Gefitinib" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + }, + { + "id": 16, + "number": "P120019", + "supplementNumber": "S031", + "deviceName": "cobas EGFR Mutation Test v2", + "genericName": "Somatic gene mutation detection system", + "dateReceived": "2020-04-30T00:00:00Z", + "decisionDate": "2020-10-27T00:00:00Z", + "description": "Approval for cobas® EGFR Mutation Test v2 label expansion to obtain companion diagnostic group labeling claim for EGFR Tyrosine Kinase Inhibitors (TKI) for specific EGFR mutations detected by the test.", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 19, + "name": null, + "associationCancerTypes": [ + { + "id": 29, + "relation": "INCLUSION", + "cancerType": { + "id": 64, + "code": "NSCLC", + "color": "Gainsboro", + "level": 2, + "mainType": "Non-Small Cell Lung Cancer", + "subtype": "Non-Small Cell Lung Cancer", + "tissue": "Lung", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 5023, + "type": "PROTEIN_CHANGE", + "name": "L858R", + "alteration": "L858R", + "proteinChange": "L858R", + "start": 858, + "end": 858, + "refResidues": "L", + "variantResidues": "R", + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 5027, + "type": "PROTEIN_CHANGE", + "name": "Exon 19 in-frame deletions", + "alteration": "729_761del", + "proteinChange": "729_761del", + "start": 729, + "end": 761, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 11, + "term": "INFRAME_DELETION", + "name": "Inframe Deletion", + "isGenerallyTruncating": false, + "description": "An inframe non synonymous variant that deletes bases from the coding sequence", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 19, + "name": null, + "drugs": [ + { + "id": 33, + "uuid": "b76d7b2b-b5fb-4561-892f-6b00bfaf0dfa", + "name": "Gefitinib" + } + ] + } + ] + }, + { + "id": 20, + "name": null, + "associationCancerTypes": [ + { + "id": 30, + "relation": "INCLUSION", + "cancerType": { + "id": 64, + "code": "NSCLC", + "color": "Gainsboro", + "level": 2, + "mainType": "Non-Small Cell Lung Cancer", + "subtype": "Non-Small Cell Lung Cancer", + "tissue": "Lung", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 5023, + "type": "PROTEIN_CHANGE", + "name": "L858R", + "alteration": "L858R", + "proteinChange": "L858R", + "start": 858, + "end": 858, + "refResidues": "L", + "variantResidues": "R", + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 5027, + "type": "PROTEIN_CHANGE", + "name": "Exon 19 in-frame deletions", + "alteration": "729_761del", + "proteinChange": "729_761del", + "start": 729, + "end": 761, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 11, + "term": "INFRAME_DELETION", + "name": "Inframe Deletion", + "isGenerallyTruncating": false, + "description": "An inframe non synonymous variant that deletes bases from the coding sequence", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 20, + "name": null, + "drugs": [ + { + "id": 114, + "uuid": "83754311-3f3b-4782-bfbf-08e71c790b9a", + "name": "Erlotinib" + } + ] + } + ] + }, + { + "id": 21, + "name": null, + "associationCancerTypes": [ + { + "id": 31, + "relation": "INCLUSION", + "cancerType": { + "id": 64, + "code": "NSCLC", + "color": "Gainsboro", + "level": 2, + "mainType": "Non-Small Cell Lung Cancer", + "subtype": "Non-Small Cell Lung Cancer", + "tissue": "Lung", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 5023, + "type": "PROTEIN_CHANGE", + "name": "L858R", + "alteration": "L858R", + "proteinChange": "L858R", + "start": 858, + "end": 858, + "refResidues": "L", + "variantResidues": "R", + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 5027, + "type": "PROTEIN_CHANGE", + "name": "Exon 19 in-frame deletions", + "alteration": "729_761del", + "proteinChange": "729_761del", + "start": 729, + "end": 761, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 11, + "term": "INFRAME_DELETION", + "name": "Inframe Deletion", + "isGenerallyTruncating": false, + "description": "An inframe non synonymous variant that deletes bases from the coding sequence", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 21, + "name": null, + "drugs": [ + { + "id": 58, + "uuid": "e1f45ae7-33ae-428c-9e77-da4a9b7270b6", + "name": "Afatinib" + } + ] + } + ] + }, + { + "id": 22, + "name": null, + "associationCancerTypes": [ + { + "id": 32, + "relation": "INCLUSION", + "cancerType": { + "id": 64, + "code": "NSCLC", + "color": "Gainsboro", + "level": 2, + "mainType": "Non-Small Cell Lung Cancer", + "subtype": "Non-Small Cell Lung Cancer", + "tissue": "Lung", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 5023, + "type": "PROTEIN_CHANGE", + "name": "L858R", + "alteration": "L858R", + "proteinChange": "L858R", + "start": 858, + "end": 858, + "refResidues": "L", + "variantResidues": "R", + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 5027, + "type": "PROTEIN_CHANGE", + "name": "Exon 19 in-frame deletions", + "alteration": "729_761del", + "proteinChange": "729_761del", + "start": 729, + "end": 761, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 11, + "term": "INFRAME_DELETION", + "name": "Inframe Deletion", + "isGenerallyTruncating": false, + "description": "An inframe non synonymous variant that deletes bases from the coding sequence", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 22, + "name": null, + "drugs": [ + { + "id": 72, + "uuid": "4c2c1261-bfc3-4180-8113-127194366320", + "name": "Osimertinib" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + }, + { + "id": 17, + "number": "P150044", + "supplementNumber": "", + "deviceName": "cobas EGFR MUTATION TEST v2", + "genericName": "Somatic gene mutation detection system", + "dateReceived": "2015-11-23T00:00:00Z", + "decisionDate": "2016-09-28T00:00:00Z", + "description": "The cobas® EGFR Mutation Test v2 is a real-time PCR test for the qualitative detection of defined mutations of the epidermal growth factor receptor (EGFR) gene in non-small cell lung cancer (NSCLC) patients. Defined EGFR mutations are detected using DNA isolated from formalin-fixed paraffin-embedded tumor tissue (FFPET) or circulating-free tumor DNA (cfDNA) from plasma derived from EDTA anti-coagulated peripheral whole blood.The test is indicated as a companion diagnostic to aid in selecting NSCLC patients for treatment with the targeted therapies listed in Table 1 below in accordance with the approved therapeutic product labeling:Table 1Drug FFPET PlasmaTARCEVA® (erlotinib) Exon 19 deletions and L858R Exon 19 deletions and L858RTAGRISSO (osimertinib) 790M T790M*Patients with positive cobas® EGFR Mutation Test v2 test results using plasma specimens for the presence of the EGFR mutations listed above are eligible for treatment with the corresponding drug as indicated in Table 1 (see Note* for T790M). Patients who are negative for these mutations by this test should be reflexed to routine biopsy and testing for EGFR mutations with the FFPET sample type. *The efficacy of TAGRISSO (osimertinib) has not been established in the EGFR T790M plasma-positive, tissue-negative or unknown population and clinical data for T790M plasma-positive patients are limited; therefore, testing using plasma specimens is most appropriate for consideration in patients from whom a tumor biopsy cannot be obtained.Drug safety and efficacy have not been established for the EGFR mutations listed in Table 2 below that are also detected by the cobas® EGFR Mutation Test v2: Table 2Drug FFPET PlasmaTARCEVA® (erlotinib) G719X, exon 20 insertions, T790M, S768I and L861Q G719X, exon 20 insertions, T790M, S768I and L861QTAGRISSO (osimertinib) G719X, exon 19 deletions, L858R, exon 20 insertions, S768I, and L861Q G719X, exon 19 deletions, L858R, exon 20 insertions, S768I, and L861QFor manual sample preparation, FFPET specimens are processed using the cobas® DNA Sample Preparation Kit and plasma specimens are processed using the cobas® cfDNA Sample Preparation Kit. The cobas z 480 analyzer is used for automated amplification and detection.", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 23, + "name": null, + "associationCancerTypes": [ + { + "id": 33, + "relation": "INCLUSION", + "cancerType": { + "id": 64, + "code": "NSCLC", + "color": "Gainsboro", + "level": 2, + "mainType": "Non-Small Cell Lung Cancer", + "subtype": "Non-Small Cell Lung Cancer", + "tissue": "Lung", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 5025, + "type": "PROTEIN_CHANGE", + "name": "T790M", + "alteration": "T790M", + "proteinChange": "T790M", + "start": 790, + "end": 790, + "refResidues": "T", + "variantResidues": "M", + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 23, + "name": null, + "drugs": [ + { + "id": 72, + "uuid": "4c2c1261-bfc3-4180-8113-127194366320", + "name": "Osimertinib" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + }, + { + "id": 18, + "number": "P150047", + "supplementNumber": "", + "deviceName": "cobas EGFR MUTATION TEST v2", + "genericName": "Somatic gene mutation detection system", + "dateReceived": "2015-12-09T00:00:00Z", + "decisionDate": "2016-06-01T00:00:00Z", + "description": "Approval for the cobas® EGFR Mutation Test v2 is a real-time PCR test for the qualitative detection of defined mutations of the epidermal growth factor receptor (EGFR) gene in non-small cell lung cancer (NSCLC) patients. Defined EGFR mutations are detected using DNA isolated from formalin-fixed paraffin-embedded tumor tissue (FFPET) or circulating-free tumor DNA (cfDNA) from plasma derived from EDTA anti-coagulated peripheral whole blood.The test is indicated as a companion diagnostic to aid in selecting NSCLC patients for treatment with the targeted therapies listed in Table 1 below in accordance with the approved therapeutic product labeling.Table 1 Drug FFPET PlasmaTARCEVA® (erlotinib) Exon 19 deletions and L858R Exon 19 deletions and L858RTAGRISSO (osimertinib) T790M Patients with positive cobas® EGFR Mutation Test v2 test results using plasma specimens for the presence of EGFR exon 19 deletions or L858R mutations are eligible for treatment with TARCEVA® (erlotinib). Patients who are negative for these mutations by this test should be reflexed to routine biopsy and testing for EGFR mutations with the FFPET sample type.Drug safety and efficacy have not been established for the EGFR mutations listed in Table 2 below that are also detected by the cobas® EGFR Mutation Test v2. Table 2 Drug FFPET PlasmaTARCEVA® (erlotinib) G719X, exon 20 insertions, T790M, S768I and L861Q G719X, exon 20 insertions, T790M, S768I and L861QTAGRISSO (osimertinib) G719X, exon 19 deletions, L858R, exon 20 insertions, S768I, and L861Q G719X, exon 19 deletions, L858R, exon 20 insertions, T790M, S768I, and L861QFor manual sample preparation, FFPET specimens are processed using the cobas® DNA Sample Preparation Kit and plasma specimens are processed using the cobas® cfDNA Sample Preparation Kit. The cobas z 480 analyzer is used for automated amplification and detection. ", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 24, + "name": null, + "associationCancerTypes": [ + { + "id": 34, + "relation": "INCLUSION", + "cancerType": { + "id": 64, + "code": "NSCLC", + "color": "Gainsboro", + "level": 2, + "mainType": "Non-Small Cell Lung Cancer", + "subtype": "Non-Small Cell Lung Cancer", + "tissue": "Lung", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 5023, + "type": "PROTEIN_CHANGE", + "name": "L858R", + "alteration": "L858R", + "proteinChange": "L858R", + "start": 858, + "end": 858, + "refResidues": "L", + "variantResidues": "R", + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 5027, + "type": "PROTEIN_CHANGE", + "name": "Exon 19 in-frame deletions", + "alteration": "729_761del", + "proteinChange": "729_761del", + "start": 729, + "end": 761, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 11, + "term": "INFRAME_DELETION", + "name": "Inframe Deletion", + "isGenerallyTruncating": false, + "description": "An inframe non synonymous variant that deletes bases from the coding sequence", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 24, + "name": null, + "drugs": [ + { + "id": 114, + "uuid": "83754311-3f3b-4782-bfbf-08e71c790b9a", + "name": "Erlotinib" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + } + ], + "specimenTypes": [ + { + "id": 3, + "type": "FFPE", + "name": "FFPE" + } + ] + }, + { + "id": 8, + "name": "cobas EZH2 Mutation Test ", + "manufacturer": "Roche Molecular Systems, Inc.", + "indicationDetails": null, + "platformType": "PCR", + "lastUpdated": "2024-01-11T17:00:49.431272Z", + "fdaSubmissions": [ + { + "id": 19, + "number": "P200014", + "supplementNumber": "", + "deviceName": "cobas® EZH2 Mutation Test", + "genericName": "Somatic gene mutation detection system", + "dateReceived": "2020-03-02T00:00:00Z", + "decisionDate": "2020-06-18T00:00:00Z", + "description": "Approval for The cobas® EZH2 Mutation Test. The device is a real-time allele-specific PCR test for qualitative detection of single nucleotide mutations for Y646N, Y646F or Y646X (Y646H, Y646S, or Y646C), A682G, and A692V of the EZH2 gene in DNA extracted from formalin fixed paraffin embedded (FFPE) human follicular lymphoma tumor tissue specimens. The cobas® EZH2 Mutation Test is intended for the identification of follicular lymphoma patients with an EZH2 mutation for treatment with TAZVERIK (tazemetostat), in accordance with the approved therapeutic product labeling.", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 25, + "name": null, + "associationCancerTypes": [ + { + "id": 35, + "relation": "INCLUSION", + "cancerType": { + "id": 774, + "code": "FL", + "color": "LimeGreen", + "level": 5, + "mainType": "Mature B-Cell Neoplasms", + "subtype": "Follicular Lymphoma", + "tissue": "Lymphoid", + "tumorForm": "LIQUID" + } + } + ], + "alterations": [ + { + "id": 7685, + "type": "PROTEIN_CHANGE", + "name": "Y646H", + "alteration": "Y646H", + "proteinChange": "Y646H", + "start": 646, + "end": 646, + "refResidues": "Y", + "variantResidues": "H", + "genes": [ + { + "id": 29916, + "entrezGeneId": 2146, + "hugoSymbol": "EZH2", + "hgncId": "3527", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 7686, + "type": "PROTEIN_CHANGE", + "name": "Y646S", + "alteration": "Y646S", + "proteinChange": "Y646S", + "start": 646, + "end": 646, + "refResidues": "Y", + "variantResidues": "S", + "genes": [ + { + "id": 29916, + "entrezGeneId": 2146, + "hugoSymbol": "EZH2", + "hgncId": "3527", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 7687, + "type": "PROTEIN_CHANGE", + "name": "Y646C", + 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An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + } + ], + "specimenTypes": [ + { + "id": 3, + "type": "FFPE", + "name": "FFPE" + } + ] + }, + { + "id": 9, + "name": "cobas KRAS Mutation Test ", + "manufacturer": "Roche Molecular Systems, Inc.", + "indicationDetails": null, + "platformType": "PCR", + "lastUpdated": "2024-01-11T17:00:50.367695Z", + "fdaSubmissions": [ + { + "id": 20, + "number": "P140023", + "supplementNumber": "", + "deviceName": "COBAS KRAS MUTATION TEST", + "genericName": "Somatic gene mutation detection system", + "dateReceived": "2014-10-23T00:00:00Z", + "decisionDate": "2015-05-07T00:00:00Z", + "description": "APPROVAL FOR THE COBAS KRAS MUTATION TEST. THIS DEVICE IS INDICATED FOR THE FOLLOWING:THE COBAS KRAS MUTATION TEST, FOR USE WITH THE COBAS 4800 SYSTEM, IS A REAL-TIME PCR TEST FOR THE DETECTION OF SEVEN SOMATIC MUTATIONS IN CODONS 12 AND 13 OF THE KRAS GENE IN DNA DERIVED FROM FORMALIN-FIXED PARAFFIN-EMBEDDED HUMAN COLORECTAL CANCER (CRC) TUMOR TISSUE. 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An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + } + ], + "specimenTypes": [ + { + "id": 3, + "type": "FFPE", + "name": "FFPE" + } + ] + }, + { + "id": 10, + "name": "CRCDx RAS Mutation Detection Assay Kit ", + "manufacturer": "EntroGen, Inc.", + "indicationDetails": null, + "platformType": "PCR", + "lastUpdated": "2024-01-11T17:00:51.350125Z", + "fdaSubmissions": [ + { + "id": 21, + "number": "P220005", + "supplementNumber": "", + "deviceName": "CRCDx RAS Mutation Detection Assay Kit", + "genericName": "Somatic gene mutation detection system", + "dateReceived": "2022-04-20T00:00:00Z", + "decisionDate": "2023-09-29T00:00:00Z", + "description": "Approval for the CRCdx® RAS Mutation Detection Kit. 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An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + } + ], + "specimenTypes": [ + { + "id": 3, + "type": "FFPE", + "name": "FFPE" + } + ] + }, + { + "id": 11, + "name": "FoundationFocus CDxBRCA Assay ", + "manufacturer": "Foundation Medicine, Inc.", + "indicationDetails": null, + "platformType": "NGS", + "lastUpdated": "2024-01-11T17:00:52.172923Z", + "fdaSubmissions": [ + { + "id": 22, + "number": "P160018", + "supplementNumber": "", + "deviceName": "FoundationFocus CDxBRCA", + "genericName": "Next generation sequencing oncology panel, somatic or germline variant detection system", + "dateReceived": "2016-06-30T00:00:00Z", + "decisionDate": "2016-12-19T00:00:00Z", + "description": "Approval for The FoundationFocus CDxBRCA is a next generation sequencing based in vitro diagnostic device for qualitative detection of BRCA1 and BRCA2 alterations in formalin-fixed paraffin-embedded (FFPE) ovarian tumor tissue. The FoundationFocus CDxBRCA assay detects sequence alterations in BRCA1 and BRCA2 (BRCA1/2) genes. Results of the assay are used as an aid in identifying ovarian cancer patients for whom treatment with Rubraca (rucaparib) is being considered. If a patient is positive for any of the deleterious alterations specified in the BRCA1/2 classification, the patient may be eligible for treatment with Rubraca. This assay is to be performed at Foundation Medicine, Inc., a single laboratory site located at 150 Second Street, Cambridge, Massachusetts.", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 30, + "name": null, + "associationCancerTypes": [ + { + "id": 40, + "relation": "INCLUSION", + "cancerType": { + "id": 910, + "code": null, + "color": "LightBlue", + "level": 0, + "mainType": "Ovarian Cancer", + "subtype": null, + "tissue": "Ovary/Fallopian Tube", + "tumorForm": "SOLID" + } + }, + { + "id": 41, + "relation": "INCLUSION", + "cancerType": { + "id": 28, + "code": "OVARY", + "color": "LightBlue", + "level": 1, + "mainType": "Ovarian/Fallopian Tube Cancer, NOS", + "subtype": "Ovary/Fallopian Tube", + "tissue": "Ovary/Fallopian Tube", + "tumorForm": "SOLID" + } + }, + { + "id": 42, + "relation": "INCLUSION", + "cancerType": { + "id": 270, + "code": "PSEC", + "color": "Green", + "level": 2, + "mainType": "Peritoneal Cancer, NOS", + "subtype": "Peritoneal Serous Carcinoma", + "tissue": "Peritoneum", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 1951, + "type": "PROTEIN_CHANGE", + "name": "Oncogenic Mutations", + "alteration": "Oncogenic Mutations", + "proteinChange": "Oncogenic Mutations", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 41258, + "entrezGeneId": 672, + "hugoSymbol": "BRCA1", + "hgncId": "1100", + "evidences": null + } + ], + "consequence": { + "id": 39, + "term": "UNKNOWN", + "name": "Unknown", + "isGenerallyTruncating": false, + "description": "Unknown status", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 34, + "name": null, + "drugs": [ + { + "id": 127, + "uuid": "75ceadf8-0171-4f62-97ff-b008b15effb3", + "name": "Rucaparib" + } + ] + } + ] + }, + { + "id": 31, + "name": null, + "associationCancerTypes": [ + { + "id": 43, + "relation": "INCLUSION", + "cancerType": { + "id": 910, + "code": null, + "color": "LightBlue", + "level": 0, + "mainType": "Ovarian Cancer", + "subtype": null, + "tissue": "Ovary/Fallopian Tube", + "tumorForm": "SOLID" + } + }, + { + "id": 44, + "relation": "INCLUSION", + "cancerType": { + "id": 28, + "code": "OVARY", + "color": "LightBlue", + "level": 1, + "mainType": "Ovarian/Fallopian Tube Cancer, NOS", + "subtype": "Ovary/Fallopian Tube", + "tissue": "Ovary/Fallopian Tube", + "tumorForm": "SOLID" + } + }, + { + "id": 45, + "relation": "INCLUSION", + "cancerType": { + "id": 270, + "code": "PSEC", + "color": "Green", + "level": 2, + "mainType": "Peritoneal Cancer, NOS", + "subtype": "Peritoneal Serous Carcinoma", + "tissue": "Peritoneum", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 2574, + "type": "PROTEIN_CHANGE", + "name": "Oncogenic Mutations", + "alteration": "Oncogenic Mutations", + "proteinChange": "Oncogenic Mutations", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 32518, + "entrezGeneId": 675, + "hugoSymbol": "BRCA2", + "hgncId": "1101", + "evidences": null + } + ], + "consequence": { + "id": 39, + "term": "UNKNOWN", + "name": "Unknown", + "isGenerallyTruncating": false, + "description": "Unknown status", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 35, + "name": null, + "drugs": [ + { + "id": 127, + "uuid": "75ceadf8-0171-4f62-97ff-b008b15effb3", + "name": "Rucaparib" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + } + ], + "specimenTypes": [ + { + "id": 3, + "type": "FFPE", + "name": "FFPE" + } + ] + }, + { + "id": 12, + "name": "FoundationOne CDx ", + "manufacturer": "Foundation Medicine, Inc.", + "indicationDetails": null, + "platformType": "NGS", + "lastUpdated": "2024-01-11T17:01:02.995848Z", + "fdaSubmissions": [ + { + "id": 27, + "number": "P170019", + "supplementNumber": "S013", + "deviceName": "FoundationOne CDx (F1CDx)", + "genericName": "Next generation sequencing oncology panel, somatic or germline variant detection system", + "dateReceived": "2019-10-31T00:00:00Z", + "decisionDate": "2020-04-17T00:00:00Z", + "description": "Approval order for extending the label claim to include an indication for PEMAZYRE(pemigatinib)in cholangiocarcinoma patients with FGFR2 fusions and select rearrangements. 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An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + }, + { + "id": 23, + "number": "P170019", + "supplementNumber": "", + "deviceName": "FoundationOne CDx", + "genericName": "Next generation sequencing oncology panel, somatic or germline variant detection system", + "dateReceived": "2017-06-02T00:00:00Z", + "decisionDate": "2017-11-30T00:00:00Z", + "description": "Approval for the FoundationOne CDx (F1CDx). This device is a next generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens. The test is intended as a companion diagnostic to identify patients who may benefit from treatment with the targeted therapies listed in Table 1 in accordance with the approved therapeutic product labeling. Additionally, F1CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. The F1CDx assay is a single-site assay performed at Foundation Medicine, Inc.Table 1: Companion diagnostic indicationsIndication: Non-small cell lung cancer (NSCLC). - Biomarker: EGFR exon 19 deletions and EGFR exon 21 L858R alterations. Therapy: Gilotrif® (afatinib), Iressa® (gefitinib), or Tarceva® (erlotinib). - Biomarker: EGFR exon 20 T790M alterations. Therapy: Tagrisso® (osimertinib). - Biomarker: ALK rearrangements. Therapy: Alecensa® (alectinib), Xalkori® (crizotinib), or Zykadia® (ceritinib). - Biomarker: BRAF V600E. Therapy: Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib).Indication: Melanoma. - Biomarker: BRAF V600E. Therapy: Tafinlar® (dabrafenib) or Zelboraf® (vemurafenib) - Biomarker: BRAF V600E and V600K. Therapy: Mekinist® (trametinib) or Cotellic® (cobimetinib) in combination with Zelboraf® (vemurafenib).Indication: Breast cancer. Biomarker: ERBB2 (HER2) amplification. Therapy: Herceptin® (trastuzumab), Kadcyla® (ado-trastuzumab-emtansine), orPerjeta® (pertuzumab).Indication: Colorectal cancer. - Biomarker: KRAS wild-type (absence of mutations in codons 12 and 13). Therapy: Erbitux® (cetuximab) - Biomarker: KRAS wild-type (absence of mutations in exons 2, 3, and 4) and NRAS wild type (absence of mutations in exons 2, 3, and 4). Therapy: Vectibix® (panitumumab)Indication: Ovarian cancer. Biomarker: BRCA1/2 alterations. Therapy: Rubraca® (rucaparib)", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 32, + "name": null, + "associationCancerTypes": [ + { + "id": 46, + "relation": "INCLUSION", + "cancerType": { + "id": 64, + "code": "NSCLC", + "color": "Gainsboro", + "level": 2, + "mainType": "Non-Small Cell Lung Cancer", + "subtype": "Non-Small Cell Lung Cancer", + "tissue": "Lung", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 5023, + "type": "PROTEIN_CHANGE", + "name": "L858R", + "alteration": "L858R", + "proteinChange": "L858R", + "start": 858, + "end": 858, + "refResidues": "L", + "variantResidues": "R", + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 5027, + "type": "PROTEIN_CHANGE", + "name": "Exon 19 in-frame deletions", + "alteration": "729_761del", + "proteinChange": "729_761del", + "start": 729, + "end": 761, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 11, + "term": "INFRAME_DELETION", + "name": "Inframe Deletion", + "isGenerallyTruncating": false, + "description": "An inframe non synonymous variant that deletes bases from the coding sequence", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 36, + "name": null, + "drugs": [ + { + "id": 58, + "uuid": "e1f45ae7-33ae-428c-9e77-da4a9b7270b6", + "name": "Afatinib" + } + ] + } + ] + }, + { + "id": 33, + "name": null, + "associationCancerTypes": [ + { + "id": 47, + "relation": "INCLUSION", + "cancerType": { + "id": 64, + "code": "NSCLC", + "color": "Gainsboro", + "level": 2, + "mainType": "Non-Small Cell Lung Cancer", + "subtype": "Non-Small Cell Lung Cancer", + "tissue": "Lung", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 5023, + "type": "PROTEIN_CHANGE", + "name": "L858R", + "alteration": "L858R", + "proteinChange": "L858R", + "start": 858, + "end": 858, + "refResidues": "L", + "variantResidues": "R", + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 5027, + "type": "PROTEIN_CHANGE", + "name": "Exon 19 in-frame deletions", + "alteration": "729_761del", + "proteinChange": "729_761del", + "start": 729, + "end": 761, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 11, + "term": "INFRAME_DELETION", + "name": "Inframe Deletion", + "isGenerallyTruncating": false, + "description": "An inframe non synonymous variant that deletes bases from the coding sequence", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 37, + "name": null, + "drugs": [ + { + "id": 33, + "uuid": "b76d7b2b-b5fb-4561-892f-6b00bfaf0dfa", + "name": "Gefitinib" + } + ] + } + ] + }, + { + "id": 34, + "name": null, + "associationCancerTypes": [ + { + "id": 48, + "relation": "INCLUSION", + "cancerType": { + "id": 64, + "code": "NSCLC", + "color": "Gainsboro", + "level": 2, + "mainType": "Non-Small Cell Lung Cancer", + "subtype": "Non-Small Cell Lung Cancer", + "tissue": "Lung", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 5023, + "type": "PROTEIN_CHANGE", + "name": "L858R", + "alteration": "L858R", + "proteinChange": "L858R", + "start": 858, + "end": 858, + "refResidues": "L", + "variantResidues": "R", + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 5027, + "type": "PROTEIN_CHANGE", + "name": "Exon 19 in-frame deletions", + "alteration": "729_761del", + "proteinChange": "729_761del", + "start": 729, + "end": 761, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 11, + "term": "INFRAME_DELETION", + "name": "Inframe Deletion", + "isGenerallyTruncating": false, + "description": "An inframe non synonymous variant that deletes bases from the coding sequence", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 38, + "name": null, + "drugs": [ + { + "id": 114, + "uuid": "83754311-3f3b-4782-bfbf-08e71c790b9a", + "name": "Erlotinib" + } + ] + } + ] + }, + { + "id": 35, + "name": null, + "associationCancerTypes": [ + { + "id": 49, + "relation": "INCLUSION", + "cancerType": { + "id": 64, + "code": "NSCLC", + "color": "Gainsboro", + "level": 2, + "mainType": "Non-Small Cell Lung Cancer", + "subtype": "Non-Small Cell Lung Cancer", + "tissue": "Lung", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 5025, + "type": "PROTEIN_CHANGE", + "name": "T790M", + "alteration": "T790M", + "proteinChange": "T790M", + "start": 790, + "end": 790, + "refResidues": "T", + "variantResidues": "M", + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 39, + "name": null, + "drugs": [ + { + "id": 72, + "uuid": "4c2c1261-bfc3-4180-8113-127194366320", + "name": "Osimertinib" + } + ] + } + ] + }, + { + "id": 36, + "name": null, + "associationCancerTypes": [ + { + "id": 50, + "relation": "INCLUSION", + "cancerType": { + "id": 64, + "code": "NSCLC", + "color": "Gainsboro", + "level": 2, + "mainType": "Non-Small Cell Lung Cancer", + "subtype": "Non-Small Cell Lung Cancer", + "tissue": "Lung", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 559, + "type": "STRUCTURAL_VARIANT", + "name": "Fusions", + "alteration": "Fusions", + "proteinChange": "", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 21832, + "entrezGeneId": 238, + "hugoSymbol": "ALK", + "hgncId": "427", + "evidences": null + } + ], + "consequence": { + "id": 39, + "term": "UNKNOWN", + "name": "Unknown", + "isGenerallyTruncating": false, + "description": "Unknown status", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 40, + "name": null, + "drugs": [ + { + "id": 98, + "uuid": "ef2bee25-4fa3-40c4-a79f-4f885377afa7", + "name": "Alectinib" + } + ] + } + ] + }, + { + "id": 45, + "name": null, + "associationCancerTypes": [ + { + "id": 59, + "relation": "INCLUSION", + "cancerType": { + "id": 874, + "code": null, + "color": "SaddleBrown", + "level": 0, + "mainType": "Colorectal Cancer", + "subtype": null, + "tissue": "Bowel", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 12816, + "type": "NA", + "name": "Wildtype", + "alteration": "Wildtype", + "proteinChange": "", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 17596, + "entrezGeneId": 4893, + "hugoSymbol": "NRAS", + "hgncId": "7989", + "evidences": null + } + ], + "consequence": { + "id": 3, + "term": "ANY", + "name": "Any", + "isGenerallyTruncating": false, + "description": "Any variant", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 52, + "name": null, + "drugs": [ + { + "id": 65, + "uuid": "d7b1d12a-e942-4801-bb64-916c9bdfaaf3", + "name": "Panitumumab" + } + ] + }, + { + "id": 53, + "name": null, + "drugs": [ + { + "id": 65, + "uuid": "d7b1d12a-e942-4801-bb64-916c9bdfaaf3", + "name": "Panitumumab" + }, + { + "id": 103, + "uuid": "3bbe37b1-edc8-4c54-93f8-5360d9a83d69", + "name": "Chemotherapy" + } + ] + } + ] + }, + { + "id": 46, + "name": null, + "associationCancerTypes": [ + { + "id": 60, + "relation": "INCLUSION", + "cancerType": { + "id": 172, + "code": "MEL", + "color": "Black", + "level": 2, + "mainType": "Melanoma", + "subtype": "Melanoma", + "tissue": "Skin", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 1388, + "type": "PROTEIN_CHANGE", + "name": "V600E", + "alteration": "V600E", + "proteinChange": "V600E", + "start": 600, + "end": 600, + "refResidues": "V", + "variantResidues": "E", + "genes": [ + { + "id": 41259, + "entrezGeneId": 673, + "hugoSymbol": "BRAF", + "hgncId": "1097", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 1392, + "type": "PROTEIN_CHANGE", + "name": "V600K", + "alteration": "V600K", + "proteinChange": "V600K", + "start": 600, + "end": 600, + "refResidues": "V", + "variantResidues": "K", + "genes": [ + { + "id": 41259, + "entrezGeneId": 673, + "hugoSymbol": "BRAF", + "hgncId": "1097", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 54, + "name": null, + "drugs": [ + { + "id": 122, + "uuid": "fb2bb01c-c0ec-4641-abf7-87f486075022", + "name": "Trametinib" + } + ] + } + ] + }, + { + "id": 37, + "name": null, + "associationCancerTypes": [ + { + "id": 51, + "relation": "INCLUSION", + 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This database may be searched by a variety of fields and is updated once a week." + } + }, + { + "id": 31, + "number": "P170019", + "supplementNumber": "S029", + "deviceName": "FoundationOne CDx (F1CDx)", + "genericName": "Next generation sequencing oncology panel, somatic or germline variant detection system", + "dateReceived": "2021-04-19T00:00:00Z", + "decisionDate": "2022-02-18T00:00:00Z", + "description": "Approval order to expand the intended use of FoundationOne®CDx (F1CDx) to include a companion diagnostic (CDx) indication for the detection of microsatellite instability High (MSI-H) status in patients with solid tumors who may benefit from treatment with KEYTRUDA® (pembrolizumab).", + "curated": true, + "genetic": false, + "note": null, + "associations": [ + { + "id": 57, + "name": null, + "associationCancerTypes": [ + { + "id": 76, + "relation": "INCLUSION", + "cancerType": { + "id": 3, + "code": "ALL_SOLID_TUMORS", + "color": "MIXED", + "level": -1, + "mainType": "All Solid Tumors", + "subtype": null, + "tissue": "MIXED", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 13127, + "type": "NA", + "name": "Microsatellite Instability-High", + "alteration": "MSI-H", + "proteinChange": "MSI-H", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 42082, + "entrezGeneId": -2, + "hugoSymbol": "Other Biomarkers", + "hgncId": null, + "evidences": null + } + ], + "consequence": { + "id": 39, + "term": "UNKNOWN", + "name": "Unknown", + "isGenerallyTruncating": false, + "description": "Unknown status", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 65, + "name": null, + "drugs": [ + { + "id": 84, + "uuid": "0746dd92-8f4d-4bf7-9161-57a223cb67d5", + "name": "Pembrolizumab" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + }, + { + "id": 32, + "number": "P170019", + "supplementNumber": "S030", + "deviceName": "FoundationOne CDx (F1CDx)", + "genericName": "Next generation sequencing oncology panel, somatic or germline variant detection system", + "dateReceived": "2021-07-01T00:00:00Z", + "decisionDate": "2022-01-19T00:00:00Z", + "description": "Approval to expand the intended use of FoundationOne CDx (F1CDx) to expand the intended use of FoundationOne CDx (F1CDx) to include a companion diagnostic indication for identifying patients with BRAF V600 mutation-positive unresectable or metastatic melanoma, who may benefit from treatment with atezolizumab (Tecentriq) in combination with cobimetinib and vemurafenib.", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 58, + "name": null, + "associationCancerTypes": [ + { + "id": 77, + "relation": "INCLUSION", + "cancerType": { + "id": 172, + "code": "MEL", + "color": "Black", + "level": 2, + "mainType": "Melanoma", + "subtype": "Melanoma", + "tissue": "Skin", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 1391, + "type": "PROTEIN_CHANGE", + "name": "V600", + "alteration": "V600", + "proteinChange": "V600", + "start": 600, + "end": 600, + "refResidues": "V", + "variantResidues": "", + "genes": [ + { + "id": 41259, + "entrezGeneId": 673, + "hugoSymbol": "BRAF", + "hgncId": "1097", + "evidences": null + } + ], + "consequence": { + "id": 17, + "term": "NA", + "name": "NA", + "isGenerallyTruncating": false, + "description": "NA", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 66, + "name": null, + "drugs": [ + { + "id": 4, + "uuid": "4e91da20-6cf0-4e07-995f-7f7db4c7c077", + "name": "Vemurafenib" + }, + { + "id": 45, + "uuid": "9a54c73a-15d8-41a8-8ea0-730f874831da", + "name": "Atezolizumab" + }, + { + "id": 47, + "uuid": "eb357145-3b18-4aca-b75a-5e18dd2bf4f9", + "name": "Cobimetinib" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. 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This database may be searched by a variety of fields and is updated once a week." + } + } + ], + "specimenTypes": [ + { + "id": 3, + "type": "FFPE", + "name": "FFPE" + } + ] + }, + { + "id": 13, + "name": "FoundationOne Liquid CDx ", + "manufacturer": "Foundation Medicine, Inc.", + "indicationDetails": null, + "platformType": "NGS", + "lastUpdated": "2024-01-11T17:01:07.767242Z", + "fdaSubmissions": [ + { + "id": 37, + "number": "P190032", + "supplementNumber": "S005", + "deviceName": "FoundationOne Liquid CDx (F1 Liquid CDx)", + "genericName": "Next generation sequencing oncology panel, somatic or germline variant detection system", + "dateReceived": "2022-08-15T00:00:00Z", + "decisionDate": "2023-05-03T00:00:00Z", + "description": "Approval to include a companion diagnostic indication for EGFR exon 20 insertions in patients with non-small cell lung cancer who may benefit from treatment with EXKIVITY® (mobocertinib).", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 67, + "name": null, + "associationCancerTypes": [ + { + "id": 90, + "relation": "INCLUSION", + "cancerType": { + "id": 64, + "code": "NSCLC", + "color": "Gainsboro", + "level": 2, + "mainType": "Non-Small Cell Lung Cancer", + "subtype": "Non-Small Cell Lung Cancer", + "tissue": "Lung", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 5243, + "type": "PROTEIN_CHANGE", + "name": "Exon 20 in-frame insertions", + "alteration": "762_823ins", + "proteinChange": "762_823ins", + "start": 762, + "end": 823, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 12, + "term": "INFRAME_INSERTION", + "name": "Inframe Insertion", + "isGenerallyTruncating": false, + "description": "An inframe non synonymous variant that inserts bases into in the coding sequence", + "categoricalAlterations": null + } + }, + { + "id": 5244, + "type": "PROTEIN_CHANGE", + "name": "Exon 20 in-frame insertions", + "alteration": "762_823ins {excluding A763_Y764insFQEA}", + "proteinChange": "762_823ins", + "start": 762, + "end": 823, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 12, + "term": "INFRAME_INSERTION", + "name": "Inframe Insertion", + "isGenerallyTruncating": false, + "description": "An inframe non synonymous variant that inserts bases into in the coding sequence", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 75, + "name": null, + "drugs": [ + { + "id": 66, + "uuid": "3de4c502-6c5e-4c10-93b6-f67976c56213", + "name": "Mobocertinib" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + }, + { + "id": 38, + "number": "P190032", + "supplementNumber": "", + "deviceName": "FoundationOne Liquid CDx (F1 Liquid CDx)", + "genericName": "Next generation sequencing oncology panel, somatic or germline variant detection system", + "dateReceived": "2019-12-26T00:00:00Z", + "decisionDate": "2020-08-26T00:00:00Z", + "description": "Approval for the FoundationOne® Liquid CDx. The device is a qualitative next generation sequencing based in vitro diagnostic test that uses targeted high throughput hybridization-based capture technology to detect and report substitutions, insertions and deletions (indels) in 311 genes, including rearrangements and copy number losses only in BRCA1 and BRCA2. FoundationOne® Liquid CDx utilizes circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of cancer patients collected in FoundationOne® Liquid CDx cfDNA blood collection tubes included in the FoundationOne® Liquid CDx Blood Sample Collection Kit. The test is intended to be used as a companion diagnostic to identify patients who may benefit from treatment with the targeted therapies listed in Table 1 in accordance with the approved therapeutic product labeling. Additionally, FoundationOne® Liquid CDx is intended to provide tumor mutation profiling for substitutions and indels to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Table 1: Companion diagnostic indicationsTumor Type Biomarker(s) Detected TherapyNon-small cell lung cancer (NSCLC) EGFR exon 19 deletions andEGFR exon 21 L858R alteration IRESSA® (gefitinib)TAGRISSO® (osimertinib)TARCEVA® (erlotinib)Prostate cancer BRCA1, BRCA2 alterations RUBRACA® (rucaparib)A negative result from a plasma specimen does not mean that the patient’s tumor is negative for genomic findings. Patients who are negative for the mutations listed in Table 1 should be reflexed to routine biopsy and their tumor mutation status confirmed using an FDA-approved tumor tissue test, if feasible.Genomic findings other than those listed in Table 1 are not prescriptive or conclusive for labeled use of any specific therapeutic product. 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"relation": "INCLUSION", + "cancerType": { + "id": 3, + "code": "ALL_SOLID_TUMORS", + "color": "MIXED", + "level": -1, + "mainType": "All Solid Tumors", + "subtype": null, + "tissue": "MIXED", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 13070, + "type": "STRUCTURAL_VARIANT", + "name": "Fusions", + "alteration": "Fusions", + "proteinChange": "", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 39108, + "entrezGeneId": 4916, + "hugoSymbol": "NTRK3", + "hgncId": "8033", + "evidences": null + } + ], + "consequence": { + "id": 39, + "term": "UNKNOWN", + "name": "Unknown", + "isGenerallyTruncating": false, + "description": "Unknown status", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 85, + "name": null, + "drugs": [ + { + "id": 133, + "uuid": "2371f7f5-6407-4a4b-b951-a0f786355455", + "name": "Entrectinib" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + }, + { + "id": 42, + "number": "P200006", + "supplementNumber": "", + "deviceName": "FoundationOne Liquid CDx (F1 Liquid CDx)", + "genericName": "Next generation sequencing oncology panel, somatic or germline variant detection system", + "dateReceived": "2020-02-03T00:00:00Z", + "decisionDate": "2020-10-26T00:00:00Z", + "description": "Approval for FoundationOne® Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test that uses targeted high throughput hybridization-based capture technology to detect and report substitutions, insertions and deletions (indels) in 311 genes, including rearrangements in three (3) genes, and copy number alterations in three (3) genes. FoundationOne® Liquid CDx utilizes circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of cancer patients collected in FoundationOne® Liquid CDx cfDNA blood collection tubes included in the FoundationOne® Liquid CDx Blood Sample Collection Kit. The test is intended to be used as a companion diagnostic to identify patients who may benefit from treatment with the targeted therapies listed in table 1 in accordance with the approved therapeutic product labeling.Table 1: Companion diagnostic indicationsTumor Type Biomarker(s) Detected TherapyNon-small cell lung cancer (NSCLC) EGFR Exon 19 deletions andEGFR Exon 21 L858R alteration IRESSA® (gefitinib)TAGRISSO® (osimertinib)TARCEVA® (erlotinib) ALK Rearrangements ALECENSA® (alectinib)Prostate cancer BRCA1, BRCA2 alterations RUBRACA® (rucaparib)Ovarian Cancer BRCA1, BRCA2 alterations RUBRACA® (rucaparib)Breast Cancer PIK3CA mutations C420R, E542K, E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R, H1047L, H1047R, and H1047Y PIQRAY® (alpelisib)Additionally, FoundationOne® Liquid CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms.A negative result from a plasma specimen does not mean that the patient’s tumor is negative for genomic findings. Patients who are negative for the mutations listed in Table 1 should be reflexed to routine biopsy and their tumor mutation status confirmed using an FDA-approved tumor tissue test, if feasible.Genomic findings other than those listed in Table 1 of the intended use statement are not prescriptive or conclusive for labeled use of any specific therapeutic product. FoundationOne® Liquid CDx is a single-site assay performed at Foundation Medicine, Inc. in Cambridge, MA.", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 78, + "name": null, + "associationCancerTypes": [ + { + "id": 103, + "relation": "INCLUSION", + "cancerType": { + "id": 64, + "code": "NSCLC", + "color": "Gainsboro", + "level": 2, + "mainType": "Non-Small Cell Lung Cancer", + "subtype": "Non-Small Cell Lung Cancer", + "tissue": "Lung", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 559, + "type": "STRUCTURAL_VARIANT", + "name": "Fusions", + "alteration": "Fusions", + "proteinChange": "", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 21832, + "entrezGeneId": 238, + "hugoSymbol": "ALK", + "hgncId": "427", + "evidences": null + } + ], + "consequence": { + "id": 39, + "term": "UNKNOWN", + "name": "Unknown", + "isGenerallyTruncating": false, + "description": "Unknown status", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 86, + "name": null, + "drugs": [ + { + "id": 98, + "uuid": "ef2bee25-4fa3-40c4-a79f-4f885377afa7", + "name": "Alectinib" + } + ] + } + ] + }, + { + "id": 79, + "name": null, + "associationCancerTypes": [ + { + "id": 104, + "relation": "INCLUSION", + "cancerType": { + "id": 978, + "code": null, + "color": "HotPink", + "level": 0, + "mainType": "Breast Cancer", + "subtype": null, + "tissue": "Breast", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 13431, + "type": "PROTEIN_CHANGE", + "name": "E545K", + "alteration": "E545K", + "proteinChange": "E545K", + "start": 545, + "end": 545, + "refResidues": "E", + "variantResidues": "K", + "genes": [ + { + "id": 39934, + "entrezGeneId": 5290, + "hugoSymbol": "PIK3CA", + "hgncId": "8975", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 13426, + "type": "PROTEIN_CHANGE", + "name": "C420R", + "alteration": "C420R", + "proteinChange": "C420R", + "start": 420, + "end": 420, + "refResidues": "C", + "variantResidues": "R", + "genes": [ + { + "id": 39934, + "entrezGeneId": 5290, + "hugoSymbol": "PIK3CA", + "hgncId": "8975", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 13427, + "type": "PROTEIN_CHANGE", + "name": "E542K", + "alteration": "E542K", + "proteinChange": "E542K", + "start": 542, + "end": 542, + "refResidues": "E", + "variantResidues": "K", + "genes": [ + { + "id": 39934, + "entrezGeneId": 5290, + "hugoSymbol": "PIK3CA", + "hgncId": "8975", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 13428, + "type": "PROTEIN_CHANGE", + "name": "E545A", + "alteration": "E545A", + "proteinChange": "E545A", + "start": 545, + "end": 545, + "refResidues": "E", + "variantResidues": "A", + "genes": [ + { + "id": 39934, + "entrezGeneId": 5290, + "hugoSymbol": "PIK3CA", + "hgncId": "8975", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 13429, + "type": "PROTEIN_CHANGE", + "name": "E545D", + "alteration": "E545D", + "proteinChange": "E545D", + "start": 545, + "end": 545, + "refResidues": "E", + "variantResidues": "D", + "genes": [ + { + "id": 39934, + "entrezGeneId": 5290, + "hugoSymbol": "PIK3CA", + "hgncId": "8975", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 13430, + "type": "PROTEIN_CHANGE", + "name": "E545G", + "alteration": "E545G", + "proteinChange": "E545G", + "start": 545, + "end": 545, + "refResidues": "E", + "variantResidues": "G", + "genes": [ + { + "id": 39934, + "entrezGeneId": 5290, + "hugoSymbol": "PIK3CA", + "hgncId": "8975", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 13432, + "type": "PROTEIN_CHANGE", + "name": "Q546E", + "alteration": "Q546E", + "proteinChange": "Q546E", + "start": 546, + "end": 546, + "refResidues": "Q", + "variantResidues": "E", + "genes": [ + { + "id": 39934, + "entrezGeneId": 5290, + "hugoSymbol": "PIK3CA", + "hgncId": "8975", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 13433, + "type": "PROTEIN_CHANGE", + "name": "Q546R", + "alteration": "Q546R", + "proteinChange": "Q546R", + "start": 546, + "end": 546, + "refResidues": "Q", + "variantResidues": "R", + "genes": [ + { + "id": 39934, + "entrezGeneId": 5290, + "hugoSymbol": "PIK3CA", + "hgncId": "8975", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 13434, + "type": "PROTEIN_CHANGE", + "name": "H1047L", + "alteration": "H1047L", + "proteinChange": "H1047L", + "start": 1047, + "end": 1047, + "refResidues": "H", + "variantResidues": "L", + "genes": [ + { + "id": 39934, + "entrezGeneId": 5290, + "hugoSymbol": "PIK3CA", + "hgncId": "8975", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 13435, + "type": "PROTEIN_CHANGE", + "name": "H1047R", + "alteration": "H1047R", + "proteinChange": "H1047R", + "start": 1047, + "end": 1047, + "refResidues": "H", + "variantResidues": "R", + "genes": [ + { + "id": 39934, + "entrezGeneId": 5290, + "hugoSymbol": "PIK3CA", + "hgncId": "8975", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 13436, + "type": "PROTEIN_CHANGE", + "name": "H1047Y", + "alteration": "H1047Y", + "proteinChange": "H1047Y", + "start": 1047, + "end": 1047, + "refResidues": "H", + "variantResidues": "Y", + "genes": [ + { + "id": 39934, + "entrezGeneId": 5290, + "hugoSymbol": "PIK3CA", + "hgncId": "8975", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 87, + "name": null, + "drugs": [ + { + "id": 32, + "uuid": "b25af9e9-2195-4f16-90ea-7c21fcf3882d", + "name": "Fulvestrant" + }, + { + "id": 83, + "uuid": "d76cc0eb-d098-4133-95a5-5f59fad65f80", + "name": "Alpelisib" + } + ] + } + ] + }, + { + "id": 80, + "name": null, + "associationCancerTypes": [ + { + "id": 105, + "relation": "INCLUSION", + "cancerType": { + "id": 935, + "code": null, + "color": "Cyan", + "level": 0, + "mainType": "Prostate Cancer, NOS", + "subtype": null, + "tissue": "Prostate", + "tumorForm": "SOLID" + } + }, + { + "id": 106, + "relation": "INCLUSION", + "cancerType": { + "id": 987, + "code": null, + "color": "Cyan", + "level": 0, + "mainType": "Prostate Cancer", + "subtype": null, + "tissue": "Prostate", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 1951, + "type": "PROTEIN_CHANGE", + "name": "Oncogenic Mutations", + "alteration": "Oncogenic Mutations", + "proteinChange": "Oncogenic Mutations", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 41258, + "entrezGeneId": 672, + "hugoSymbol": "BRCA1", + "hgncId": "1100", + "evidences": null + } + ], + "consequence": { + "id": 39, + "term": "UNKNOWN", + "name": "Unknown", + "isGenerallyTruncating": false, + "description": "Unknown status", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 88, + "name": null, + "drugs": [ + { + "id": 145, + "uuid": "578af76a-2e8a-463a-b7bd-0494c91ad2a1", + "name": "Olaparib" + } + ] + } + ] + }, + { + "id": 81, + "name": null, + "associationCancerTypes": [ + { + "id": 107, + "relation": "INCLUSION", + "cancerType": { + "id": 935, + "code": null, + "color": "Cyan", + "level": 0, + "mainType": "Prostate Cancer, NOS", + "subtype": null, + "tissue": "Prostate", + "tumorForm": "SOLID" + } + }, + { + "id": 108, + "relation": "INCLUSION", + "cancerType": { + "id": 987, + "code": null, + "color": "Cyan", + "level": 0, + "mainType": "Prostate Cancer", + "subtype": null, + "tissue": "Prostate", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 2574, + "type": "PROTEIN_CHANGE", + "name": "Oncogenic Mutations", + "alteration": "Oncogenic Mutations", + "proteinChange": "Oncogenic Mutations", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 32518, + "entrezGeneId": 675, + "hugoSymbol": "BRCA2", + "hgncId": "1101", + "evidences": null + } + ], + "consequence": { + "id": 39, + "term": "UNKNOWN", + "name": "Unknown", + "isGenerallyTruncating": false, + "description": "Unknown status", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 89, + "name": null, + "drugs": [ + { + "id": 145, + "uuid": "578af76a-2e8a-463a-b7bd-0494c91ad2a1", + "name": "Olaparib" + } + ] + } + ] + }, + { + "id": 82, + "name": null, + "associationCancerTypes": [ + { + "id": 109, + "relation": "INCLUSION", + "cancerType": { + "id": 935, + "code": null, + "color": "Cyan", + "level": 0, + "mainType": "Prostate Cancer, NOS", + "subtype": null, + "tissue": "Prostate", + "tumorForm": "SOLID" + } + }, + { + "id": 110, + "relation": "INCLUSION", + "cancerType": { + "id": 987, + "code": null, + "color": "Cyan", + "level": 0, + "mainType": "Prostate Cancer", + "subtype": null, + "tissue": "Prostate", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 885, + "type": "PROTEIN_CHANGE", + "name": "Oncogenic Mutations", + "alteration": "Oncogenic Mutations", + "proteinChange": "Oncogenic Mutations", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 23673, + "entrezGeneId": 472, + "hugoSymbol": "ATM", + "hgncId": "795", + "evidences": null + } + ], + "consequence": { + "id": 39, + "term": "UNKNOWN", + "name": "Unknown", + "isGenerallyTruncating": false, + "description": "Unknown status", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 90, + "name": null, + "drugs": [ + { + "id": 145, + "uuid": "578af76a-2e8a-463a-b7bd-0494c91ad2a1", + "name": "Olaparib" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + }, + { + "id": 43, + "number": "P190032", + "supplementNumber": "S010", + "deviceName": "FoundationOne Liquid CDx (F1 Liquid CDx)", + "genericName": "Next generation sequencing oncology panel, somatic or germline variant detection system", + "dateReceived": "2022-11-22T00:00:00Z", + "decisionDate": "2023-06-08T00:00:00Z", + "description": "Approval for the FoundationOne Liquid CDx (F1 Liquid CDx). The device expands the indications for use to include a companion diagnostic indication for the detection of BRAF V600E alteration in patients with metastatic colorectal cancer (CRC) who may benefit from treatment with BRAFTOVI® (encorafenib) in combination with cetuximab. ", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 83, + "name": null, + "associationCancerTypes": [ + { + "id": 111, + "relation": "INCLUSION", + "cancerType": { + "id": 874, + "code": null, + "color": "SaddleBrown", + "level": 0, + "mainType": "Colorectal Cancer", + "subtype": null, + "tissue": "Bowel", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 1388, + "type": "PROTEIN_CHANGE", + "name": "V600E", + "alteration": "V600E", + "proteinChange": "V600E", + "start": 600, + "end": 600, + "refResidues": "V", + "variantResidues": "E", + "genes": [ + { + "id": 41259, + "entrezGeneId": 673, + "hugoSymbol": "BRAF", + "hgncId": "1097", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 91, + "name": null, + "drugs": [ + { + "id": 117, + "uuid": "001e534f-3e63-432f-90a6-d1af1759e4e2", + "name": "Encorafenib" + }, + { + "id": 123, + "uuid": "5fce3074-e420-4c36-9603-2423daf20118", + "name": "Cetuximab" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + } + ], + "specimenTypes": [ + { + "id": 1, + "type": "CFDNA", + "name": "cfDNA from plasma" + } + ] + }, + { + "id": 14, + "name": "Guardant360 CDx ", + "manufacturer": "Guardant Health, Inc.", + "indicationDetails": null, + "platformType": "NGS", + "lastUpdated": "2024-01-11T17:01:10.899676Z", + "fdaSubmissions": [ + { + "id": 44, + "number": "P200010", + "supplementNumber": "", + "deviceName": "Guardant360 CDx", + "genericName": "Next generation sequencing oncology panel, somatic or germline variant detection system", + "dateReceived": "2020-02-10T00:00:00Z", + "decisionDate": "2020-08-07T00:00:00Z", + "description": "Approval order for Guardant360® CDx. Guardant360® CDx is a qualitative next generation sequencing-based in vitro diagnostic device that uses targeted high throughput hybridization-based capture technology for detection of single nucleotide variants (SNVs), insertions and deletions (indels) in 55 genes, copy number amplifications (CNAs) in two (2) genes, and fusions in four (4) genes. Guardant360 CDx utilizes circulating cell-free DNA (cfDNA) from plasma of peripheral whole blood collected in Streck Cell-Free DNA Blood Collection Tubes (BCTs). The test is intended to be used as a companion diagnostic to identify non-small cell lung cancer (NSCLC) patients who may benefit from treatment with the targeted therapy listed in Table 1 in accordance with the approved therapeutic product labeling. Table 1. Companion Diagnostic IndicationsIndication: Non-small cell lung cancer (NSCLC); Biomarker: EGFR exon 19 deletions, L858R, and T790M*; Therapy: TAGRISSO® (osimertinib)A negative result from a plasma specimen does not assure that the patient’s tumor is negative for genomic findings. NSCLC patients who are negative for the biomarkers listed in Table 1 should be reflexed to tissue biopsy testing for Table 1 biomarkers using an FDA-approved tumor tissue test, if feasible.*The efficacy of TAGRISSO® (osimertinib) has not been established in the EGFR T790M plasma-positive, tissue-negative or unknown population and clinical data for T790M plasma-positive patients are limited; therefore, testing using plasma specimens is most appropriate for consideration in patients from whom a tumor biopsy cannot be obtained.Additionally, the test is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for cancer patients with solid malignant neoplasms. The test is for use with patients previously diagnosed with cancer and in conjunction with other laboratory and clinical findings. Genomic findings other than those listed in Table 1 are not prescriptive or conclusive for labeled use of any specific therapeutic product. Guardant360 CDx is a single-site assay performed at Guardant Health, Inc.", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 84, + "name": null, + "associationCancerTypes": [ + { + "id": 112, + "relation": "INCLUSION", + "cancerType": { + "id": 64, + "code": "NSCLC", + "color": "Gainsboro", + "level": 2, + "mainType": "Non-Small Cell Lung Cancer", + "subtype": "Non-Small Cell Lung Cancer", + "tissue": "Lung", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 5023, + "type": "PROTEIN_CHANGE", + "name": "L858R", + "alteration": "L858R", + "proteinChange": "L858R", + "start": 858, + "end": 858, + "refResidues": "L", + "variantResidues": "R", + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 5025, + "type": "PROTEIN_CHANGE", + "name": "T790M", + "alteration": "T790M", + "proteinChange": "T790M", + "start": 790, + "end": 790, + "refResidues": "T", + "variantResidues": "M", + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 5027, + "type": "PROTEIN_CHANGE", + "name": "Exon 19 in-frame deletions", + "alteration": "729_761del", + "proteinChange": "729_761del", + "start": 729, + "end": 761, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 11, + "term": "INFRAME_DELETION", + "name": "Inframe Deletion", + "isGenerallyTruncating": false, + "description": "An inframe non synonymous variant that deletes bases from the coding sequence", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 92, + "name": null, + "drugs": [ + { + "id": 72, + "uuid": "4c2c1261-bfc3-4180-8113-127194366320", + "name": "Osimertinib" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + }, + { + "id": 45, + "number": "P200010", + "supplementNumber": "S001", + "deviceName": "Guardant360 CDx", + "genericName": "Next generation sequencing oncology panel, somatic or germline variant detection system", + "dateReceived": "2020-11-20T00:00:00Z", + "decisionDate": "2021-05-21T00:00:00Z", + "description": "Approval order for extending the label claim to include an indication for RYBREVANT (amivantamab) in non-small cell lung cancer patients with EGFR exon 20 insertions.", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 85, + "name": null, + "associationCancerTypes": [ + { + "id": 113, + "relation": "INCLUSION", + "cancerType": { + "id": 64, + "code": "NSCLC", + "color": "Gainsboro", + "level": 2, + "mainType": "Non-Small Cell Lung Cancer", + "subtype": "Non-Small Cell Lung Cancer", + "tissue": "Lung", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 5243, + "type": "PROTEIN_CHANGE", + "name": "Exon 20 in-frame insertions", + "alteration": "762_823ins", + "proteinChange": "762_823ins", + "start": 762, + "end": 823, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 12, + "term": "INFRAME_INSERTION", + "name": "Inframe Insertion", + "isGenerallyTruncating": false, + "description": "An inframe non synonymous variant that inserts bases into in the coding sequence", + "categoricalAlterations": null + } + }, + { + "id": 5244, + "type": "PROTEIN_CHANGE", + "name": "Exon 20 in-frame insertions", + "alteration": "762_823ins {excluding A763_Y764insFQEA}", + "proteinChange": "762_823ins", + "start": 762, + "end": 823, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 12, + "term": "INFRAME_INSERTION", + "name": "Inframe Insertion", + "isGenerallyTruncating": false, + "description": "An inframe non synonymous variant that inserts bases into in the coding sequence", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 93, + "name": null, + "drugs": [ + { + "id": 53, + "uuid": "5079a0fa-8b3a-41c5-9b03-9216f0044057", + "name": "Amivantamab" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + }, + { + "id": 46, + "number": "P200010", + "supplementNumber": "S002", + "deviceName": "Guardant360 CDx", + "genericName": "Next generation sequencing oncology panel, somatic or germline variant detection system", + "dateReceived": "2020-12-18T00:00:00Z", + "decisionDate": "2021-05-28T00:00:00Z", + "description": "Approval of Guardant360 CDx for expanding the indications for use to include the companion diagnostic claim to identify non-small cell lung cancer patients with KRAS G12C mutation for treatment with LUMAKRASTM (sotorasib). ", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 86, + "name": null, + "associationCancerTypes": [ + { + "id": 114, + "relation": "INCLUSION", + "cancerType": { + "id": 64, + "code": "NSCLC", + "color": "Gainsboro", + "level": 2, + "mainType": "Non-Small Cell Lung Cancer", + "subtype": "Non-Small Cell Lung Cancer", + "tissue": "Lung", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 10208, + "type": "PROTEIN_CHANGE", + "name": "G12C", + "alteration": "G12C", + "proteinChange": "G12C", + "start": 12, + "end": 12, + "refResidues": "G", + "variantResidues": "C", + "genes": [ + { + "id": 30480, + "entrezGeneId": 3845, + "hugoSymbol": "KRAS", + "hgncId": "6407", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 94, + "name": null, + "drugs": [ + { + "id": 17, + "uuid": "7d507726-ed2e-4f65-a35a-0e1e88984278", + "name": "Sotorasib" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + }, + { + "id": 47, + "number": "P200010", + "supplementNumber": "S008", + "deviceName": "Guardant360 CDx", + "genericName": "Next generation sequencing oncology panel, somatic or germline variant detection system", + "dateReceived": "2022-04-13T00:00:00Z", + "decisionDate": "2022-08-11T00:00:00Z", + "description": "Approval for expanding the indications for use to include the companion diagnostic claim to identify non-small cell lung cancer patients with ERBB2 activating mutations (SNVs and exon 20 insertions) for treatment with ENHERTU (fam-trastuzumab deruxtecan-nxki).", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 87, + "name": null, + "associationCancerTypes": [ + { + "id": 115, + "relation": "INCLUSION", + "cancerType": { + "id": 64, + "code": "NSCLC", + "color": "Gainsboro", + "level": 2, + "mainType": "Non-Small Cell Lung Cancer", + "subtype": "Non-Small Cell Lung Cancer", + "tissue": "Lung", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 6078, + "type": "PROTEIN_CHANGE", + "name": "Oncogenic Mutations", + "alteration": "Oncogenic Mutations", + "proteinChange": "Oncogenic Mutations", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 7677, + "entrezGeneId": 2064, + "hugoSymbol": "ERBB2", + "hgncId": "3430", + "evidences": null + } + ], + "consequence": { + "id": 39, + "term": "UNKNOWN", + "name": "Unknown", + "isGenerallyTruncating": false, + "description": "Unknown status", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 95, + "name": null, + "drugs": [ + { + "id": 85, + "uuid": "37dd10c7-69c0-4d63-a171-8cb2570c1a54", + "name": "Trastuzumab Deruxtecan" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + }, + { + "id": 48, + "number": "P200010", + "supplementNumber": "S010", + "deviceName": "Guardant360 CDx", + "genericName": "Next generation sequencing oncology panel, somatic or germline variant detection system", + "dateReceived": "2022-06-21T00:00:00Z", + "decisionDate": "2023-01-27T00:00:00Z", + "description": "Approval for expanding the indications for use to include the companion diagnostic claim to identify breast cancer patients with ESR1 missense mutations between codons 310-547 for treatment with ORSERDU (elacestrant).", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 88, + "name": null, + "associationCancerTypes": [ + { + "id": 116, + "relation": "INCLUSION", + "cancerType": { + "id": 978, + "code": null, + "color": "HotPink", + "level": 0, + "mainType": "Breast Cancer", + "subtype": null, + "tissue": "Breast", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 7547, + "type": "PROTEIN_CHANGE", + "name": "S463P", + "alteration": "S463P", + "proteinChange": "S463P", + "start": 463, + "end": 463, + "refResidues": "S", + "variantResidues": "P", + "genes": [ + { + "id": 24657, + "entrezGeneId": 2099, + "hugoSymbol": "ESR1", + "hgncId": "3467", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 7550, + "type": "PROTEIN_CHANGE", + "name": "L469V", + "alteration": "L469V", + "proteinChange": "L469V", + "start": 469, + "end": 469, + "refResidues": "L", + "variantResidues": "V", + "genes": [ + { + "id": 24657, + "entrezGeneId": 2099, + "hugoSymbol": "ESR1", + "hgncId": "3467", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 7561, + "type": "PROTEIN_CHANGE", + "name": "D538", + "alteration": "D538", + "proteinChange": "D538", + "start": 538, + "end": 538, + "refResidues": "D", + "variantResidues": "", + "genes": [ + { + "id": 24657, + "entrezGeneId": 2099, + "hugoSymbol": "ESR1", + "hgncId": "3467", + "evidences": null + } + ], + "consequence": { + "id": 17, + "term": "NA", + "name": "NA", + "isGenerallyTruncating": false, + "description": "NA", + "categoricalAlterations": null + } + }, + { + "id": 7562, + "type": "PROTEIN_CHANGE", + "name": "E380", + "alteration": "E380", + "proteinChange": "E380", + "start": 380, + "end": 380, + "refResidues": "E", + "variantResidues": "", + "genes": [ + { + "id": 24657, + "entrezGeneId": 2099, + "hugoSymbol": "ESR1", + "hgncId": "3467", + "evidences": null + } + ], + "consequence": { + "id": 17, + "term": "NA", + "name": "NA", + "isGenerallyTruncating": false, + "description": "NA", + "categoricalAlterations": null + } + }, + { + "id": 7563, + "type": "PROTEIN_CHANGE", + "name": "Y537", + "alteration": "Y537", + "proteinChange": "Y537", + "start": 537, + "end": 537, + "refResidues": "Y", + "variantResidues": "", + "genes": [ + { + "id": 24657, + "entrezGeneId": 2099, + "hugoSymbol": "ESR1", + "hgncId": "3467", + "evidences": null + } + ], + "consequence": { + "id": 17, + "term": "NA", + "name": "NA", + "isGenerallyTruncating": false, + "description": "NA", + "categoricalAlterations": null + } + }, + { + "id": 7564, + "type": "PROTEIN_CHANGE", + "name": "L536", + "alteration": "L536", + "proteinChange": "L536", + "start": 536, + "end": 536, + "refResidues": "L", + "variantResidues": "", + "genes": [ + { + "id": 24657, + "entrezGeneId": 2099, + "hugoSymbol": "ESR1", + "hgncId": "3467", + "evidences": null + } + ], + "consequence": { + "id": 17, + "term": "NA", + "name": "NA", + "isGenerallyTruncating": false, + "description": "NA", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 96, + "name": null, + "drugs": [ + { + "id": 57, + "uuid": "011f81cc-06a0-45d5-b2c1-22052afa7cd6", + "name": "Elacestrant" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + } + ], + "specimenTypes": [ + { + "id": 1, + "type": "CFDNA", + "name": "cfDNA from plasma" + } + ] + }, + { + "id": 15, + "name": "HER2 CISH pharmDx Kit ", + "manufacturer": "Dako Denmark A/S", + "indicationDetails": null, + "platformType": "CISH", + "lastUpdated": "2024-01-11T17:01:11.326058Z", + "fdaSubmissions": [ + { + "id": 49, + "number": "P100024", + "supplementNumber": "", + "deviceName": "HER2 CISH PHARMDX KIT", + "genericName": "Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer", + "dateReceived": "2010-06-21T00:00:00Z", + "decisionDate": "2011-11-30T00:00:00Z", + "description": "APPROVAL FOR THE HER2 CISH PHARMDX KIT. THIS DEVICE IS INDICATED TOR;HER2 CISH PHARMDX KIT IS INTENDED FOR DUAL-COLOR CHROMOGENIC VISUALIZATION OF SIGNALS ACHIEVED WITH DIRECTLY LABELED IN SITU HYBRIDIZATION PROBES TARGETING THE HER2 GENE AND CENTROMERIC REGION OF CHROMOSOME 17. THE KIT IS DESIGNED TO QUANTITATIVELY DETERMINE HER2 GENE STATUS IN FORMALIN-FIXED, PARAFFIN-EMBEDDED BREAST CANCER TISSUE SPECIMENS. RED AND BLUE CHROMOGENIC SIGNALS ARE GENERATED ON THE SAME TISSUE SECTION FOR EVALUATION UNDER BRIGHT FIELD MICROSCOPY. THE CISH PROCEDURE IS AUTOMATED USING DAKO AUTOSLAINERINSTRUMENTS. HER2 CISH PHARMDX KIT IS INDICATED AS AN AID IN THE ASSESSMENT OF PATIENTS FOR WHOM HERCEPTIN (TRASTUZUMAB) TREATMENT IS BEING CONSIDERED. RESULTS FROM THE HER2 CISH PHARMDX KIT ARE INTENDED FOR USE AS AN ADJUNCT TO THE CLINICOPATHOLOGIC INFORMATIONCURRENTLY USED FOR ESTIMATING PROGNOSIS IN STAGE II, NODE-POSITIVE BREAST CANCER PATIENTS.", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 89, + "name": null, + "associationCancerTypes": [ + { + "id": 117, + "relation": "INCLUSION", + "cancerType": { + "id": 978, + "code": null, + "color": "HotPink", + "level": 0, + "mainType": "Breast Cancer", + "subtype": null, + "tissue": "Breast", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 6079, + "type": "COPY_NUMBER_ALTERATION", + "name": "Amplification", + "alteration": "Amplification", + "proteinChange": "", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 7677, + "entrezGeneId": 2064, + "hugoSymbol": "ERBB2", + "hgncId": "3430", + "evidences": null + } + ], + "consequence": { + "id": 39, + "term": "UNKNOWN", + "name": "Unknown", + "isGenerallyTruncating": false, + "description": "Unknown status", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 97, + "name": null, + "drugs": [ + { + "id": 38, + "uuid": "b29b3641-d866-4b09-bff6-3063d8316935", + "name": "Trastuzumab" + } + ] + }, + { + "id": 98, + "name": null, + "drugs": [ + { + "id": 38, + "uuid": "b29b3641-d866-4b09-bff6-3063d8316935", + "name": "Trastuzumab" + }, + { + "id": 103, + "uuid": "3bbe37b1-edc8-4c54-93f8-5360d9a83d69", + "name": "Chemotherapy" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + } + ], + "specimenTypes": [ + { + "id": 3, + "type": "FFPE", + "name": "FFPE" + } + ] + }, + { + "id": 16, + "name": "HER2 FISH pharmDx Kit ", + "manufacturer": "Dako Denmark A/S", + "indicationDetails": null, + "platformType": "FISH", + "lastUpdated": "2024-01-11T17:01:13.364216Z", + "fdaSubmissions": [ + { + "id": 50, + "number": "P040005", + "supplementNumber": "", + "deviceName": "DAKOCYTOMATION HER2 FISH PHARMDX KIT", + "genericName": "SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM", + "dateReceived": "2004-01-29T00:00:00Z", + "decisionDate": "2005-05-03T00:00:00Z", + "description": "APPROVAL FOR THE DAKOCYTOMATION HER2 FISH PHARMDX KIT. THE DEVICE IS INDICATED FOR: THE DAKOCYTOMATION HER2 FISH PHARMDX KIT IS A DIRECT FLUORESCENCE IN SITU HYBRIDIZATION (FISH) ASSAY DESIGNED TO QUANTITATIVELY DETERMINE THE HER2 GENE AMPLIFICATION IN FORMALIN-FIXED, PARAFFIN-EMBEDDED BREAST CANCER TISSUE SPECIMENS. HER2 FISH PHARMDX KIT IS INDICATED AS AN AID IN THE ASSESSMENT OF PATIENTS FOR WHOM HERCEPTIN (TRASTUZUMAB) TREATMENT IS BEING CONSIDERED. RESULTS FORM THE HER2 FISH PHARMDX KIT ARE INTENDED FOR USE AS AN ADJUNCT TO THE CLINICOPATHOLOGIC INFORMATION CURRENTLY USED FOR ESTIMATING PROGNOSIS IN STAGE II, NODE POSITIVE BREAST CANCER PATIENTS.", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 90, + "name": null, + "associationCancerTypes": [ + { + "id": 118, + "relation": "INCLUSION", + "cancerType": { + "id": 978, + "code": null, + "color": "HotPink", + "level": 0, + "mainType": "Breast Cancer", + "subtype": null, + "tissue": "Breast", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 6079, + "type": "COPY_NUMBER_ALTERATION", + "name": "Amplification", + "alteration": "Amplification", + "proteinChange": "", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 7677, + "entrezGeneId": 2064, + "hugoSymbol": "ERBB2", + "hgncId": "3430", + "evidences": null + } + ], + "consequence": { + "id": 39, + "term": "UNKNOWN", + "name": "Unknown", + "isGenerallyTruncating": false, + "description": "Unknown status", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 99, + "name": null, + "drugs": [ + { + "id": 38, + "uuid": "b29b3641-d866-4b09-bff6-3063d8316935", + "name": "Trastuzumab" + } + ] + }, + { + "id": 100, + "name": null, + "drugs": [ + { + "id": 38, + "uuid": "b29b3641-d866-4b09-bff6-3063d8316935", + "name": "Trastuzumab" + }, + { + "id": 103, + "uuid": "3bbe37b1-edc8-4c54-93f8-5360d9a83d69", + "name": "Chemotherapy" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + }, + { + "id": 51, + "number": "P040005", + "supplementNumber": "S005", + "deviceName": "HER2 FISH PHARMDX KIT", + "genericName": "SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM", + "dateReceived": "2010-04-20T00:00:00Z", + "decisionDate": "2010-10-20T00:00:00Z", + "description": "APPROVAL FOR THE HER2 FISH PHARMDX KIT. THE DEVICE IS INDICATED FOR IN VITRO DIAGNOSTIC USE. THE HER2 FISH PHARMDX KIT IS A DIRECT FLUORESCENCE IN SITU HYBRIDIZATION (FISH) ASSAY DESIGNED TO QUANTITATIVELY DETERMINE HER2 GENE AMPLIFICATION IN FORMALIN-FIXED, PARAFFIN-EMBEDDED (FFPE) BREAST CANCER TISSUE SPECIMENS AND FFPE SPECIMENS FROM PATIENTS WITH METASTATIC GASTRIC OR GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA. HER2 FISH PHARMDX KIT IS INDICATED AS AN AID IN THE ASSESSMENT OF PATIENTS FOR WHOM HERCEPTIN (TRASTUZUMAB) TREATMENT IS BEING CONSIDERED (SEE HERCEPTIN PACKAGE INSERT).", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 91, + "name": null, + "associationCancerTypes": [ + { + "id": 119, + "relation": "INCLUSION", + "cancerType": { + "id": 967, + "code": null, + "color": "LightSkyBlue", + "level": 0, + "mainType": "Esophagogastric Cancer", + "subtype": null, + "tissue": "Esophagus/Stomach", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 6079, + "type": "COPY_NUMBER_ALTERATION", + "name": "Amplification", + "alteration": "Amplification", + "proteinChange": "", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 7677, + "entrezGeneId": 2064, + "hugoSymbol": "ERBB2", + "hgncId": "3430", + "evidences": null + } + ], + "consequence": { + "id": 39, + "term": "UNKNOWN", + "name": "Unknown", + "isGenerallyTruncating": false, + "description": "Unknown status", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 101, + "name": null, + "drugs": [ + { + "id": 38, + "uuid": "b29b3641-d866-4b09-bff6-3063d8316935", + "name": "Trastuzumab" + }, + { + "id": 84, + "uuid": "0746dd92-8f4d-4bf7-9161-57a223cb67d5", + "name": "Pembrolizumab" + }, + { + "id": 103, + "uuid": "3bbe37b1-edc8-4c54-93f8-5360d9a83d69", + "name": "Chemotherapy" + } + ] + }, + { + "id": 102, + "name": null, + "drugs": [ + { + "id": 38, + "uuid": "b29b3641-d866-4b09-bff6-3063d8316935", + "name": "Trastuzumab" + }, + { + "id": 103, + "uuid": "3bbe37b1-edc8-4c54-93f8-5360d9a83d69", + "name": "Chemotherapy" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + }, + { + "id": 52, + "number": "P040005", + "supplementNumber": "S006", + "deviceName": "HER2 FISH PHARMADX KIT", + "genericName": "SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM", + "dateReceived": "2011-12-05T00:00:00Z", + "decisionDate": "2012-06-08T00:00:00Z", + "description": "APPROVAL FOR ADDITION OF PERTUZUMAB IN THE LABELING OF HER2 FISH PHARMDX KIT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HER2 FISH PHARMDX KIT AND ITS INDICATION FOR USE IS: A DIRECT FLUORESCENCE IN SITU HYBRIDIZATION (FISH) ASSAY DESIGNED TOQUANTITATIVELY DETERMINE HER2 GENE AMPLIFICATION IN FORMALIN-FIXED, PARAFFIN-EMBEDDED (FFPE) BREAST CANCER TISSUE SPECIMENS AND FFPE SPECIMENS FROM PATIENTS WITH METASTATIC GASTRIC OR GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA. HER2 FISH PHARMDX KIT IS INDICATED AS AN AID IN THE ASSESSMENT OF BREAST AND GASTRIC CANCER PATIENTS FOR WHOM HERCEPTIN (TRASTUZUMAB) TREATMENT IS BEING CONSIDERED AND FOR BREAST CANCER PATIENTS FOR WHOM PERJETA (PERTUZUMAB) TREATMENT IS BEING CONSIDERED (SEE HERCEPTIN AND PERJETA PACKAGE INSERTS).", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 92, + "name": null, + "associationCancerTypes": [ + { + "id": 120, + "relation": "INCLUSION", + "cancerType": { + "id": 978, + "code": null, + "color": "HotPink", + "level": 0, + "mainType": "Breast Cancer", + "subtype": null, + "tissue": "Breast", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 6079, + "type": "COPY_NUMBER_ALTERATION", + "name": "Amplification", + "alteration": "Amplification", + "proteinChange": "", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 7677, + "entrezGeneId": 2064, + "hugoSymbol": "ERBB2", + "hgncId": "3430", + "evidences": null + } + ], + "consequence": { + "id": 39, + "term": "UNKNOWN", + "name": "Unknown", + "isGenerallyTruncating": false, + "description": "Unknown status", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 103, + "name": null, + "drugs": [ + { + "id": 38, + "uuid": "b29b3641-d866-4b09-bff6-3063d8316935", + "name": "Trastuzumab" + }, + { + "id": 103, + "uuid": "3bbe37b1-edc8-4c54-93f8-5360d9a83d69", + "name": "Chemotherapy" + }, + { + "id": 148, + "uuid": "b89a5c78-1828-4adf-a9fa-937f99410c1d", + "name": "Pertuzumab" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + }, + { + "id": 53, + "number": "P040005", + "supplementNumber": "S009", + "deviceName": "HER2 FISH PHARMADX KIT", + "genericName": "SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM", + "dateReceived": "2012-08-24T00:00:00Z", + "decisionDate": "2013-02-22T00:00:00Z", + "description": "APPROVAL FOR ADDITION OF KADCYLA (ADO-TRASTUZUMAB EMTANSINE) IN THE LABELING OF HER2 IQ-FISH PHARMDX KIT.", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 93, + "name": null, + "associationCancerTypes": [ + { + "id": 121, + "relation": "INCLUSION", + "cancerType": { + "id": 978, + "code": null, + "color": "HotPink", + "level": 0, + "mainType": "Breast Cancer", + "subtype": null, + "tissue": "Breast", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 6079, + "type": "COPY_NUMBER_ALTERATION", + "name": "Amplification", + "alteration": "Amplification", + "proteinChange": "", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 7677, + "entrezGeneId": 2064, + "hugoSymbol": "ERBB2", + "hgncId": "3430", + "evidences": null + } + ], + "consequence": { + "id": 39, + "term": "UNKNOWN", + "name": "Unknown", + "isGenerallyTruncating": false, + "description": "Unknown status", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 104, + "name": null, + "drugs": [ + { + "id": 7, + "uuid": "598e7b9f-976d-46bc-aea7-42f1005db988", + "name": "Ado-Trastuzumab Emtansine" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + } + ], + "specimenTypes": [ + { + "id": 3, + "type": "FFPE", + "name": "FFPE" + } + ] + }, + { + "id": 17, + "name": "INFORM HER-2/neu ", + "manufacturer": "Ventana Medical Systems, Inc.", + "indicationDetails": null, + "platformType": "FISH", + "lastUpdated": "2024-01-11T17:01:13.729155Z", + "fdaSubmissions": [ + { + "id": 54, + "number": "P940004", + "supplementNumber": "", + "deviceName": "ONCOR(R) AMPLITECT(TM) HER/NEU(ERBB2)GENE AMPLIFI", + "genericName": "SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM", + "dateReceived": "1994-02-14T00:00:00Z", + "decisionDate": "1997-12-30T00:00:00Z", + "description": "Approval for the Oncor(R) Inform(TM) HER-2/neu Gene Detection System. The Oncor(R) INFORM(TM) HER-2/neu Gene Detection System is a fluorescence in situ hybridization (FISH) DNA probe assay that determines the qualitative presence of HER-2/neu gene amplification on formalin-fixed, paraffin-embedded human breast tissue as an aid to stratify breast cancer patients according to risk for recurrence or disease-related death. It is indicated for use as an adjunct to existing clinical and pathologic information currently used as prognostic indicators in the risk stratification of breast cancer in patients who have had a priary, invasive, localized breast carcinoma and who are lymph node-negative.", + "curated": true, + "genetic": false, + "note": null, + "associations": [ + { + "id": 94, + "name": null, + "associationCancerTypes": [ + { + "id": 122, + "relation": "INCLUSION", + "cancerType": { + "id": 978, + "code": null, + "color": "HotPink", + "level": 0, + "mainType": "Breast Cancer", + "subtype": null, + "tissue": "Breast", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 6079, + "type": "COPY_NUMBER_ALTERATION", + "name": "Amplification", + "alteration": "Amplification", + "proteinChange": "", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 7677, + "entrezGeneId": 2064, + "hugoSymbol": "ERBB2", + "hgncId": "3430", + "evidences": null + } + ], + "consequence": { + "id": 39, + "term": "UNKNOWN", + "name": "Unknown", + "isGenerallyTruncating": false, + "description": "Unknown status", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 105, + "name": null, + "drugs": [ + { + "id": 38, + "uuid": "b29b3641-d866-4b09-bff6-3063d8316935", + "name": "Trastuzumab" + } + ] + }, + { + "id": 106, + "name": null, + "drugs": [ + { + "id": 38, + "uuid": "b29b3641-d866-4b09-bff6-3063d8316935", + "name": "Trastuzumab" + }, + { + "id": 103, + "uuid": "3bbe37b1-edc8-4c54-93f8-5360d9a83d69", + "name": "Chemotherapy" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + } + ], + "specimenTypes": [ + { + "id": 3, + "type": "FFPE", + "name": "FFPE" + } + ] + }, + { + "id": 18, + "name": "INFORM HER2 Dual ISH DNA Probe Cocktail ", + "manufacturer": "Ventana Medical Systems, Inc.", + "indicationDetails": null, + "platformType": "CISH", + "lastUpdated": "2024-01-11T17:01:14.685653Z", + "fdaSubmissions": [ + { + "id": 55, + "number": "P100027", + "supplementNumber": "", + "deviceName": "INFORM HER2 DUAL ISH DNA PROBE COCKTAIL", + "genericName": "Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer", + "dateReceived": "2010-07-12T00:00:00Z", + "decisionDate": "2011-06-14T00:00:00Z", + "description": "APPROVAL FOR THE INFORM HER2 DUAL ISH DNA PROBE COCKTAIL. THIS DEVICE IS INDICATED FOR:THE INFORM HER2 DUAL ISH DNA PROBE COCKTAIL IS INTENDED FOR USE IN DETERMINING HER2 GENE STATUS BY ENUMERATION OF THE RATIO OF THE HER2 GENE TO CHROMOSOME 17. THE HER2 AND CHROMOSOME 17 PROBES ARE DETECTED USING TWO COLOR CHROMOGENIC IN SITU HYBRIDIZATION (ISH) IN FORMALIN-FIXED. PARAFFIN-EMBEDDED HUMAN BREAST CANCER TISSUE SPECIMENS FOLLOWING STAINING ON VENTANA BENCHMARK XT AUTOMATED SLIDE STAINERS (USING NEXES SOFTWARE), BY LIGHT MICROSCOPY. THE INFORM HER2 DUAL ISH DNA PROBE COCKTAIL IS INDICATED AS AN AID IN THE ASSESSMENT OF PATIENTS FOR WHOM I-HERPCEPTIN (TRASTUZUMAB) TREATMENT IS BEING CONSIDERED.THIS PRODUCT SHOULD BE INTERPRETED BY A QUALIFIED READER IN CONJUNCTION WITH HISTOLOGICAL EXAMINATION, RELEVANT CLINICAL INFORMATION, AND PROPER CONTROLS.THIS REAGENT IS INTENDED FOR IN VITRO DIAGNOSTIC (IVD) USE.", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 95, + "name": null, + "associationCancerTypes": [ + { + "id": 123, + "relation": "INCLUSION", + "cancerType": { + "id": 978, + "code": null, + "color": "HotPink", + "level": 0, + "mainType": "Breast Cancer", + "subtype": null, + "tissue": "Breast", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 6079, + "type": "COPY_NUMBER_ALTERATION", + "name": "Amplification", + "alteration": "Amplification", + "proteinChange": "", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 7677, + "entrezGeneId": 2064, + "hugoSymbol": "ERBB2", + "hgncId": "3430", + "evidences": null + } + ], + "consequence": { + "id": 39, + "term": "UNKNOWN", + "name": "Unknown", + "isGenerallyTruncating": false, + "description": "Unknown status", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 107, + "name": null, + "drugs": [ + { + "id": 38, + "uuid": "b29b3641-d866-4b09-bff6-3063d8316935", + "name": "Trastuzumab" + } + ] + }, + { + "id": 108, + "name": null, + "drugs": [ + { + "id": 38, + "uuid": "b29b3641-d866-4b09-bff6-3063d8316935", + "name": "Trastuzumab" + }, + { + "id": 103, + "uuid": "3bbe37b1-edc8-4c54-93f8-5360d9a83d69", + "name": "Chemotherapy" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + }, + { + "id": 56, + "number": "P100027", + "supplementNumber": "S030", + "deviceName": "INFORM HER2 Dual ISH DNA Probe Cocktail assays", + "genericName": "Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer", + "dateReceived": "2019-02-13T00:00:00Z", + "decisionDate": "2019-05-03T00:00:00Z", + "description": "Approval for the Ventana Medical Systems, Inc’s (Ventana) INFORM HER2 Dual ISH DNA Probe Cocktail is intended to determine HER2 gene status by enumeration of the ratio of the HER2 gene to Chromosome 17. The HER2 and Chromosome 17 probes are detected by light microscopy using two color chromogenic in situ hybridization (ISH) in formalin-fixed, paraffin-embedded human breast cancer tissue specimens following staining on a BenchMark XT or BenchMark ULTRA instrument. The INFORM HER2 Dual ISH DNA Probe Cocktail is indicated as an aid in the assessment of breast cancer patients for whom Herceptin® (trastuzumab) or KADCYLA® (ado-trastuzumab emtansine) treatment is being considered. This product should be interpreted by a qualified reader in conjunction with histological examination, relevant clinical information, and proper controls.This reagent is intended for in vitro diagnostic (IVD) use.", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 96, + "name": null, + "associationCancerTypes": [ + { + "id": 124, + "relation": "INCLUSION", + "cancerType": { + "id": 978, + "code": null, + "color": "HotPink", + "level": 0, + "mainType": "Breast Cancer", + "subtype": null, + "tissue": "Breast", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 6079, + "type": "COPY_NUMBER_ALTERATION", + "name": "Amplification", + "alteration": "Amplification", + "proteinChange": "", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 7677, + "entrezGeneId": 2064, + "hugoSymbol": "ERBB2", + "hgncId": "3430", + "evidences": null + } + ], + "consequence": { + "id": 39, + "term": "UNKNOWN", + "name": "Unknown", + "isGenerallyTruncating": false, + "description": "Unknown status", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 109, + "name": null, + "drugs": [ + { + "id": 7, + "uuid": "598e7b9f-976d-46bc-aea7-42f1005db988", + "name": "Ado-Trastuzumab Emtansine" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + } + ], + "specimenTypes": [ + { + "id": 3, + "type": "FFPE", + "name": "FFPE" + } + ] + }, + { + "id": 19, + "name": "InSite Her-2/neu (CB11) Monoclonal Antibody ", + "manufacturer": "Biogenex Laboratories, Inc.", + "indicationDetails": null, + "platformType": "IHC", + "lastUpdated": "2024-01-11T17:01:15.445914Z", + "fdaSubmissions": [ + { + "id": 57, + "number": "P040030", + "supplementNumber": "", + "deviceName": "INSITE HER-2/NEU KIT", + "genericName": "SYSTEM, TEST, HER-2/NEU, IHC", + "dateReceived": "2004-06-22T00:00:00Z", + "decisionDate": "2004-12-22T00:00:00Z", + "description": "APPROVAL FOR THE INSITE HER-2/NEU KIT. THE DEVICE IS INDICATED FOR: INSITE HER-2/NEU MOUSE MONOCLONAL ANTIBODY (CLONE CB11) KIT IS INTENDED FOR IN VITRO DIAGNOSTIC USE IN IMMUNOHISTOCHEM-ISTRY (IHC) ASSAYS TO SEMI-QUANTITATIVELY LOCALIZED BY LIGHT MICROSCOPY THE OVER-EXPRESSION OF HER-2/NEU (I.E., C-ERBB-2) IN FORMALIN-FIXED, PARAFFIN-EMBEDDED NORMAL AND NEOPLASTIC TISSUE SECTIONS. INSITE HER-2/NEU IS INDICATED AS AN AID IN THE ASSESSMENT OF BREAST CANCER PATIENTS FOR WHOM HERCEPTIN (TRASTUZUMAB) THERAPY IS BEING CONSIDERED. CLINICAL INTERPRETATION OF INSITE HER-2/NEU IMMUNOSTAINING RESULTS (ABSENCE OR PRESENCE; SEMI-QUANTITATIVE INTENSITY SCORE) SHOULD BE COMPLEMENTED BY APPROPRIATE CONTROLS AND MORPHOLOGICAL TISSUE ANALYSIS AND BE EVALUATED BY A QUALIFIED PATHOLOGIST WITHIN THE CONTEXT OF PATIENT CLINICAL HISTORY AND OTHER DIAGNOSTIC RESULTS.", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 97, + "name": null, + "associationCancerTypes": [ + { + "id": 125, + "relation": "INCLUSION", + "cancerType": { + "id": 978, + "code": null, + "color": "HotPink", + "level": 0, + "mainType": "Breast Cancer", + "subtype": null, + "tissue": "Breast", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 6079, + "type": "COPY_NUMBER_ALTERATION", + "name": "Amplification", + "alteration": "Amplification", + "proteinChange": "", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 7677, + "entrezGeneId": 2064, + "hugoSymbol": "ERBB2", + "hgncId": "3430", + "evidences": null + } + ], + "consequence": { + "id": 39, + "term": "UNKNOWN", + "name": "Unknown", + "isGenerallyTruncating": false, + "description": "Unknown status", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 110, + "name": null, + "drugs": [ + { + "id": 38, + "uuid": "b29b3641-d866-4b09-bff6-3063d8316935", + "name": "Trastuzumab" + } + ] + }, + { + "id": 111, + "name": null, + "drugs": [ + { + "id": 38, + "uuid": "b29b3641-d866-4b09-bff6-3063d8316935", + "name": "Trastuzumab" + }, + { + "id": 103, + "uuid": "3bbe37b1-edc8-4c54-93f8-5360d9a83d69", + "name": "Chemotherapy" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + } + ], + "specimenTypes": [ + { + "id": 3, + "type": "FFPE", + "name": "FFPE" + } + ] + }, + { + "id": 20, + "name": "KIT D816V Assay ", + "manufacturer": "ARUP Laboratories, Inc.", + "indicationDetails": null, + "platformType": "PCR", + "lastUpdated": "2024-01-11T17:01:15.906343Z", + "fdaSubmissions": [ + { + "id": 58, + "number": "H140006", + "supplementNumber": "", + "deviceName": "KIT D816V ASSAY", + "genericName": "somatic gene mutation detection system", + "dateReceived": "2014-11-26T00:00:00Z", + "decisionDate": "2015-12-18T00:00:00Z", + "description": "Approval for the kit d816v mutation detection by pcr for gleevec eligibility in aggressive systemic mastocytosis (asm). 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The LeukoStrat® CDx FLT3 Mutation Assay is used as an aid in the selection of patients with AML for whom RYDAPT (midostaurin) treatment is being considered. The Leukostrat® CDx FLT3 Mutation Assay is to be performed only at Laboratory for Personalized Molecular Medicine (LabPMM) LLC, a single site laboratory located at 6330 Nancy Ridge Dr., San Diego, CA 92121.", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 99, + "name": null, + "associationCancerTypes": [ + { + "id": 127, + "relation": "INCLUSION", + "cancerType": { + "id": 476, + "code": "AML", + "color": "LightSalmon", + "level": 3, + "mainType": "Leukemia", + "subtype": "Acute Myeloid Leukemia", + "tissue": "Myeloid", + "tumorForm": "LIQUID" + } + } + ], + "alterations": [ + { + "id": 8705, + "type": "PROTEIN_CHANGE", + "name": "Internal tandem duplication", + "alteration": "572_630ins", + "proteinChange": "572_630ins", + "start": 572, + "end": 630, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 20903, + "entrezGeneId": 2322, + "hugoSymbol": "FLT3", + "hgncId": "3765", + "evidences": null + } + ], + "consequence": { + "id": 12, + "term": "INFRAME_INSERTION", + "name": "Inframe Insertion", + "isGenerallyTruncating": false, + "description": "An inframe non synonymous variant that inserts bases into in the coding sequence", + "categoricalAlterations": null + } + }, + { + "id": 8706, + "type": "PROTEIN_CHANGE", + "name": "D835", + "alteration": "D835", + "proteinChange": "D835", + "start": 835, + "end": 835, + "refResidues": "D", + "variantResidues": "", + "genes": [ + { + "id": 20903, + "entrezGeneId": 2322, + "hugoSymbol": "FLT3", + "hgncId": "3765", + "evidences": null + } + ], + "consequence": { + "id": 17, + "term": "NA", + "name": "NA", + "isGenerallyTruncating": false, + "description": "NA", + "categoricalAlterations": null + } + }, + { + "id": 8707, + "type": "PROTEIN_CHANGE", + "name": "I836", + "alteration": "I836", + "proteinChange": "I836", + "start": 836, + "end": 836, + "refResidues": "I", + "variantResidues": "", + "genes": [ + { + "id": 20903, + "entrezGeneId": 2322, + "hugoSymbol": "FLT3", + "hgncId": "3765", + "evidences": null + } + ], + "consequence": { + "id": 17, + "term": "NA", + "name": "NA", + "isGenerallyTruncating": false, + "description": "NA", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 113, + "name": null, + "drugs": [ + { + "id": 131, + "uuid": "b4012b4d-f7a5-49d9-9101-a4e1de203e9e", + "name": "Midostaurin" + }, + { + "id": 147, + "uuid": "faef6994-b7f8-4845-9f10-8eab19d7cb86", + "name": "High Dose Chemotherapy" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. 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An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + }, + { + "id": 61, + "number": "P160040", + "supplementNumber": "S011", + "deviceName": "LeukoStrat CDx FLT3 Mutation Assay", + "genericName": "Somatic gene mutation detection system", + "dateReceived": "2022-08-25T00:00:00Z", + "decisionDate": "2023-07-20T00:00:00Z", + "description": "Approval for the LeukoStrat CDx FLT3 Mutation Assay. 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An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + } + ], + "specimenTypes": [ + { + "id": 5, + "type": "MONO_CELLS_BONE_MARROW", + "name": "Mononuclear cells from bone marrow" + }, + { + "id": 6, + "type": "MONO_CELLS_PERIF_BLOOD", + "name": "Mononuclear cells from peripheral blood" + } + ] + }, + { + "id": 22, + "name": "MRDx BCR-ABL Test ", + "manufacturer": "MolecularMD Corporation", + "indicationDetails": null, + "platformType": "PCR", + "lastUpdated": "2024-01-11T17:01:17.504051Z", + "fdaSubmissions": [ + { + "id": 62, + "number": "K173492", + "supplementNumber": "", + "deviceName": "MRDx BCR-ABL Test, MRDx BCR-ABL Test Software", + "genericName": null, + "dateReceived": "2017-11-13T00:00:00Z", + "decisionDate": "2017-12-22T00:00:00Z", + "description": null, + "curated": true, + "genetic": false, + "note": null, + "associations": [ + { + "id": 102, + "name": null, + "associationCancerTypes": [ + { + "id": 130, + "relation": "INCLUSION", + "cancerType": { + "id": 685, + "code": "CML", + "color": "LightSalmon", + "level": 4, + "mainType": "Myeloproliferative Neoplasms", + "subtype": "Chronic Myelogenous Leukemia", + "tissue": "Myeloid", + "tumorForm": "LIQUID" + } + } + ], + "alterations": [ + { + "id": 2, + "type": "STRUCTURAL_VARIANT", + "name": "BCR-ABL1 Fusion", + "alteration": "BCR-ABL1 Fusion", + "proteinChange": "", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 27789, + "entrezGeneId": 25, + "hugoSymbol": "ABL1", + "hgncId": "76", + "evidences": null + } + ], + "consequence": { + "id": 39, + "term": "UNKNOWN", + "name": "Unknown", + "isGenerallyTruncating": false, + "description": "Unknown status", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 116, + "name": null, + "drugs": [ + { + "id": 110, + "uuid": "0f991d49-4cf2-4975-b52f-d7d037aa7f11", + "name": "Nilotinib" + } + ] + } + ] + } + ], + "type": { + "id": 4, + "type": "PMN", + "name": "Premarket Notifications (510(k)s)", + "shortName": "510(k)", + "description": "Medical device manufacturers are required to submit a premarket notification or 510(k) if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. This database of releasable 510(k)s can be searched by 510(k) number, applicant, device name or FDA product code. Summaries of safety and effectiveness information is available via the web interface for more recent records. The database is updated once a week." + } + } + ], + "specimenTypes": [ + { + "id": 7, + "type": "PERIF_BLOOD", + "name": "Peripheral Blood" + } + ] + }, + { + "id": 23, + "name": "Myriad myChoice CDx ", + "manufacturer": "Myriad Genetic Laboratories, Inc.", + "indicationDetails": null, + "platformType": "NGS", + "lastUpdated": "2024-01-11T17:01:17.933425Z", + "fdaSubmissions": [ + { + "id": 63, + "number": "P190014", + "supplementNumber": "S003", + "deviceName": "myChoice CDx", + "genericName": "Next generation sequencing oncology panel, somatic or germline variant detection system", + "dateReceived": "2020-02-11T00:00:00Z", + "decisionDate": "2020-05-08T00:00:00Z", + "description": "Approval for Myriad myChoice® CDx to include a companion diagnostic indication for homologous recombination deficiency (HRD) in ovarian cancer patients who may benefit from maintenance treatment with Lynparza® (olaparib)\".", + "curated": true, + "genetic": false, + "note": null, + "associations": [ + { + "id": 103, + "name": null, + "associationCancerTypes": [ + { + "id": 131, + "relation": "INCLUSION", + "cancerType": { + "id": 910, + "code": null, + "color": "LightBlue", + "level": 0, + "mainType": "Ovarian Cancer", + "subtype": null, + "tissue": "Ovary/Fallopian Tube", + "tumorForm": "SOLID" + } + }, + { + "id": 132, + "relation": "INCLUSION", + "cancerType": { + "id": 28, + "code": "OVARY", + "color": "LightBlue", + "level": 1, + "mainType": "Ovarian/Fallopian Tube Cancer, NOS", + "subtype": "Ovary/Fallopian Tube", + "tissue": "Ovary/Fallopian Tube", + "tumorForm": "SOLID" + } + }, + { + "id": 133, + "relation": "INCLUSION", + "cancerType": { + "id": 270, + "code": "PSEC", + "color": "Green", + "level": 2, + "mainType": "Peritoneal Cancer, NOS", + "subtype": "Peritoneal Serous Carcinoma", + "tissue": "Peritoneum", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 1951, + "type": "PROTEIN_CHANGE", + "name": "Oncogenic Mutations", + "alteration": "Oncogenic Mutations", + "proteinChange": "Oncogenic Mutations", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 41258, + "entrezGeneId": 672, + "hugoSymbol": "BRCA1", + "hgncId": "1100", + "evidences": null + } + ], + "consequence": { + "id": 39, + "term": "UNKNOWN", + "name": "Unknown", + "isGenerallyTruncating": false, + "description": "Unknown status", + "categoricalAlterations": null + } + }, + { + "id": 2574, + "type": "PROTEIN_CHANGE", + "name": "Oncogenic Mutations", + "alteration": "Oncogenic Mutations", + "proteinChange": "Oncogenic Mutations", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 32518, + "entrezGeneId": 675, + "hugoSymbol": "BRCA2", + "hgncId": "1101", + "evidences": null + } + ], + "consequence": { + "id": 39, + "term": "UNKNOWN", + "name": "Unknown", + "isGenerallyTruncating": false, + "description": "Unknown status", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 117, + "name": null, + "drugs": [ + { + "id": 145, + "uuid": "578af76a-2e8a-463a-b7bd-0494c91ad2a1", + "name": "Olaparib" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + } + ], + "specimenTypes": [ + { + "id": 3, + "type": "FFPE", + "name": "FFPE" + } + ] + }, + { + "id": 24, + "name": "ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA) ", + "manufacturer": "Pillar Biosciences, Inc.", + "indicationDetails": null, + "platformType": "NGS", + "lastUpdated": "2024-01-11T17:01:18.780352Z", + "fdaSubmissions": [ + { + "id": 64, + "number": "P200011", + "supplementNumber": "", + "deviceName": "ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA)", + "genericName": "Next generation sequencing oncology panel, somatic or germline variant detection system", + "dateReceived": "2020-02-18T00:00:00Z", + "decisionDate": "2021-07-30T00:00:00Z", + "description": "Approval of the ONCO/RevealTM Dx Lung and Colon Cancer Assay (O/RDx-LCCA). The device is a qualitative next generation sequencing based in vitro diagnostic test that uses amplicon-based target enrichment technology for detection of single nucleotide variants (SNVs) and deletions in 2 genes from DNA isolated from formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) tumor tissue specimens. The test is intended as a companion diagnostic to identify patients with NSCLC or CRC who may benefit from treatment with the targeted therapies listed in Table 1 in accordance with the approved therapeutic product labeling. The O/RDx-LCCA is intended to be used on the Illumina MiSeqDx® instrument.Table 1. List of somatic variants for therapeutic useIndication Gene Variant Targeted therapyColorectal Cancer (CRC) KRAS KRAS wild-type (absence of mutations in codons 12 and 13) ERBITUX® (cetuximab), orVECTIBIX® (panitumumab)Non-Small Cell Lung Cancer(NSCLC) EGFR Exon 19 Deletions and Exon 21 L858R Substitution Mutations EGFR Tyrosine Kinase Inhibitors approved by FDA**For the most current information about the therapeutic products in this group, go to: https://www.fda.gov/medicaldevices/productsandmedicalprocedures/invitrodiagnostics/ucm301431.htm ", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 104, + "name": null, + "associationCancerTypes": [ + { + "id": 134, + "relation": "INCLUSION", + "cancerType": { + "id": 874, + "code": null, + "color": "SaddleBrown", + "level": 0, + "mainType": "Colorectal Cancer", + "subtype": null, + "tissue": "Bowel", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 10204, + "type": "NA", + "name": "Wildtype", + "alteration": "Wildtype", + "proteinChange": "", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 30480, + "entrezGeneId": 3845, + "hugoSymbol": "KRAS", + "hgncId": "6407", + "evidences": null + } + ], + "consequence": { + "id": 3, + "term": "ANY", + "name": "Any", + "isGenerallyTruncating": false, + "description": "Any variant", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 118, + "name": null, + "drugs": [ + { + "id": 123, + "uuid": "5fce3074-e420-4c36-9603-2423daf20118", + "name": "Cetuximab" + } + ] + }, + { + "id": 119, + "name": null, + "drugs": [ + { + "id": 103, + "uuid": "3bbe37b1-edc8-4c54-93f8-5360d9a83d69", + "name": "Chemotherapy" + }, + { + "id": 123, + "uuid": "5fce3074-e420-4c36-9603-2423daf20118", + "name": "Cetuximab" + } + ] + } + ] + }, + { + "id": 105, + "name": null, + "associationCancerTypes": [ + { + "id": 135, + "relation": "INCLUSION", + "cancerType": { + "id": 874, + "code": null, + "color": "SaddleBrown", + "level": 0, + "mainType": "Colorectal Cancer", + "subtype": null, + "tissue": "Bowel", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 10204, + "type": "NA", + "name": "Wildtype", + "alteration": "Wildtype", + "proteinChange": "", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 30480, + "entrezGeneId": 3845, + "hugoSymbol": "KRAS", + "hgncId": "6407", + "evidences": null + } + ], + "consequence": { + "id": 3, + "term": "ANY", + "name": "Any", + "isGenerallyTruncating": false, + "description": "Any variant", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 120, + "name": null, + "drugs": [ + { + "id": 65, + "uuid": "d7b1d12a-e942-4801-bb64-916c9bdfaaf3", + "name": "Panitumumab" + } + ] + }, + { + "id": 121, + "name": null, + "drugs": [ + { + "id": 65, + "uuid": "d7b1d12a-e942-4801-bb64-916c9bdfaaf3", + "name": "Panitumumab" + }, + { + "id": 103, + "uuid": "3bbe37b1-edc8-4c54-93f8-5360d9a83d69", + "name": "Chemotherapy" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + } + ], + "specimenTypes": [ + { + "id": 3, + "type": "FFPE", + "name": "FFPE" + } + ] + }, + { + "id": 25, + "name": "Oncomine Dx Target Test ", + "manufacturer": "Life Technologies Corporation", + "indicationDetails": null, + "platformType": "NGS", + "lastUpdated": "2024-01-11T17:01:23.868012Z", + "fdaSubmissions": [ + { + "id": 65, + "number": "P160045", + "supplementNumber": "", + "deviceName": "Oncomine Dx Target Test", + "genericName": "Next generation sequencing oncology panel, somatic or germline variant detection system", + "dateReceived": "2016-10-17T00:00:00Z", + "decisionDate": "2017-06-22T00:00:00Z", + "description": "Approval for the The Oncomine Dx Target Test is a qualitative in vitro diagnostic test that uses targeted high throughput, parallel-sequencing technology to detect single nucleotide variants (SNVs) and deletions in 23 genes from DNA and fusions in ROS1 from RNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples from patients with non-small cell lung cancer (NSCLC) using the Ion PGM Dx System. The test is indicated to aid in selecting NSCLC patients for treatment with the targeted therapies listed in Table 1 in accordance with the approved therapeutic product labeling.Table 1. List of variants for therapeutic useGene Variant Targeted therapyBRAF BRAF V600E TAFINLAR® (dabrafenib) in combination with MEKINIST® (trametinib)ROS1 ROS1 fusions XALKORI® (crizotinib)EGFR L858R, Exon 19 deletions IRESSA® (gefitinib)Safe and effective use has not been established for selecting therapies using this device for the variants in Table 1 in tissue types other than NSCLC.Results other than those listed in Table 1 are indicated for use only in patients who have already been considered for all appropriate therapies (including those listed in Table 1). Analytical performance using NSCLC specimens has been established for the variants listed in Table 2.Table 2. List of variants with established analytical performance onlyGene Variant ID Nucleotide changeKRAS COSM512 c.34_35delGGinsTTKRAS COSM516 c.34G>TMET COSM707 c.3029C>TPIK3CA COSM754 c.1035T>AThe test is not indicated to be used for standalone diagnostic purposes, screening, monitoring, risk assessment, or prognosis.", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 106, + "name": null, + "associationCancerTypes": [ + { + "id": 136, + "relation": "INCLUSION", + "cancerType": { + "id": 64, + "code": "NSCLC", + "color": "Gainsboro", + "level": 2, + "mainType": "Non-Small Cell Lung Cancer", + "subtype": "Non-Small Cell Lung Cancer", + "tissue": "Lung", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 1388, + "type": "PROTEIN_CHANGE", + "name": "V600E", + "alteration": "V600E", + "proteinChange": "V600E", + "start": 600, + "end": 600, + "refResidues": "V", + "variantResidues": "E", + "genes": [ + { + "id": 41259, + "entrezGeneId": 673, + "hugoSymbol": "BRAF", + "hgncId": "1097", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 122, + "name": null, + "drugs": [ + { + "id": 15, + "uuid": "939cd40b-b515-499d-b099-fd29027c0d17", + "name": "Dabrafenib" + }, + { + "id": 122, + "uuid": "fb2bb01c-c0ec-4641-abf7-87f486075022", + "name": "Trametinib" + } + ] + } + ] + }, + { + "id": 107, + "name": null, + "associationCancerTypes": [ + { + "id": 137, + "relation": "INCLUSION", + "cancerType": { + "id": 64, + "code": "NSCLC", + "color": "Gainsboro", + "level": 2, + "mainType": "Non-Small Cell Lung Cancer", + "subtype": "Non-Small Cell Lung Cancer", + "tissue": "Lung", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 15858, + "type": "STRUCTURAL_VARIANT", + "name": "Fusions", + "alteration": "Fusions", + "proteinChange": "", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 6685, + "entrezGeneId": 6098, + "hugoSymbol": "ROS1", + "hgncId": "10261", + "evidences": null + } + ], + "consequence": { + "id": 39, + "term": "UNKNOWN", + "name": "Unknown", + "isGenerallyTruncating": false, + "description": "Unknown status", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 123, + "name": null, + "drugs": [ + { + "id": 3, + "uuid": "f05d12ab-6204-4a1c-803f-f3a7f6e30af2", + "name": "Crizotinib" + } + ] + } + ] + }, + { + "id": 108, + "name": null, + "associationCancerTypes": [ + { + "id": 138, + "relation": "INCLUSION", + "cancerType": { + "id": 64, + "code": "NSCLC", + "color": "Gainsboro", + "level": 2, + "mainType": "Non-Small Cell Lung Cancer", + "subtype": "Non-Small Cell Lung Cancer", + "tissue": "Lung", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 5023, + "type": "PROTEIN_CHANGE", + "name": "L858R", + "alteration": "L858R", + "proteinChange": "L858R", + "start": 858, + "end": 858, + "refResidues": "L", + "variantResidues": "R", + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 5027, + "type": "PROTEIN_CHANGE", + "name": "Exon 19 in-frame deletions", + "alteration": "729_761del", + "proteinChange": "729_761del", + "start": 729, + "end": 761, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 11, + "term": "INFRAME_DELETION", + "name": "Inframe Deletion", + "isGenerallyTruncating": false, + "description": "An inframe non synonymous variant that deletes bases from the coding sequence", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 124, + "name": null, + "drugs": [ + { + "id": 33, + "uuid": "b76d7b2b-b5fb-4561-892f-6b00bfaf0dfa", + "name": "Gefitinib" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + }, + { + "id": 66, + "number": "P160045", + "supplementNumber": "S019", + "deviceName": "Oncomine Dx Target Test", + "genericName": null, + "dateReceived": "2020-04-01T00:00:00Z", + "decisionDate": "2020-09-04T00:00:00Z", + "description": "Approval to expand the intended use of the Oncomine Dx Target Test to include a companion diagnostic indication for the detection of RET fusions in non-small cell lung cancer patients who may benefit from treatment with GAVRETO (pralsetinib).", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 109, + "name": null, + "associationCancerTypes": [ + { + "id": 139, + "relation": "INCLUSION", + "cancerType": { + "id": 64, + "code": "NSCLC", + "color": "Gainsboro", + "level": 2, + "mainType": "Non-Small Cell Lung Cancer", + "subtype": "Non-Small Cell Lung Cancer", + "tissue": "Lung", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 15637, + "type": "STRUCTURAL_VARIANT", + "name": "Fusions", + "alteration": "Fusions", + "proteinChange": "", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 5106, + "entrezGeneId": 5979, + "hugoSymbol": "RET", + "hgncId": "9967", + "evidences": null + } + ], + "consequence": { + "id": 39, + "term": "UNKNOWN", + "name": "Unknown", + "isGenerallyTruncating": false, + "description": "Unknown status", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 125, + "name": null, + "drugs": [ + { + "id": 36, + "uuid": "7f9be086-3520-4c28-a414-8d4f3682f920", + "name": "Pralsetinib" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + }, + { + "id": 67, + "number": "P160045", + "supplementNumber": "S027", + "deviceName": "Oncomine™ Dx Target Test", + "genericName": "Next generation sequencing oncology panel, somatic or germline variant detection system", + "dateReceived": "2021-02-22T00:00:00Z", + "decisionDate": "2021-12-01T00:00:00Z", + "description": "Approval to expand the intended use of the Oncomine Dx Target Test to include a companion diagnostic indication for the detection of EGFR exon 20 insertion mutations in non-small cell lung cancer patients who may benefit from treatment with RYBREVANT (amivantamab-vmjw).", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 110, + "name": null, + "associationCancerTypes": [ + { + "id": 140, + "relation": "INCLUSION", + "cancerType": { + "id": 64, + "code": "NSCLC", + "color": "Gainsboro", + "level": 2, + "mainType": "Non-Small Cell Lung Cancer", + "subtype": "Non-Small Cell Lung Cancer", + "tissue": "Lung", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 5243, + "type": "PROTEIN_CHANGE", + "name": "Exon 20 in-frame insertions", + "alteration": "762_823ins", + "proteinChange": "762_823ins", + "start": 762, + "end": 823, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 12, + "term": "INFRAME_INSERTION", + "name": "Inframe Insertion", + "isGenerallyTruncating": false, + "description": "An inframe non synonymous variant that inserts bases into in the coding sequence", + "categoricalAlterations": null + } + }, + { + "id": 5244, + "type": "PROTEIN_CHANGE", + "name": "Exon 20 in-frame insertions", + "alteration": "762_823ins {excluding A763_Y764insFQEA}", + "proteinChange": "762_823ins", + "start": 762, + "end": 823, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 12, + "term": "INFRAME_INSERTION", + "name": "Inframe Insertion", + "isGenerallyTruncating": false, + "description": "An inframe non synonymous variant that inserts bases into in the coding sequence", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 126, + "name": null, + "drugs": [ + { + "id": 53, + "uuid": "5079a0fa-8b3a-41c5-9b03-9216f0044057", + "name": "Amivantamab" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. 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An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + } + ], + "specimenTypes": [ + { + "id": 3, + "type": "FFPE", + "name": "FFPE" + } + ] + }, + { + "id": 28, + "name": "Vysis ALK Break Apart FISH Probe Kit ", + "manufacturer": "Abbott Molecular Inc.", + "indicationDetails": null, + "platformType": "FISH", + "lastUpdated": "2024-01-11T17:01:26.628952Z", + "fdaSubmissions": [ + { + "id": 75, + "number": "P110012", + "supplementNumber": "", + "deviceName": "VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALK", + "genericName": "Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement", + "dateReceived": "2011-04-01T00:00:00Z", + "decisionDate": "2011-08-26T00:00:00Z", + "description": "APPROVAL FOR THE VYSIS ALK BREAK APART FISH PROBE KIT; VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT; PROBECHEK ALK NEGATIVE CONTROL SLIDES; AND PROBECHEK ALK POSITIVE CONTROL SLIDES. THIS DEVICE IS INDICATED FOR: THE VYSIS ALK BREAK APART FISH PROBE KIT IS A QUALITATIVE TEST TO DETECT REARRANGEMENTS INVOLVING THE ALK GENE VIA FLUORESCENCE IN SITU HYBRIDIZATION (FISH) IN FORMALIN-FIXED PARAFFIN -EMBEDDED (FFPE) NON-SMALL CELL LUNG CANCER (NSCLC) TISSUE SPECIMENS TO AID IN IDENTIFYING THOSE PATIENTS ELIGIBLE FOR TREATMENT WITH XALKORI CRIZOTINIB). THE TEST IS FOR PRESCRIPTION USE ONLY. THE VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT IS USED TO PREPARE PARAFFIN-EMBEDDED LUNG CANCER TISSUE SECTIONS FIXED ON POSITIVELY CHARGED SLIDES FOR USE IN FLUORESCENCE IN SITU HYBRIDIZATION (FISH) WITH VYSIS DNA FISH PROBES.THE PROBECHEK ALK NEGATIVE CONTROL SLIDES ARE INTENDED FOR USE AS AN ASSAY CONTROL FOR APPROPRIATE HYBRIDIZATION CONDITIONS DURING ROUTINE USE OF THE VYSIS ALK BREAK APART FISH PROBE KIT (LIST NO. 06N38-020). THE PROBECHEK ALK NEGATIVE CONTROL SLIDES SHOULD BE ASSAYED IN CONJUNCTION WITH THE USER'S SPECIMEN SLIDES ACCORDING THE PACKAGE INSERT FOR THE VYSIS ALK BREAK APART FISH PROBE KIT (LIST NO. 06N38-020). THE PROBECHEK ALK POSITIVE CONTROL SLIDES ARE INTENDED FOR USE AS AN ASSAY CONTROL FOR APPROPRIATE HYBRIDIZATION CONDITIONS DURING ROUTINE USE OF THE VYSIS ALK BREAK APART FISH PROBE KIT (LIST NO. 06N38-020). THE PROBECHEK ALK POSITIVE CONTROL SLIDES SHOULD BE ASSAYED IN CONJUNCTION WITH THE USER'S SPECIMEN SLIDES ACCORDING THE PACKAGE INSERT FOR THE VYSIS ALK BREAK APART FISH PROBE KIT (LIST NO. 06N38-020).", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 119, + "name": null, + "associationCancerTypes": [ + { + "id": 150, + "relation": "INCLUSION", + "cancerType": { + "id": 64, + "code": "NSCLC", + "color": "Gainsboro", + "level": 2, + "mainType": "Non-Small Cell Lung Cancer", + "subtype": "Non-Small Cell Lung Cancer", + "tissue": "Lung", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 559, + "type": "STRUCTURAL_VARIANT", + "name": "Fusions", + "alteration": "Fusions", + "proteinChange": "", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 21832, + "entrezGeneId": 238, + "hugoSymbol": "ALK", + "hgncId": "427", + "evidences": null + } + ], + "consequence": { + "id": 39, + "term": "UNKNOWN", + "name": "Unknown", + "isGenerallyTruncating": false, + "description": "Unknown status", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 137, + "name": null, + "drugs": [ + { + "id": 3, + "uuid": "f05d12ab-6204-4a1c-803f-f3a7f6e30af2", + "name": "Crizotinib" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + }, + { + "id": 76, + "number": "P110012", + "supplementNumber": "S020", + "deviceName": "Vysis ALK Break Apart Fish Probe Kit", + "genericName": "Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement", + "dateReceived": "2019-12-23T00:00:00Z", + "decisionDate": "2020-05-22T00:00:00Z", + "description": "Approval of the expansion of the Indications for Use for the Vysis ALK Break Apart FISH Probe Kit to include an indication for ALUNBRIG® (brigatinib). The device, as modified, will be marketed under the trade name Vysis ALK Break Apart FISH Probe Kit and is indicated for:INTENDED USE The Vysis ALK Break Apart FISH Probe Kit is a qualitative test to detect rearrangements involving the ALK gene via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin-embedded (FFPE) tissue specimens from non-small cell lung cancer (NSCLC) patients.INDICATION FOR USEThe Vysis ALK Break Apart FISH Probe Kit is indicated as an aid in identifying patients eligible for treatment with XALKORI® (crizotinib) and ALUNBRIG® (brigatinib) in accordance with the approved therapeutic product labeling.", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 120, + "name": null, + "associationCancerTypes": [ + { + "id": 151, + "relation": "INCLUSION", + "cancerType": { + "id": 64, + "code": "NSCLC", + "color": "Gainsboro", + "level": 2, + "mainType": "Non-Small Cell Lung Cancer", + "subtype": "Non-Small Cell Lung Cancer", + "tissue": "Lung", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 559, + "type": "STRUCTURAL_VARIANT", + "name": "Fusions", + "alteration": "Fusions", + "proteinChange": "", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 21832, + "entrezGeneId": 238, + "hugoSymbol": "ALK", + "hgncId": "427", + "evidences": null + } + ], + "consequence": { + "id": 39, + "term": "UNKNOWN", + "name": "Unknown", + "isGenerallyTruncating": false, + "description": "Unknown status", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 138, + "name": null, + "drugs": [ + { + "id": 61, + "uuid": "e3f55518-0ebb-4998-9e78-3124b5b987ec", + "name": "Brigatinib" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + } + ], + "specimenTypes": [ + { + "id": 3, + "type": "FFPE", + "name": "FFPE" + } + ] + }, + { + "id": 29, + "name": "xT CDx ", + "manufacturer": "Tempus Labs, Inc.", + "indicationDetails": null, + "platformType": "NGS", + "lastUpdated": "2024-01-11T17:01:27.506445Z", + "fdaSubmissions": [ + { + "id": 77, + "number": "P210011", + "supplementNumber": "", + "deviceName": "xT CDx", + "genericName": "Next generation sequencing oncology panel, somatic or germline variant detection system", + "dateReceived": "2021-03-23T00:00:00Z", + "decisionDate": "2023-04-28T00:00:00Z", + "description": "Approval for the xT CDx. The device is a qualitative Next Generation Sequencing (NGS)-based in vitro diagnostic device intended for use in the detection of substitutions (single nucleotide variants (SNVs) and multi-nucleotide variants (MNVs)) and insertion and deletion alterations (INDELs) in 648 genes, as well as microsatellite instability (MSI) status, using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens, and DNA isolated from matched normal blood or saliva specimens, from previously diagnosed cancer patients with solid malignant neoplasms.The test is intended as a companion diagnostic (CDx) to identify patients who may benefit from treatment with the targeted therapies listed in the Companion Diagnostic Indications table in accordance with the approved therapeutic product labeling.Additionally, xT CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with previously diagnosed solid malignant neoplasms. Genomic findings other than those listed in the Companion Diagnostic Indications table are not prescriptive or conclusive for labeled use of any specific therapeutic product.xT CDx is a single-site assay performed at Tempus Labs, Inc., Chicago, IL.", + "curated": true, + "genetic": false, + "note": null, + "associations": [ + { + "id": 121, + "name": null, + "associationCancerTypes": [ + { + "id": 152, + "relation": "INCLUSION", + "cancerType": { + "id": 874, + "code": null, + "color": "SaddleBrown", + "level": 0, + "mainType": "Colorectal Cancer", + "subtype": null, + "tissue": "Bowel", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 10204, + "type": "NA", + "name": "Wildtype", + "alteration": "Wildtype", + "proteinChange": "", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 30480, + "entrezGeneId": 3845, + "hugoSymbol": "KRAS", + "hgncId": "6407", + "evidences": null + } + ], + "consequence": { + "id": 3, + "term": "ANY", + "name": "Any", + "isGenerallyTruncating": false, + "description": "Any variant", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 139, + "name": null, + "drugs": [ + { + "id": 123, + "uuid": "5fce3074-e420-4c36-9603-2423daf20118", + "name": "Cetuximab" + } + ] + }, + { + "id": 140, + "name": null, + "drugs": [ + { + "id": 103, + "uuid": "3bbe37b1-edc8-4c54-93f8-5360d9a83d69", + "name": "Chemotherapy" + }, + { + "id": 123, + "uuid": "5fce3074-e420-4c36-9603-2423daf20118", + "name": "Cetuximab" + } + ] + } + ] + }, + { + "id": 122, + "name": null, + "associationCancerTypes": [ + { + "id": 153, + "relation": "INCLUSION", + "cancerType": { + "id": 874, + "code": null, + "color": "SaddleBrown", + "level": 0, + "mainType": "Colorectal Cancer", + "subtype": null, + "tissue": "Bowel", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 10204, + "type": "NA", + "name": "Wildtype", + "alteration": "Wildtype", + "proteinChange": "", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 30480, + "entrezGeneId": 3845, + "hugoSymbol": "KRAS", + "hgncId": "6407", + "evidences": null + } + ], + "consequence": { + "id": 3, + "term": "ANY", + "name": "Any", + "isGenerallyTruncating": false, + "description": "Any variant", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 141, + "name": null, + "drugs": [ + { + "id": 65, + "uuid": "d7b1d12a-e942-4801-bb64-916c9bdfaaf3", + "name": "Panitumumab" + } + ] + }, + { + "id": 142, + "name": null, + "drugs": [ + { + "id": 65, + "uuid": "d7b1d12a-e942-4801-bb64-916c9bdfaaf3", + "name": "Panitumumab" + }, + { + "id": 103, + "uuid": "3bbe37b1-edc8-4c54-93f8-5360d9a83d69", + "name": "Chemotherapy" + } + ] + } + ] + }, + { + "id": 123, + "name": null, + "associationCancerTypes": [ + { + "id": 154, + "relation": "INCLUSION", + "cancerType": { + "id": 874, + "code": null, + "color": "SaddleBrown", + "level": 0, + "mainType": "Colorectal Cancer", + "subtype": null, + "tissue": "Bowel", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 12816, + "type": "NA", + "name": "Wildtype", + "alteration": "Wildtype", + "proteinChange": "", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 17596, + "entrezGeneId": 4893, + "hugoSymbol": "NRAS", + "hgncId": "7989", + "evidences": null + } + ], + "consequence": { + "id": 3, + "term": "ANY", + "name": "Any", + "isGenerallyTruncating": false, + "description": "Any variant", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 143, + "name": null, + "drugs": [ + { + "id": 65, + "uuid": "d7b1d12a-e942-4801-bb64-916c9bdfaaf3", + "name": "Panitumumab" + } + ] + }, + { + "id": 144, + "name": null, + "drugs": [ + { + "id": 65, + "uuid": "d7b1d12a-e942-4801-bb64-916c9bdfaaf3", + "name": "Panitumumab" + }, + { + "id": 103, + "uuid": "3bbe37b1-edc8-4c54-93f8-5360d9a83d69", + "name": "Chemotherapy" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + } + ], + "specimenTypes": [ + { + "id": 3, + "type": "FFPE", + "name": "FFPE" + }, + { + "id": 8, + "type": "FFPE_MN_BLOOD", + "name": "FFPE with matched normal from blood" + }, + { + "id": 9, + "type": "FFPE_MN_SALIVA", + "name": "FFPE with matched normal from saliva" + } + ] + }, + { + "id": 30, + "name": "PDGFRB FISH Assay ", + "manufacturer": "ARUP Laboratories, Inc.", + "indicationDetails": null, + "platformType": "FISH", + "lastUpdated": "2024-01-11T17:01:27.827271Z", + "fdaSubmissions": [ + { + "id": 78, + "number": "H140005", + "supplementNumber": "", + "deviceName": "PDGFRB FISH ASSAY", + "genericName": "fluorescence in situ hybridization, platelet-derived growth factor receptor, beta polypeptide (pdgfrb), rearrangement", + "dateReceived": "2014-11-26T00:00:00Z", + "decisionDate": "2015-12-18T00:00:00Z", + "description": "Approval for the pdgfrb fish for gleevec eligibility in myelodysplastic syndrome/myeloproliferative disease (mds/mpd). This device is indicated for the qualitative detection of pdgfrb gene rearrangement from fresh bone marrow samples of patients with mds/mpd with a high index of suspicion based on karyotyping showing a 5q31~33 anomaly. The pdgfrb fish assay is indicated as an aid in the selection of mds/mpd patients for whom gleevec (imatinib mesylate) treatment is being considered. This assay is for professional use only and is to be performed at a single laboratory site. ", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 124, + "name": null, + "associationCancerTypes": [ + { + "id": 155, + "relation": "INCLUSION", + "cancerType": { + "id": 380, + "code": "MDS/MPN", + "color": "LightSalmon", + "level": 3, + "mainType": "Myelodysplastic/Myeloproliferative Neoplasms", + "subtype": "Myelodysplastic/Myeloproliferative Neoplasms", + "tissue": "Myeloid", + "tumorForm": "LIQUID" + } + } + ], + "alterations": [ + { + "id": 13310, + "type": "STRUCTURAL_VARIANT", + "name": "Fusions", + "alteration": "Fusions", + "proteinChange": "", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 41957, + "entrezGeneId": 5159, + "hugoSymbol": "PDGFRB", + "hgncId": "8804", + "evidences": null + } + ], + "consequence": { + "id": 39, + "term": "UNKNOWN", + "name": "Unknown", + "isGenerallyTruncating": false, + "description": "Unknown status", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 145, + "name": null, + "drugs": [ + { + "id": 138, + "uuid": "f42768c5-4918-4244-98dd-6ea97a4d3c2a", + "name": "Imatinib" + } + ] + } + ] + } + ], + "type": { + "id": 3, + "type": "HDE", + "name": "Humanitarian Device Exemption", + "shortName": "HDE", + "description": "Searchable listing of Humanitarian Device Exemption (HDE) Class III medical devices." + } + } + ], + "specimenTypes": [ + { + "id": 4, + "type": "BONE_MARROW", + "name": "Bone marrow" + } + ] + }, + { + "id": 31, + "name": "Praxis Extended RAS Panel ", + "manufacturer": "Illumina, Inc.", + "indicationDetails": null, + "platformType": "NGS", + "lastUpdated": "2024-01-11T17:01:28.384713Z", + "fdaSubmissions": [ + { + "id": 79, + "number": "P160038", + "supplementNumber": "", + "deviceName": "Praxis Extended RAS Panel", + "genericName": "Next generation sequencing oncology panel, somatic or germline variant detection system", + "dateReceived": "2016-09-02T00:00:00Z", + "decisionDate": "2017-06-29T00:00:00Z", + "description": "Approval for the Praxis Extended RAS Panel is a qualitative in vitro diagnostic test using targeted high throughput parallel sequencing for the detection of 56 specific mutations in RAS genes [KRAS (exons 2, 3, and 4) and NRAS (exons 2, 3, and 4)] in DNA extracted from formalin-fixed, paraffin-embedded (FFPE) colorectal cancer (CRC) tissue samples. The Praxis™ Extended RAS Panel is indicated to aid in the identification of patients with colorectal cancer for treatment with Vectibix® (panitumumab) based on a no mutation detected test result. The test is intended to be used on the Illumina MiSeqDx® instrument.", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 125, + "name": null, + "associationCancerTypes": [ + { + "id": 156, + "relation": "INCLUSION", + "cancerType": { + "id": 874, + "code": null, + "color": "SaddleBrown", + "level": 0, + "mainType": "Colorectal Cancer", + "subtype": null, + "tissue": "Bowel", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 10204, + "type": "NA", + "name": "Wildtype", + "alteration": "Wildtype", + "proteinChange": "", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 30480, + "entrezGeneId": 3845, + "hugoSymbol": "KRAS", + "hgncId": "6407", + "evidences": null + } + ], + "consequence": { + "id": 3, + "term": "ANY", + "name": "Any", + "isGenerallyTruncating": false, + "description": "Any variant", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 146, + "name": null, + "drugs": [ + { + "id": 65, + "uuid": "d7b1d12a-e942-4801-bb64-916c9bdfaaf3", + "name": "Panitumumab" + } + ] + }, + { + "id": 147, + "name": null, + "drugs": [ + { + "id": 65, + "uuid": "d7b1d12a-e942-4801-bb64-916c9bdfaaf3", + "name": "Panitumumab" + }, + { + "id": 103, + "uuid": "3bbe37b1-edc8-4c54-93f8-5360d9a83d69", + "name": "Chemotherapy" + } + ] + } + ] + }, + { + "id": 126, + "name": null, + "associationCancerTypes": [ + { + "id": 157, + "relation": "INCLUSION", + "cancerType": { + "id": 874, + "code": null, + "color": "SaddleBrown", + "level": 0, + "mainType": "Colorectal Cancer", + "subtype": null, + "tissue": "Bowel", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 12816, + "type": "NA", + "name": "Wildtype", + "alteration": "Wildtype", + "proteinChange": "", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 17596, + "entrezGeneId": 4893, + "hugoSymbol": "NRAS", + "hgncId": "7989", + "evidences": null + } + ], + "consequence": { + "id": 3, + "term": "ANY", + "name": "Any", + "isGenerallyTruncating": false, + "description": "Any variant", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 148, + "name": null, + "drugs": [ + { + "id": 65, + "uuid": "d7b1d12a-e942-4801-bb64-916c9bdfaaf3", + "name": "Panitumumab" + } + ] + }, + { + "id": 149, + "name": null, + "drugs": [ + { + "id": 65, + "uuid": "d7b1d12a-e942-4801-bb64-916c9bdfaaf3", + "name": "Panitumumab" + }, + { + "id": 103, + "uuid": "3bbe37b1-edc8-4c54-93f8-5360d9a83d69", + "name": "Chemotherapy" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + } + ], + "specimenTypes": [ + { + "id": 3, + "type": "FFPE", + "name": "FFPE" + } + ] + }, + { + "id": 32, + "name": "SPOT-LIGHT HER2 CISH Kit ", + "manufacturer": "Life Technologies Corporation", + "indicationDetails": null, + "platformType": "CISH", + "lastUpdated": "2024-01-11T17:01:29.049550Z", + "fdaSubmissions": [ + { + "id": 80, + "number": "P050040", + "supplementNumber": "", + "deviceName": "SPOT-LIGHT HER2 CISH KIT", + "genericName": "Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer", + "dateReceived": "2005-11-03T00:00:00Z", + "decisionDate": "2008-07-01T00:00:00Z", + "description": "APPROVAL FOR SPOT-LIGHT HER2 CISH KIT. THIS DEVICE IS INDICATED FOR: THE SPOT-LIGHT HER2 CISH KIT IS INTENDED TO QUANTITATIVELY DETERMINE HER2 GENE AMPLIFICATION IN FORMALIN-FIXED, PARAFFIN-EMBEDDED (FFPE) BREAST CARCINOMA TISSUE SECTIONS USING CHROMOGENIC IN SITU HYBRIDIZATION (CISH) AND BRIGHTFIELD MICROSCOPY. THIS TEST SHOULD BE PERFORMED IN A HISTOPATHOLOGY LABORATORY. THE SPOT-LIGHT HER2 CISH KIT IS INDICATED AS AN AID IN THE ASSESSMENT OF PATIENTS FOR WHOM HERCEPTIN (TRASTUZUMAB) TREATMENT IS BEING CONSIDERED. THE ASSAY RESULTS ARE INTENDED FOR USE AS AN ADJUNCT TO THE CLINICOPATHOLOGICAL INFORMATION CURRENTLY BEING USED AS PART OF THE MANAGEMENT OF BREAST CANCER PATIENTS. INTERPRETATION OF TEST RESULTS MUST BE MADE WITHIN THE CONTEXT OF THE PATIENT'S CLINICAL HISTORY BY A QUALIFIED PATHOLOGIST.", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 127, + "name": null, + "associationCancerTypes": [ + { + "id": 158, + "relation": "INCLUSION", + "cancerType": { + "id": 978, + "code": null, + "color": "HotPink", + "level": 0, + "mainType": "Breast Cancer", + "subtype": null, + "tissue": "Breast", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 6079, + "type": "COPY_NUMBER_ALTERATION", + "name": "Amplification", + "alteration": "Amplification", + "proteinChange": "", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 7677, + "entrezGeneId": 2064, + "hugoSymbol": "ERBB2", + "hgncId": "3430", + "evidences": null + } + ], + "consequence": { + "id": 39, + "term": "UNKNOWN", + "name": "Unknown", + "isGenerallyTruncating": false, + "description": "Unknown status", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 150, + "name": null, + "drugs": [ + { + "id": 38, + "uuid": "b29b3641-d866-4b09-bff6-3063d8316935", + "name": "Trastuzumab" + } + ] + }, + { + "id": 151, + "name": null, + "drugs": [ + { + "id": 38, + "uuid": "b29b3641-d866-4b09-bff6-3063d8316935", + "name": "Trastuzumab" + }, + { + "id": 103, + "uuid": "3bbe37b1-edc8-4c54-93f8-5360d9a83d69", + "name": "Chemotherapy" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + } + ], + "specimenTypes": [ + { + "id": 3, + "type": "FFPE", + "name": "FFPE" + } + ] + }, + { + "id": 33, + "name": "therascreen BRAF V600E RGQ PCR Kit ", + "manufacturer": "QIAGEN GmbH", + "indicationDetails": null, + "platformType": "PCR", + "lastUpdated": "2024-01-11T17:01:29.493351Z", + "fdaSubmissions": [ + { + "id": 81, + "number": "P190026", + "supplementNumber": "", + "deviceName": "therascreen BRAF V600E RGQ PCR Kit", + "genericName": "Somatic gene mutation detection system", + "dateReceived": "2019-09-30T00:00:00Z", + "decisionDate": "2020-04-15T00:00:00Z", + "description": "Approval for the therascreen BRAF V600E RGQ PCR Kit. The therascreen BRAF V600E RGQ PCR Kit is a real-time PCR test for the qualitative detection of V600E mutations in the BRAF gene using genomic DNA extracted from formalin-fixed paraffin-embedded (FFPE) human colorectal cancer (CRC) tumor tissue. The therascreen BRAF V600E RGQ PCR Kit is an in vitro diagnostic device intended to be used as an aid in selecting patients with metastatic colorectal cancer (mCRC) whose tumors carry the BRAF V600E mutation for treatment with BRAFTOVI (encorafenib) in combination with cetuximab. The therascreen BRAF V600E RGQ PCR Kit is for use on the Rotor-Gene Q MDx (US) instrument. The therascreen BRAF V600E RGQ PCR Kit is intended for in vitro diagnostic use. ", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 128, + "name": null, + "associationCancerTypes": [ + { + "id": 159, + "relation": "INCLUSION", + "cancerType": { + "id": 874, + "code": null, + "color": "SaddleBrown", + "level": 0, + "mainType": "Colorectal Cancer", + "subtype": null, + "tissue": "Bowel", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 1388, + "type": "PROTEIN_CHANGE", + "name": "V600E", + "alteration": "V600E", + "proteinChange": "V600E", + "start": 600, + "end": 600, + "refResidues": "V", + "variantResidues": "E", + "genes": [ + { + "id": 41259, + "entrezGeneId": 673, + "hugoSymbol": "BRAF", + "hgncId": "1097", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 152, + "name": null, + "drugs": [ + { + "id": 117, + "uuid": "001e534f-3e63-432f-90a6-d1af1759e4e2", + "name": "Encorafenib" + }, + { + "id": 123, + "uuid": "5fce3074-e420-4c36-9603-2423daf20118", + "name": "Cetuximab" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + } + ], + "specimenTypes": [ + { + "id": 3, + "type": "FFPE", + "name": "FFPE" + } + ] + }, + { + "id": 34, + "name": "therascreen EGFR RGQ PCR Kit ", + "manufacturer": "Qiagen Manchester, Ltd.", + "indicationDetails": null, + "platformType": "PCR", + "lastUpdated": "2024-01-11T17:01:32.262924Z", + "fdaSubmissions": [ + { + "id": 82, + "number": "P120022", + "supplementNumber": "", + "deviceName": "THERASCREEN EGFR RGQ PCR KIT", + "genericName": "Somatic gene mutation detection system", + "dateReceived": "2012-11-30T00:00:00Z", + "decisionDate": "2013-07-12T00:00:00Z", + "description": "APPROVAL FOR THE THERASCREEN® EGFR RGQ PCR KIT. THIS DEVICE IS INDICATED FOR: THE THERASCREEN® EGFR RGQ PCR KIT IS A REAL-TIME PCR TEST FOR THE QUALITATIVE DETECTION OF EXON 19 DELETIONS AND EXON 21 (L858R) SUBSTITUTION MUTATIONS OF THE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) GENE IN DNA DERIVED FROM FORMALIN-FIXED PARAFFIN-EMBEDDED (FFPE) NONSMALL CELL LUNG CANCER (NSCLC) TUMOR TISSUE. THE TEST IS INTENDED TO BE USED TO SELECT PATIENTS WITH NSCLC FOR WHOM GILOTRJF (AFATINIB), AN EGFR TYROSINE KINASE INHIBITOR (TKI), IS INDICATED. SAFETY AND EFFICACY OF GILOTRIF (AFATINIB) HAVE NOT BEEN ESTABLISHED IN PATIENTS WHOSE TUMORS HAVE L861Q, G719X, 87681, EXON 20 INSERTIONS, AND T790M MUTATIONS, WHICH ARE ALSO DETECTED BY THE THERASCREEN® EGFR RGQ PCR KIT. SPECIMENS ARE PROCESSED USING THE QIAAMP® DSP DNA FFPE TISSUE KIT FOR MANUAL SAMPLE PREPARATION AND THE ROTOR-GENE® Q MDX INSTRUMENT FOR AUTOMATED AMPLIFICATION ANDDETECTION.", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 129, + "name": null, + "associationCancerTypes": [ + { + "id": 160, + "relation": "INCLUSION", + "cancerType": { + "id": 64, + "code": "NSCLC", + "color": "Gainsboro", + "level": 2, + "mainType": "Non-Small Cell Lung Cancer", + "subtype": "Non-Small Cell Lung Cancer", + "tissue": "Lung", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 5023, + "type": "PROTEIN_CHANGE", + "name": "L858R", + "alteration": "L858R", + "proteinChange": "L858R", + "start": 858, + "end": 858, + "refResidues": "L", + "variantResidues": "R", + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 5027, + "type": "PROTEIN_CHANGE", + "name": "Exon 19 in-frame deletions", + "alteration": "729_761del", + "proteinChange": "729_761del", + "start": 729, + "end": 761, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 11, + "term": "INFRAME_DELETION", + "name": "Inframe Deletion", + "isGenerallyTruncating": false, + "description": "An inframe non synonymous variant that deletes bases from the coding sequence", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 153, + "name": null, + "drugs": [ + { + "id": 58, + "uuid": "e1f45ae7-33ae-428c-9e77-da4a9b7270b6", + "name": "Afatinib" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + }, + { + "id": 83, + "number": "P120022", + "supplementNumber": "S001", + "deviceName": "THERASCEEN EGFR RGQ PCR KIT", + "genericName": "Somatic gene mutation detection system", + "dateReceived": "2014-09-18T00:00:00Z", + "decisionDate": "2015-07-10T00:00:00Z", + "description": "APPROVAL FOR EXTENDING THE LABEL CLAIM OF THE THERASCREEN® EGFR RGQ PCR KIT TO INCLUDE AN INDICATION FOR IRESSA (GEFITINIB). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THERASCREEN® EGFR RGQ PCR KIT AND IS INDICATED FOR:THE THERASCREEN® EGFR RGQ PCR KIT IS A REAL-TIME PCR TEST FOR THE QUALITATIVE DETECTION OF EXON 19 DELETIONS AND EXON 21 (L858R) SUBSTITUTION MUTATIONS OF THE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) GENE IN DNA DERIVED FROM FORMALIN-FIXED PARAFFIN-EMBEDDED (FFPE) NON-SMALL CELL LUNG CANCER (NSCLC) TUMOR TISSUE. THE TEST IS INTENDED TO BE USED TO SELECT PATIENTS WITH NSCLC FOR WHOM GILOTRIF (AFATINIB) OR IRESSA (GEFITINIB), EGFR TYROSINE KINASE INHIBITORS (TKIS), IS INDICATED. SAFETY AND EFFICACY OF GILOTRIF (AFATINIB) AND IRESSA (GEFITINIB) HAVE NOT BEEN ESTABLISHED IN THE PATIENTS WHOSE TUMORS HAVE L861Q, G719X, S768I, EXON 20 INSERTIONS, AND T790M MUTATIONS, WHICH ARE ALSO DETECTED BY THE THERASCREEN EGFR RGQ PCR KIT.SPECIMENS ARE PROCESSED USING THE QIAAMP DSP DNA FFPE TISSUE KIT FOR MANUAL SAMPLE PREPARATION AND THE ROTOR-GENE Q MDX INSTRUMENT FOR AUTOMATED AMPLIFICATION AND DETECTION.", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 130, + "name": null, + "associationCancerTypes": [ + { + "id": 161, + "relation": "INCLUSION", + "cancerType": { + "id": 64, + "code": "NSCLC", + "color": "Gainsboro", + "level": 2, + "mainType": "Non-Small Cell Lung Cancer", + "subtype": "Non-Small Cell Lung Cancer", + "tissue": "Lung", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 5023, + "type": "PROTEIN_CHANGE", + "name": "L858R", + "alteration": "L858R", + "proteinChange": "L858R", + "start": 858, + "end": 858, + "refResidues": "L", + "variantResidues": "R", + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 5027, + "type": "PROTEIN_CHANGE", + "name": "Exon 19 in-frame deletions", + "alteration": "729_761del", + "proteinChange": "729_761del", + "start": 729, + "end": 761, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 11, + "term": "INFRAME_DELETION", + "name": "Inframe Deletion", + "isGenerallyTruncating": false, + "description": "An inframe non synonymous variant that deletes bases from the coding sequence", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 154, + "name": null, + "drugs": [ + { + "id": 33, + "uuid": "b76d7b2b-b5fb-4561-892f-6b00bfaf0dfa", + "name": "Gefitinib" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + }, + { + "id": 84, + "number": "P120022", + "supplementNumber": "S016", + "deviceName": "Therascreen EGFR RGQ PCR Kit", + "genericName": "Somatic gene mutation detection system", + "dateReceived": "2017-07-28T00:00:00Z", + "decisionDate": "2016-01-12T00:00:00Z", + "description": "Approval for extending the labeling claim of the therascreen® EGFR RGQ PCR Kit to include detection of EGFR mutations L861Q, G719X and S768I, to aid in identifying patients with NSCLC for whom safety and efficacy of GILOTRIF® (afatininb) has been established.", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 131, + "name": null, + "associationCancerTypes": [ + { + "id": 162, + "relation": "INCLUSION", + "cancerType": { + "id": 64, + "code": "NSCLC", + "color": "Gainsboro", + "level": 2, + "mainType": "Non-Small Cell Lung Cancer", + "subtype": "Non-Small Cell Lung Cancer", + "tissue": "Lung", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 5041, + "type": "PROTEIN_CHANGE", + "name": "L861Q", + "alteration": "L861Q", + "proteinChange": "L861Q", + "start": 861, + "end": 861, + "refResidues": "L", + "variantResidues": "Q", + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 155, + "name": null, + "drugs": [ + { + "id": 58, + "uuid": "e1f45ae7-33ae-428c-9e77-da4a9b7270b6", + "name": "Afatinib" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + }, + { + "id": 85, + "number": "P120022", + "supplementNumber": "S018", + "deviceName": "therascreen EGFR RGQ PCR Kit", + "genericName": "Somatic gene mutation detection system", + "dateReceived": "2018-02-16T00:00:00Z", + "decisionDate": "2018-09-27T00:00:00Z", + "description": "Approval for to extend the intended use of the therascreen® EGFR RGQ PCR Kit to include the selection of patients with NSCLC for whom dacomitinib is indicated.", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 132, + "name": null, + "associationCancerTypes": [ + { + "id": 163, + "relation": "INCLUSION", + "cancerType": { + "id": 64, + "code": "NSCLC", + "color": "Gainsboro", + "level": 2, + "mainType": "Non-Small Cell Lung Cancer", + "subtype": "Non-Small Cell Lung Cancer", + "tissue": "Lung", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 5023, + "type": "PROTEIN_CHANGE", + "name": "L858R", + "alteration": "L858R", + "proteinChange": "L858R", + "start": 858, + "end": 858, + "refResidues": "L", + "variantResidues": "R", + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 5027, + "type": "PROTEIN_CHANGE", + "name": "Exon 19 in-frame deletions", + "alteration": "729_761del", + "proteinChange": "729_761del", + "start": 729, + "end": 761, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 24498, + "entrezGeneId": 1956, + "hugoSymbol": "EGFR", + "hgncId": "3236", + "evidences": null + } + ], + "consequence": { + "id": 11, + "term": "INFRAME_DELETION", + "name": "Inframe Deletion", + "isGenerallyTruncating": false, + "description": "An inframe non synonymous variant that deletes bases from the coding sequence", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 156, + "name": null, + "drugs": [ + { + "id": 87, + "uuid": "ee16e91a-38a2-4433-97d2-9b9ae9d2a497", + "name": "Dacomitinib" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + } + ], + "specimenTypes": [ + { + "id": 3, + "type": "FFPE", + "name": "FFPE" + } + ] + }, + { + "id": 35, + "name": "therascreen FGFR RGQ RT-PCR Kit ", + "manufacturer": "QIAGEN Manchester Ltd.", + "indicationDetails": null, + "platformType": "PCR", + "lastUpdated": "2024-01-11T17:01:32.693221Z", + "fdaSubmissions": [ + { + "id": 86, + "number": "P180043", + "supplementNumber": "", + "deviceName": "therascreen FGFR RGQ RT-PCR Kit", + "genericName": "Somatic gene mutation detection system", + "dateReceived": "2018-11-08T00:00:00Z", + "decisionDate": "2019-04-12T00:00:00Z", + "description": "Approval for the THERASCREEN® FGFR RGQ PCR KIT. The Therascreen FGFR RGQ RT-PCR Kit is a real-time, reverse transcription PCR test for the qualitative detection of two point mutations in exon 7 [p.R248C (c.742C>T), p.S249C (c.746C>G)], two point mutations in exon 10 [p.G370C (c.1108G>T) and p.Y373C (c.1118A>G)] and two fusions (FGFR3-TACC3v1 and FGFR3-TACC3v3) in the fibroblast growth factor receptor 3 (FGFR3) gene in RNA samples derived from formalin-fixed paraffin-embedded (FFPE) urothelial tumor tissue. The test is indicated for use as an aid in identifying urothelial cancer (UC) patients who harbor these alterations and are therefore eligible for treatment with BALVERSA (erdafitinib). Specimens are processed using the RNeasy DSP FFPE Kit for manual sample preparation followed by reverse transcription and then automated amplification and detection on the Rotor-Gene Q MDx (US) instrument.", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 133, + "name": null, + "associationCancerTypes": [ + { + "id": 164, + "relation": "INCLUSION", + "cancerType": { + "id": 977, + "code": null, + "color": "Yellow", + "level": 0, + "mainType": "Bladder Cancer", + "subtype": null, + "tissue": "Bladder/Urinary Tract", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 8245, + "type": "PROTEIN_CHANGE", + "name": "R248C", + "alteration": "R248C", + "proteinChange": "R248C", + "start": 248, + "end": 248, + "refResidues": "R", + "variantResidues": "C", + "genes": [ + { + "id": 20766, + "entrezGeneId": 2261, + "hugoSymbol": "FGFR3", + "hgncId": "3690", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 8246, + "type": "PROTEIN_CHANGE", + "name": "S249C", + "alteration": "S249C", + "proteinChange": "S249C", + "start": 249, + "end": 249, + "refResidues": "S", + "variantResidues": "C", + "genes": [ + { + "id": 20766, + "entrezGeneId": 2261, + "hugoSymbol": "FGFR3", + "hgncId": "3690", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 8247, + "type": "PROTEIN_CHANGE", + "name": "Y373C", + "alteration": "Y373C", + "proteinChange": "Y373C", + "start": 373, + "end": 373, + "refResidues": "Y", + "variantResidues": "C", + "genes": [ + { + "id": 20766, + "entrezGeneId": 2261, + "hugoSymbol": "FGFR3", + "hgncId": "3690", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 8282, + "type": "PROTEIN_CHANGE", + "name": "G370C", + "alteration": "G370C", + "proteinChange": "G370C", + "start": 370, + "end": 370, + "refResidues": "G", + "variantResidues": "C", + "genes": [ + { + "id": 20766, + "entrezGeneId": 2261, + "hugoSymbol": "FGFR3", + "hgncId": "3690", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 8287, + "type": "STRUCTURAL_VARIANT", + "name": "Fusions", + "alteration": "Fusions", + "proteinChange": "", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 20766, + "entrezGeneId": 2261, + "hugoSymbol": "FGFR3", + "hgncId": "3690", + "evidences": null + } + ], + "consequence": { + "id": 39, + "term": "UNKNOWN", + "name": "Unknown", + "isGenerallyTruncating": false, + "description": "Unknown status", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 157, + "name": null, + "drugs": [ + { + "id": 93, + "uuid": "f2e41d69-c383-4e33-ba25-0bf5f837db11", + "name": "Erdafitinib" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + } + ], + "specimenTypes": [ + { + "id": 3, + "type": "FFPE", + "name": "FFPE" + } + ] + }, + { + "id": 36, + "name": "therascreen KRAS RGQ PCR Kit ", + "manufacturer": "Qiagen Manchester, Ltd.", + "indicationDetails": null, + "platformType": "PCR", + "lastUpdated": "2024-01-11T17:01:34.466152Z", + "fdaSubmissions": [ + { + "id": 87, + "number": "P110027", + "supplementNumber": "", + "deviceName": "THERASCREEN KRAS RGQ PCR KIT", + "genericName": "Somatic gene mutation detection system", + "dateReceived": "2011-07-25T00:00:00Z", + "decisionDate": "2014-05-23T00:00:00Z", + "description": "APPROVAL FOR THE THERASCREEN KRAS RGQ PCR KIT, WHICH IS TO BE USED AS A COMPANION DIAGNOSTIC FOR THE DRUG VECTIBIX (PANITUMUMAB). THIS DEVICE IS INDICATED FOR:THE THERASCREEN KRAS RGQ PCR KIT IS A REAL-TIME QUALITATIVE PCR ASSAY USED ON THE ROTOR-GENE Q MDX INSTRUMENT FOR THE DETECTION OF SEVEN SOMATIC MUTATIONS IN THE HUMAN KRAS ONCOGENE, USING DNA EXTRACTED FROM FORMALIN-FIXED PARAFFIN-EMBEDDED (FFPE), COLORECTAL CANCER (CRC) TISSUE. THE THERASCREEN KRAS RGQ PCR KIT IS INTENDED TO AID IN THE IDENTIFICATION OF CRC PATIENTS FOR TREATMENT WITH ERBITUX (CETUXIMAB) AND VECTIBIX (PANITUMUMAB) BASED ON A KRAS NO MUTATION DETECTED TEST RESULT.", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 134, + "name": null, + "associationCancerTypes": [ + { + "id": 165, + "relation": "INCLUSION", + "cancerType": { + "id": 874, + "code": null, + "color": "SaddleBrown", + "level": 0, + "mainType": "Colorectal Cancer", + "subtype": null, + "tissue": "Bowel", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 10204, + "type": "NA", + "name": "Wildtype", + "alteration": "Wildtype", + "proteinChange": "", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 30480, + "entrezGeneId": 3845, + "hugoSymbol": "KRAS", + "hgncId": "6407", + "evidences": null + } + ], + "consequence": { + "id": 3, + "term": "ANY", + "name": "Any", + "isGenerallyTruncating": false, + "description": "Any variant", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 158, + "name": null, + "drugs": [ + { + "id": 65, + "uuid": "d7b1d12a-e942-4801-bb64-916c9bdfaaf3", + "name": "Panitumumab" + } + ] + }, + { + "id": 159, + "name": null, + "drugs": [ + { + "id": 65, + "uuid": "d7b1d12a-e942-4801-bb64-916c9bdfaaf3", + "name": "Panitumumab" + }, + { + "id": 103, + "uuid": "3bbe37b1-edc8-4c54-93f8-5360d9a83d69", + "name": "Chemotherapy" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + }, + { + "id": 88, + "number": "P110027", + "supplementNumber": "S012", + "deviceName": "therascreen KRAS RGQ PCR KIT", + "genericName": "Somatic gene mutation detection system", + "dateReceived": "2021-02-10T00:00:00Z", + "decisionDate": "2021-05-28T00:00:00Z", + "description": "Approval for expanding the indication to aid in the identification of non-small cell lung cancer patients whose tumors harbor KRAS G12C mutations and may benefit from treatment with LUMAKRA (sotorasib). ", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 135, + "name": null, + "associationCancerTypes": [ + { + "id": 166, + "relation": "INCLUSION", + "cancerType": { + "id": 64, + "code": "NSCLC", + "color": "Gainsboro", + "level": 2, + "mainType": "Non-Small Cell Lung Cancer", + "subtype": "Non-Small Cell Lung Cancer", + "tissue": "Lung", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 10208, + "type": "PROTEIN_CHANGE", + "name": "G12C", + "alteration": "G12C", + "proteinChange": "G12C", + "start": 12, + "end": 12, + "refResidues": "G", + "variantResidues": "C", + "genes": [ + { + "id": 30480, + "entrezGeneId": 3845, + "hugoSymbol": "KRAS", + "hgncId": "6407", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 160, + "name": null, + "drugs": [ + { + "id": 17, + "uuid": "7d507726-ed2e-4f65-a35a-0e1e88984278", + "name": "Sotorasib" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + }, + { + "id": 89, + "number": "P110030", + "supplementNumber": "", + "deviceName": "THERASCREEN KRAS RGQ PCR KIT", + "genericName": "Somatic gene mutation detection system", + "dateReceived": "2011-07-28T00:00:00Z", + "decisionDate": "2012-07-06T00:00:00Z", + "description": "APPROVAL FOR THE THERASCREEN KRAS RGQ PCR KIT. THIS DEVICE IS INDICATED FOR: THE THERASCREEN KRAS RGQ PCR KIT IS A REAL-TIME QUALITATIVE PCR ASSAY USED ON THE ROTORGENE Q MDX INSTRUMENT FOR THE DETECTION OF SEVEN SOMATIC MUTATIONS IN THE HUMAN KRAS ONCOGENE, USING DNA EXTRACTED FROM FORMALIN FIXED PARAFFIN-EMBEDDED (FFPE), COLORECTAL CANCER (CRC) TISSUE. THE THERASCREEN KRAS RGQ PCR KIT IS INTENDED TO AID IN THE IDENTIFICATION OF CRC PATIENTS FOR TREATMENT WITH ERBITUX (CETUXIMAB) BASED ON A KRAS NO MUTATION DETECTED TEST RESULT.", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 136, + "name": null, + "associationCancerTypes": [ + { + "id": 167, + "relation": "INCLUSION", + "cancerType": { + "id": 874, + "code": null, + "color": "SaddleBrown", + "level": 0, + "mainType": "Colorectal Cancer", + "subtype": null, + "tissue": "Bowel", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 10204, + "type": "NA", + "name": "Wildtype", + "alteration": "Wildtype", + "proteinChange": "", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 30480, + "entrezGeneId": 3845, + "hugoSymbol": "KRAS", + "hgncId": "6407", + "evidences": null + } + ], + "consequence": { + "id": 3, + "term": "ANY", + "name": "Any", + "isGenerallyTruncating": false, + "description": "Any variant", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 161, + "name": null, + "drugs": [ + { + "id": 123, + "uuid": "5fce3074-e420-4c36-9603-2423daf20118", + "name": "Cetuximab" + } + ] + }, + { + "id": 162, + "name": null, + "drugs": [ + { + "id": 103, + "uuid": "3bbe37b1-edc8-4c54-93f8-5360d9a83d69", + "name": "Chemotherapy" + }, + { + "id": 123, + "uuid": "5fce3074-e420-4c36-9603-2423daf20118", + "name": "Cetuximab" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + }, + { + "id": 90, + "number": "P110027", + "supplementNumber": "S013", + "deviceName": "therascreen KRAS RGQ PCR Kit", + "genericName": "Somatic gene mutation detection system", + "dateReceived": "2022-01-19T00:00:00Z", + "decisionDate": "2022-12-02T00:00:00Z", + "description": "Approval for expanding the indication to aid in the identification of non-small cell lung cancer patients whose tumors harbor KRAS G12C mutations and may benefit from treatment with KRAZATI (adagrasib).", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 137, + "name": null, + "associationCancerTypes": [ + { + "id": 168, + "relation": "INCLUSION", + "cancerType": { + "id": 874, + "code": null, + "color": "SaddleBrown", + "level": 0, + "mainType": "Colorectal Cancer", + "subtype": null, + "tissue": "Bowel", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 10204, + "type": "NA", + "name": "Wildtype", + "alteration": "Wildtype", + "proteinChange": "", + "start": null, + "end": null, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 30480, + "entrezGeneId": 3845, + "hugoSymbol": "KRAS", + "hgncId": "6407", + "evidences": null + } + ], + "consequence": { + "id": 3, + "term": "ANY", + "name": "Any", + "isGenerallyTruncating": false, + "description": "Any variant", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 163, + "name": null, + "drugs": [ + { + "id": 123, + "uuid": "5fce3074-e420-4c36-9603-2423daf20118", + "name": "Cetuximab" + } + ] + }, + { + "id": 164, + "name": null, + "drugs": [ + { + "id": 103, + "uuid": "3bbe37b1-edc8-4c54-93f8-5360d9a83d69", + "name": "Chemotherapy" + }, + { + "id": 123, + "uuid": "5fce3074-e420-4c36-9603-2423daf20118", + "name": "Cetuximab" + } + ] + } + ] + }, + { + "id": 138, + "name": null, + "associationCancerTypes": [ + { + "id": 169, + "relation": "INCLUSION", + "cancerType": { + "id": 64, + "code": "NSCLC", + "color": "Gainsboro", + "level": 2, + "mainType": "Non-Small Cell Lung Cancer", + "subtype": "Non-Small Cell Lung Cancer", + "tissue": "Lung", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 10208, + "type": "PROTEIN_CHANGE", + "name": "G12C", + "alteration": "G12C", + "proteinChange": "G12C", + "start": 12, + "end": 12, + "refResidues": "G", + "variantResidues": "C", + "genes": [ + { + "id": 30480, + "entrezGeneId": 3845, + "hugoSymbol": "KRAS", + "hgncId": "6407", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 165, + "name": null, + "drugs": [ + { + "id": 120, + "uuid": "0a7b3eb1-d1f0-4511-aaac-9a696955bf57", + "name": "Adagrasib" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + } + ], + "specimenTypes": [ + { + "id": 3, + "type": "FFPE", + "name": "FFPE" + } + ] + }, + { + "id": 37, + "name": "therascreen PDGFRA RGQ PCR Kit ", + "manufacturer": "QIAGEN GmbH", + "indicationDetails": null, + "platformType": "PCR", + "lastUpdated": "2024-01-11T17:01:35.144681Z", + "fdaSubmissions": [ + { + "id": 91, + "number": "P210002", + "supplementNumber": "", + "deviceName": "therascreen PDGFRA RGQ PCR Kit", + "genericName": "Somatic gene mutation detection system", + "dateReceived": "2021-01-29T00:00:00Z", + "decisionDate": "2023-06-29T00:00:00Z", + "description": "Approval for the therascreen PDGFRA RGQ PCR Kit. The QIAGEN therascreen® PDGFRA RGQ PCR Kit is a real-time qualitative in vitro diagnostic assay for the detection of the D842V somatic mutation in the PDGFRA gene using genomic DNA extracted from Gastrointestinal Stromal Tumor (GIST) patients formalin-fixed paraffin-embedded (FFPE) tumor tissue. The therascreen PDGFRA RGQ PCR Kit is intended for use as a companion diagnostic test, to aid clinicians in identification of patients with GIST who may be eligible for treatment with AYVAKIT (avapritinib) based on a PDGFRA mutation detected result. FFPE tumor specimens are processed using the QIAamp® DSP DNA FFPE Tissue Kit for manual sample preparation and the Rotor-Gene® Q (RGQ) MDx instrument for automated amplification and detection. The therascreen PDGFRA RGQ PCR Kit is to be used by trained personnel in a professional laboratory environment.", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 139, + "name": null, + "associationCancerTypes": [ + { + "id": 170, + "relation": "INCLUSION", + "cancerType": { + "id": 219, + "code": "GIST", + "color": "LightYellow", + "level": 2, + "mainType": "Gastrointestinal Stromal Tumor", + "subtype": "Gastrointestinal Stromal Tumor", + "tissue": "Soft Tissue", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 13273, + "type": "PROTEIN_CHANGE", + "name": "Exon 18 missense mutations", + "alteration": "814_852mis", + "proteinChange": "814_852mis", + "start": 814, + "end": 852, + "refResidues": null, + "variantResidues": null, + "genes": [ + { + "id": 41967, + "entrezGeneId": 5156, + "hugoSymbol": "PDGFRA", + "hgncId": "8803", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 166, + "name": null, + "drugs": [ + { + "id": 73, + "uuid": "3d49e386-0cc4-401e-9acd-d2d33b2923a3", + "name": "Avapritinib" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + } + ], + "specimenTypes": [ + { + "id": 3, + "type": "FFPE", + "name": "FFPE" + } + ] + }, + { + "id": 38, + "name": "therascreen PIK3CA RGQ PCR Kit ", + "manufacturer": "QIAGEN GmbH", + "indicationDetails": null, + "platformType": "PCR", + "lastUpdated": "2024-01-11T17:01:35.815793Z", + "fdaSubmissions": [ + { + "id": 92, + "number": "P190001", + "supplementNumber": "", + "deviceName": "therascreen PIK3CA RGQ PCR Kit", + "genericName": "Somatic gene mutation detection system", + "dateReceived": "2019-01-17T00:00:00Z", + "decisionDate": "2019-05-24T00:00:00Z", + "description": "Approval for the therascreen PIK3CA RGQ PCR Kit. The therascreen PIK3CA RGQ PCR Kit is a real-time qualitative PCR test for the detection of 11 mutations in the phosphatidylinositol 3-kinase catalytic subunit alpha (PIK3CA) gene (Exon 7: C420R; Exon 9: E542K, E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R; and Exon 20: H1047L, H1047R, H1047Y) using genomic DNA (gDNA) extracted from formalin-fixed, paraffin-embedded (FFPE) breast tumor tissue or circulating tumor DNA (ctDNA) from plasma derived from K2EDTA anticoagulated peripheral whole blood taken from patients with breast cancer. The test is intended to aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY® (alpelisib) based on a PIK3CA Mutation Detected result. Patients whose FFPE tissue or plasma specimen produces a positive therascreen PIK3CA RGQ PCR Kit test result for the presence of one or more PIK3CA mutations are eligible for treatment with PIQRAY (alpelisib). Patients whose plasma specimen produces a negative result using this test should be reflexed to testing with FFPE tumor tissue for the presence of PIK3CA mutations. FFPE tumor specimens are processed using the QIAamp DSP DNA FFPE Tissue Kit for manual sample preparation. K2EDTA anticoagulated whole peripheral venous blood plasma specimens are processed using the QIAamp DSP Circulating Nucleic Acid Kit for manual sample preparation. For both specimen types, the Rotor-Gene Q (RGQ) MDx (US) instrument is used for automated amplification and detection. The Kit is to be used by trained personnel in a professional laboratory environment.", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 140, + "name": null, + "associationCancerTypes": [ + { + "id": 171, + "relation": "INCLUSION", + "cancerType": { + "id": 978, + "code": null, + "color": "HotPink", + "level": 0, + "mainType": "Breast Cancer", + "subtype": null, + "tissue": "Breast", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 13431, + "type": "PROTEIN_CHANGE", + "name": "E545K", + "alteration": "E545K", + "proteinChange": "E545K", + "start": 545, + "end": 545, + "refResidues": "E", + "variantResidues": "K", + "genes": [ + { + "id": 39934, + "entrezGeneId": 5290, + "hugoSymbol": "PIK3CA", + "hgncId": "8975", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 13426, + "type": "PROTEIN_CHANGE", + "name": "C420R", + "alteration": "C420R", + "proteinChange": "C420R", + "start": 420, + "end": 420, + "refResidues": "C", + "variantResidues": "R", + "genes": [ + { + "id": 39934, + "entrezGeneId": 5290, + "hugoSymbol": "PIK3CA", + "hgncId": "8975", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 13427, + "type": "PROTEIN_CHANGE", + "name": "E542K", + "alteration": "E542K", + "proteinChange": "E542K", + "start": 542, + "end": 542, + "refResidues": "E", + "variantResidues": "K", + "genes": [ + { + "id": 39934, + "entrezGeneId": 5290, + "hugoSymbol": "PIK3CA", + "hgncId": "8975", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 13428, + "type": "PROTEIN_CHANGE", + "name": "E545A", + "alteration": "E545A", + "proteinChange": "E545A", + "start": 545, + "end": 545, + "refResidues": "E", + "variantResidues": "A", + "genes": [ + { + "id": 39934, + "entrezGeneId": 5290, + "hugoSymbol": "PIK3CA", + "hgncId": "8975", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 13429, + "type": "PROTEIN_CHANGE", + "name": "E545D", + "alteration": "E545D", + "proteinChange": "E545D", + "start": 545, + "end": 545, + "refResidues": "E", + "variantResidues": "D", + "genes": [ + { + "id": 39934, + "entrezGeneId": 5290, + "hugoSymbol": "PIK3CA", + "hgncId": "8975", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 13430, + "type": "PROTEIN_CHANGE", + "name": "E545G", + "alteration": "E545G", + "proteinChange": "E545G", + "start": 545, + "end": 545, + "refResidues": "E", + "variantResidues": "G", + "genes": [ + { + "id": 39934, + "entrezGeneId": 5290, + "hugoSymbol": "PIK3CA", + "hgncId": "8975", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 13432, + "type": "PROTEIN_CHANGE", + "name": "Q546E", + "alteration": "Q546E", + "proteinChange": "Q546E", + "start": 546, + "end": 546, + "refResidues": "Q", + "variantResidues": "E", + "genes": [ + { + "id": 39934, + "entrezGeneId": 5290, + "hugoSymbol": "PIK3CA", + "hgncId": "8975", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 13433, + "type": "PROTEIN_CHANGE", + "name": "Q546R", + "alteration": "Q546R", + "proteinChange": "Q546R", + "start": 546, + "end": 546, + "refResidues": "Q", + "variantResidues": "R", + "genes": [ + { + "id": 39934, + "entrezGeneId": 5290, + "hugoSymbol": "PIK3CA", + "hgncId": "8975", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 13434, + "type": "PROTEIN_CHANGE", + "name": "H1047L", + "alteration": "H1047L", + "proteinChange": "H1047L", + "start": 1047, + "end": 1047, + "refResidues": "H", + "variantResidues": "L", + "genes": [ + { + "id": 39934, + "entrezGeneId": 5290, + "hugoSymbol": "PIK3CA", + "hgncId": "8975", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 13435, + "type": "PROTEIN_CHANGE", + "name": "H1047R", + "alteration": "H1047R", + "proteinChange": "H1047R", + "start": 1047, + "end": 1047, + "refResidues": "H", + "variantResidues": "R", + "genes": [ + { + "id": 39934, + "entrezGeneId": 5290, + "hugoSymbol": "PIK3CA", + "hgncId": "8975", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 13436, + "type": "PROTEIN_CHANGE", + "name": "H1047Y", + "alteration": "H1047Y", + "proteinChange": "H1047Y", + "start": 1047, + "end": 1047, + "refResidues": "H", + "variantResidues": "Y", + "genes": [ + { + "id": 39934, + "entrezGeneId": 5290, + "hugoSymbol": "PIK3CA", + "hgncId": "8975", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 167, + "name": null, + "drugs": [ + { + "id": 32, + "uuid": "b25af9e9-2195-4f16-90ea-7c21fcf3882d", + "name": "Fulvestrant" + }, + { + "id": 83, + "uuid": "d76cc0eb-d098-4133-95a5-5f59fad65f80", + "name": "Alpelisib" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + }, + { + "id": 93, + "number": "P190004", + "supplementNumber": "", + "deviceName": "therascreen PIK3CA RGQ PCR Kit", + "genericName": "Somatic gene mutation detection system", + "dateReceived": "2019-02-15T00:00:00Z", + "decisionDate": "2019-05-24T00:00:00Z", + "description": "Approval for the therascreen PIK3CA RGQ PCR Kit. The therascreen PIK3CA RGQ PCR Kit is a real-time qualitative PCR test for the detection of 11 mutations in the phosphatidylinositol 3-kinase catalytic subunit alpha (PIK3CA) gene (Exon 7: C420R; Exon 9: E542K, E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R; and Exon 20: H1047L, H1047R, H1047Y) using genomic DNA (gDNA) extracted from formalin-fixed, paraffin-embedded (FFPE) breast tumor tissue or circulating tumor DNA (ctDNA) from plasma derived from K2EDTA anticoagulated peripheral whole blood taken from patients with breast cancer. The test is intended to aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY® (alpelisib) based on a PIK3CA Mutation Detected result. Patients whose FFPE tissue or plasma specimen produce a positive therascreen PIK3CA RGQ PCR Kit test result for the presence of one or more PIK3CA mutations are eligible for treatment with PIQRAY (alpelisib). Patients whose plasma specimens produces a negative result using this test should be reflexed to testing with FFPE tumor tissue for the presence of PIK3CA mutations.FFPE tumor specimens are processed using the QIAamp DSP DNA FFPE Tissue Kit for manual sample preparation. K2EDTA anticoagulated whole peripheral venous blood plasma specimens are processed using the QIAamp DSP Circulating Nucleic Acid Kit for manual sample preparation. For both specimen types, the Rotor-Gene Q (RGQ) MDx (US) instrument is used for automated amplification and detection. The Kit is to be used by trained personnel in a professional laboratory environment.", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 140, + "name": null, + "associationCancerTypes": [ + { + "id": 171, + "relation": "INCLUSION", + "cancerType": { + "id": 978, + "code": null, + "color": "HotPink", + "level": 0, + "mainType": "Breast Cancer", + "subtype": null, + "tissue": "Breast", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 13431, + "type": "PROTEIN_CHANGE", + "name": "E545K", + "alteration": "E545K", + "proteinChange": "E545K", + "start": 545, + "end": 545, + "refResidues": "E", + "variantResidues": "K", + "genes": [ + { + "id": 39934, + "entrezGeneId": 5290, + "hugoSymbol": "PIK3CA", + "hgncId": "8975", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 13426, + "type": "PROTEIN_CHANGE", + "name": "C420R", + "alteration": "C420R", + "proteinChange": "C420R", + "start": 420, + "end": 420, + "refResidues": "C", + "variantResidues": "R", + "genes": [ + { + "id": 39934, + "entrezGeneId": 5290, + "hugoSymbol": "PIK3CA", + "hgncId": "8975", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 13427, + "type": "PROTEIN_CHANGE", + "name": "E542K", + "alteration": "E542K", + "proteinChange": "E542K", + "start": 542, + "end": 542, + "refResidues": "E", + "variantResidues": "K", + "genes": [ + { + "id": 39934, + "entrezGeneId": 5290, + "hugoSymbol": "PIK3CA", + "hgncId": "8975", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 13428, + "type": "PROTEIN_CHANGE", + "name": "E545A", + "alteration": "E545A", + "proteinChange": "E545A", + "start": 545, + "end": 545, + "refResidues": "E", + "variantResidues": "A", + "genes": [ + { + "id": 39934, + "entrezGeneId": 5290, + "hugoSymbol": "PIK3CA", + "hgncId": "8975", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 13429, + "type": "PROTEIN_CHANGE", + "name": "E545D", + "alteration": "E545D", + "proteinChange": "E545D", + "start": 545, + "end": 545, + "refResidues": "E", + "variantResidues": "D", + "genes": [ + { + "id": 39934, + "entrezGeneId": 5290, + "hugoSymbol": "PIK3CA", + "hgncId": "8975", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 13430, + "type": "PROTEIN_CHANGE", + "name": "E545G", + "alteration": "E545G", + "proteinChange": "E545G", + "start": 545, + "end": 545, + "refResidues": "E", + "variantResidues": "G", + "genes": [ + { + "id": 39934, + "entrezGeneId": 5290, + "hugoSymbol": "PIK3CA", + "hgncId": "8975", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 13432, + "type": "PROTEIN_CHANGE", + "name": "Q546E", + "alteration": "Q546E", + "proteinChange": "Q546E", + "start": 546, + "end": 546, + "refResidues": "Q", + "variantResidues": "E", + "genes": [ + { + "id": 39934, + "entrezGeneId": 5290, + "hugoSymbol": "PIK3CA", + "hgncId": "8975", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 13433, + "type": "PROTEIN_CHANGE", + "name": "Q546R", + "alteration": "Q546R", + "proteinChange": "Q546R", + "start": 546, + "end": 546, + "refResidues": "Q", + "variantResidues": "R", + "genes": [ + { + "id": 39934, + "entrezGeneId": 5290, + "hugoSymbol": "PIK3CA", + "hgncId": "8975", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 13434, + "type": "PROTEIN_CHANGE", + "name": "H1047L", + "alteration": "H1047L", + "proteinChange": "H1047L", + "start": 1047, + "end": 1047, + "refResidues": "H", + "variantResidues": "L", + "genes": [ + { + "id": 39934, + "entrezGeneId": 5290, + "hugoSymbol": "PIK3CA", + "hgncId": "8975", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 13435, + "type": "PROTEIN_CHANGE", + "name": "H1047R", + "alteration": "H1047R", + "proteinChange": "H1047R", + "start": 1047, + "end": 1047, + "refResidues": "H", + "variantResidues": "R", + "genes": [ + { + "id": 39934, + "entrezGeneId": 5290, + "hugoSymbol": "PIK3CA", + "hgncId": "8975", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 13436, + "type": "PROTEIN_CHANGE", + "name": "H1047Y", + "alteration": "H1047Y", + "proteinChange": "H1047Y", + "start": 1047, + "end": 1047, + "refResidues": "H", + "variantResidues": "Y", + "genes": [ + { + "id": 39934, + "entrezGeneId": 5290, + "hugoSymbol": "PIK3CA", + "hgncId": "8975", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 167, + "name": null, + "drugs": [ + { + "id": 32, + "uuid": "b25af9e9-2195-4f16-90ea-7c21fcf3882d", + "name": "Fulvestrant" + }, + { + "id": 83, + "uuid": "d76cc0eb-d098-4133-95a5-5f59fad65f80", + "name": "Alpelisib" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + } + ], + "specimenTypes": [ + { + "id": 3, + "type": "FFPE", + "name": "FFPE" + } + ] + }, + { + "id": 39, + "name": "THXID BRAF Kit ", + "manufacturer": "bioMérieux Inc.", + "indicationDetails": null, + "platformType": "PCR", + "lastUpdated": "2024-01-11T17:01:36.986892Z", + "fdaSubmissions": [ + { + "id": 94, + "number": "P120014", + "supplementNumber": "", + "deviceName": "BIOMERIEUX THXID BRAF ASSAY KIT", + "genericName": "Somatic gene mutation detection system", + "dateReceived": "2012-07-31T00:00:00Z", + "decisionDate": "2013-05-29T00:00:00Z", + "description": "APPROVAL FOR THE THXID BRAF KIT FOR USE ON THE ABI 7500 FAST DX REAL-TIME PCR INSTRUMENT. THIS DEVICE IS INDICATED FOR: THE THXID BRAF KIT IS AN IN VITRO DIAGNOSTIC DEVICE INTENDED FOR THE QUALITATIVE DETECTION OF THE BRAF V600E AND V600K MUTATIONS IN DNA SAMPLES EXTRACTED FROM FORMALIN-FIXED PARAFFINEMBEDDED (FFPE) HUMAN MELANOMA TISSUE. THE THXID BRAF KIT IS A REAL-TIME PCR TEST ON THE ABI 7500 FAST DX SYSTEM AND IS INTENDED TO BE USED AS AN AID IN SELECTING MELANOMA PATIENTS WHOSE TUMORS CARRY THE BRAF V600E MUTATION FOR TREATMENT WITH DABRAFENIB [TAFINLAR®] AND AS AN AID IN SELECTING MELANOMA PATIENTS WHOSE TUMORS CARRY THE BRAF V600E OR V600K MUTATION FOR TREATMENT WITH TRAMETINIB [MEKINIST].", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 141, + "name": null, + "associationCancerTypes": [ + { + "id": 172, + "relation": "INCLUSION", + "cancerType": { + "id": 172, + "code": "MEL", + "color": "Black", + "level": 2, + "mainType": "Melanoma", + "subtype": "Melanoma", + "tissue": "Skin", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 1388, + "type": "PROTEIN_CHANGE", + "name": "V600E", + "alteration": "V600E", + "proteinChange": "V600E", + "start": 600, + "end": 600, + "refResidues": "V", + "variantResidues": "E", + "genes": [ + { + "id": 41259, + "entrezGeneId": 673, + "hugoSymbol": "BRAF", + "hgncId": "1097", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 1392, + "type": "PROTEIN_CHANGE", + "name": "V600K", + "alteration": "V600K", + "proteinChange": "V600K", + "start": 600, + "end": 600, + "refResidues": "V", + "variantResidues": "K", + "genes": [ + { + "id": 41259, + "entrezGeneId": 673, + "hugoSymbol": "BRAF", + "hgncId": "1097", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 168, + "name": null, + "drugs": [ + { + "id": 122, + "uuid": "fb2bb01c-c0ec-4641-abf7-87f486075022", + "name": "Trametinib" + } + ] + } + ] + }, + { + "id": 142, + "name": null, + "associationCancerTypes": [ + { + "id": 173, + "relation": "INCLUSION", + "cancerType": { + "id": 172, + "code": "MEL", + "color": "Black", + "level": 2, + "mainType": "Melanoma", + "subtype": "Melanoma", + "tissue": "Skin", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 1388, + "type": "PROTEIN_CHANGE", + "name": "V600E", + "alteration": "V600E", + "proteinChange": "V600E", + "start": 600, + "end": 600, + "refResidues": "V", + "variantResidues": "E", + "genes": [ + { + "id": 41259, + "entrezGeneId": 673, + "hugoSymbol": "BRAF", + "hgncId": "1097", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 169, + "name": null, + "drugs": [ + { + "id": 15, + "uuid": "939cd40b-b515-499d-b099-fd29027c0d17", + "name": "Dabrafenib" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + }, + { + "id": 95, + "number": "P120014", + "supplementNumber": "S008", + "deviceName": "THxID BRAF assay kit", + "genericName": "Somatic gene mutation detection system", + "dateReceived": "2017-07-03T00:00:00Z", + "decisionDate": "2018-06-27T00:00:00Z", + "description": "Approval for the THxID®-BRAF kit. It is an In Vitro Diagnostic device intended for the qualitative detection of the BRAF V600E and V600K mutations in DNA samples extracted from formalin-fixed paraffin-embedded (FFPE) human melanoma tissue. The THxID®-BRAF kit is a real-time PCR test on the ABI 7500 Fast Dx system and is intended to be used as an aid in selecting melanoma patients whose tumors carry: the BRAF V600E or V600K mutation for treatment with encorafenib [Braftovi] in combination with binimetinib [Mektovi], the BRAF V600E mutation for treatment with dabrafenib [Tafinlar®], the BRAF V600E or V600K mutation for treatment with trametinib [Mekinist®].", + "curated": true, + "genetic": true, + "note": null, + "associations": [ + { + "id": 143, + "name": null, + "associationCancerTypes": [ + { + "id": 174, + "relation": "INCLUSION", + "cancerType": { + "id": 172, + "code": "MEL", + "color": "Black", + "level": 2, + "mainType": "Melanoma", + "subtype": "Melanoma", + "tissue": "Skin", + "tumorForm": "SOLID" + } + } + ], + "alterations": [ + { + "id": 1388, + "type": "PROTEIN_CHANGE", + "name": "V600E", + "alteration": "V600E", + "proteinChange": "V600E", + "start": 600, + "end": 600, + "refResidues": "V", + "variantResidues": "E", + "genes": [ + { + "id": 41259, + "entrezGeneId": 673, + "hugoSymbol": "BRAF", + "hgncId": "1097", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + }, + { + "id": 1392, + "type": "PROTEIN_CHANGE", + "name": "V600K", + "alteration": "V600K", + "proteinChange": "V600K", + "start": 600, + "end": 600, + "refResidues": "V", + "variantResidues": "K", + "genes": [ + { + "id": 41259, + "entrezGeneId": 673, + "hugoSymbol": "BRAF", + "hgncId": "1097", + "evidences": null + } + ], + "consequence": { + "id": 16, + "term": "MISSENSE_VARIANT", + "name": "Missense Variant", + "isGenerallyTruncating": false, + "description": "A sequence variant, that changes one or more bases, resulting in a different amino acid sequence but where the length is preserved", + "categoricalAlterations": null + } + } + ], + "articles": null, + "treatments": [ + { + "id": 170, + "name": null, + "drugs": [ + { + "id": 117, + "uuid": "001e534f-3e63-432f-90a6-d1af1759e4e2", + "name": "Encorafenib" + }, + { + "id": 119, + "uuid": "feb9f4a3-e374-4c75-8a3b-0f1fbcdbf677", + "name": "Binimetinib" + } + ] + } + ] + } + ], + "type": { + "id": 1, + "type": "PMA", + "name": "Premarket Approval", + "shortName": "PMA", + "description": "Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week." + } + } + ], + "specimenTypes": [ + { + "id": 3, + "type": "FFPE", + "name": "FFPE" + } + ] + } +] diff --git a/src/main/webapp/content/files/oncologyTherapies/fda_approved_oncology_therapies.json b/src/main/webapp/content/files/oncologyTherapies/fda_approved_oncology_therapies.json index be607c64e..4e934248e 100644 --- a/src/main/webapp/content/files/oncologyTherapies/fda_approved_oncology_therapies.json +++ b/src/main/webapp/content/files/oncologyTherapies/fda_approved_oncology_therapies.json @@ -1192,12 +1192,12 @@ { "year": "2017", "tx": "Inotuzumab Ozogamicin", - "biomarker": "", + "biomarker": "CD22", "agentClass": "Hematopoietic protein binding antibody, ADC or cytotoxin", "drugTarget": "CD22-directed antibody-drug conjugate", "targetedTx": "Y", - "pxTx": "N", - "ngsTest": "NA" + "pxTx": "Y", + "ngsTest": "N" }, { "year": "2017", @@ -2168,5 +2168,35 @@ "targetedTx": "Y", "pxTx": "N", "ngsTest": "NA" + }, + { + "year": "2024", + "tx": "Lifileucel", + "biomarker": "", + "agentClass": "Other Immunotherapy", + "drugTarget": "Tumor-infiltrating lymphocyte therapy", + "targetedTx": "Y", + "pxTx": "N", + "ngsTest": "NA" + }, + { + "year": "2024", + "tx": "Nogapendekin alfa inbakicept", + "biomarker": "", + "agentClass": "Other Immunotherapy", + "drugTarget": "Interleukin-15 (IL-15) antagonist", + "targetedTx": "Y", + "pxTx": "N", + "ngsTest": "NA" + }, + { + "year": "2024", + "tx": "Tovorafenib", + "biomarker": "BRAF Fusions, BRAF Rearrangement, BRAF V600", + "agentClass": "Small molecule kinase inhibitor", + "drugTarget": "RAF inhibitor", + "targetedTx": "Y", + "pxTx": "Y", + "ngsTest": "Y" } ] diff --git a/src/main/webapp/content/files/oncologyTherapies/fda_approved_oncology_therapies.xlsx b/src/main/webapp/content/files/oncologyTherapies/fda_approved_oncology_therapies.xlsx index baf06cd93..f8b4d3ba8 100644 Binary files a/src/main/webapp/content/files/oncologyTherapies/fda_approved_oncology_therapies.xlsx and b/src/main/webapp/content/files/oncologyTherapies/fda_approved_oncology_therapies.xlsx differ diff --git a/src/main/webapp/content/images/oncokb_summary.png b/src/main/webapp/content/images/oncokb_summary.png index 468c141b1..a22af64e8 100644 Binary files a/src/main/webapp/content/images/oncokb_summary.png and b/src/main/webapp/content/images/oncokb_summary.png differ diff --git a/src/main/webapp/index.html b/src/main/webapp/index.html index ff4465165..156cf8c9d 100644 --- a/src/main/webapp/index.html +++ b/src/main/webapp/index.html @@ -15,7 +15,7 @@ - + @@ -23,7 +23,7 @@ - +