{"entity":{"id":"brca-somatic","kind":"biomarker","name":"Tumour (somatic or germline) BRCA1/2 mutation and HRR gene alterations","aka":["somatic BRCA","sBRCA","tumor BRCA","tBRCA","BRCAm","BRCA-mutated","HRR gene mutation","HRRm","homologous recombination repair gene alteration","ATM mutation","PALB2 mutation"],"tldr":"Tumour BRCA testing finds BRCA1/2 mutations in the cancer itself, whether inherited or acquired; wider panels add other repair genes such as ATM and PALB2. Ovarian and prostate cancer labels accept the tumour result for PARP inhibitors.","summary":"Sequencing tumour tissue or plasma DNA detects BRCA1/2 mutations regardless of origin (about a third of ovarian tumour BRCA mutations are somatic only) and, on larger panels, alterations in the homologous recombination repair genes. Olaparib is labelled for germline or somatic BRCA-mutated ovarian cancer (first-line and recurrent maintenance), for HRR gene-mutated metastatic castration-resistant prostate cancer after enzalutamide or abiraterone (PROfound; genes listed on the FoundationOne CDx claim), and with abiraterone for BRCA-mutated mCRPC; rucaparib for BRCA-mutated ovarian cancer and mCRPC from plasma; talazoparib with enzalutamide for HRR gene-mutated mCRPC, the label listing ATM, ATR, BRCA1, BRCA2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2 and RAD51C. FoundationOne CDx and Liquid CDx, FoundationFocus CDxBRCA and myChoice CDx carry the tumour claims.","asOf":"2026-09-23","links":[{"label":"Lynparza prescribing information (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=741ff3e3-dc1a-45a6-84e5-2481b27131aa"},{"label":"Rubraca prescribing information (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0295d202-1cfe-7659-e063-6294a90a476e"},{"label":"Talzenna prescribing information (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=13839d4f-6acf-4ffb-a128-79df59319273"}],"tags":["biomarker","brca"],"related":["brca-germline","hrd-positive"],"cancers":["ovarian","high-grade-serous-ovarian-cancer","platinum-sensitive-ovarian-cancer","prostate-mcrpc"],"sections":[],"technologies":[],"targets":[],"drugs":["olaparib","rucaparib","talazoparib","niraparib","foundationone-cdx","mychoice-cdx"],"companies":[],"institutions":[],"pathways":[],"terms":["hrd","germline-vs-somatic","brca-reversion-mutations","ngs"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"target":"brca","measurement":"sequencing-variant","scoringRule":{"text":"A deleterious or suspected deleterious BRCA1 or BRCA2 mutation (germline and/or somatic) in tumour tissue or plasma; for the HRR indications, an alteration in one of the label's listed homologous recombination repair genes. A negative plasma result does not exclude a tumour mutation.","quote":"A negative result from a plasma specimen does not mean that the patient's tumor is negative for BRCA mutations.","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0295d202-1cfe-7659-e063-6294a90a476e","sourceLabel":"Rubraca prescribing information"},"thresholds":[{"value":"Germline or somatic BRCA mutation","drugId":"olaparib","cancerId":"ovarian","regulator":"FDA","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=741ff3e3-dc1a-45a6-84e5-2481b27131aa","quote":"for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA -mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.","status":"current"},{"value":"Germline or somatic HRR gene mutation","drugId":"olaparib","cancerId":"prostate-mcrpc","regulator":"FDA","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=741ff3e3-dc1a-45a6-84e5-2481b27131aa","quote":"Lynparza is indicated for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone.","status":"current"},{"value":"BRCA mutation (germline and/or somatic)","drugId":"rucaparib","cancerId":"ovarian","regulator":"FDA","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0295d202-1cfe-7659-e063-6294a90a476e","quote":"for the maintenance treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.","status":"current"},{"value":"HRR gene alteration (ATM, ATR, BRCA1, BRCA2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, RAD51C)","drugId":"talazoparib","cancerId":"prostate-mcrpc","regulator":"FDA","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=13839d4f-6acf-4ffb-a128-79df59319273","quote":"Select patients for the treatment of HRR gene-mutated mCRPC with TALZENNA based on the presence of alterations in genes directly or indirectly involved in HRR ( ATM , ATR , BRCA1 , BRCA2 , CDK12 , CHEK2 , FANCA , MLH1 , MRE11A , NBN , PALB2 , or RAD51C )","status":"current"}],"tests":["foundationone-cdx","foundationone-liquid-cdx","mychoice-cdx","tempus-xt","caris-mi-cancer-seek","trusight-oncology-comprehensive"],"assays":["foundationone-cdx-panel","foundationone-liquid-cdx","foundationfocus-brca","mychoice-cdx"],"companionDiagnostics":[{"device":"FoundationOne CDx","maker":"Foundation Medicine","companyId":"foundation-medicine","drugs":["olaparib"],"indication":"Ovarian Cancer - Tissue","pma":"P170019/S004 (07/01/2019)","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"},{"device":"FoundationOne CDx","maker":"Foundation Medicine","companyId":"foundation-medicine","drugs":["olaparib"],"indication":"Metastatic Castrate Resistant Prostate Cancer (mCRPC) - Tissue (HRR genes)","pma":"P170019/S015 (05/19/2020)","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"},{"device":"FoundationOne Liquid CDx","maker":"Foundation Medicine","companyId":"foundation-medicine","drugs":["rucaparib"],"indication":"Metastatic Castrate Resistant Prostate Cancer (mCRPC) - Plasma","pma":"P190032 (08/26/2020)","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"},{"device":"FoundationFocus CDxBRCA Assay","maker":"Foundation Medicine","companyId":"foundation-medicine","drugs":["rucaparib"],"indication":"Ovarian Cancer - Tissue","pma":"P160018 (12/19/2016)","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"},{"device":"FoundationOne CDx","maker":"Foundation Medicine","companyId":"foundation-medicine","drugs":["talazoparib","enzalutamide"],"indication":"Metastatic Castrate Resistant Prostate cancer (mCRPC) - Tissue (HRR genes)","pma":"P170019/S060 (05/27/2026)","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"}],"forPatient":"A BRCA mutation found in the tumour opens PARP inhibitor maintenance in ovarian cancer and PARP inhibitor treatment in advanced prostate cancer, whether or not the change is inherited; a follow-up blood test tells you whether it is, which matters for your family. In prostate cancer a wider list of repair genes also counts. If the tumour test was done on blood (ctDNA) and was negative, the labels say tissue should still be tested."},"route":"/biomarkers/brca-somatic/","neighbours":{"biomarker":[{"id":"folr1-expression","kind":"biomarker","name":"Folate receptor alpha expression (FRα-positive, PS2+ >= 75%)","route":"/biomarkers/folr1-expression/"},{"id":"brca-germline","kind":"biomarker","name":"Germline BRCA1/2 pathogenic variant (gBRCAm)","route":"/biomarkers/brca-germline/"},{"id":"hrd-positive","kind":"biomarker","name":"HRD-positive (genomic instability score)","route":"/biomarkers/hrd-positive/"}],"cancer":[{"id":"high-grade-serous-ovarian-cancer","kind":"cancer","name":"High-grade serous ovarian cancer","route":"/cancers/high-grade-serous-ovarian-cancer/"},{"id":"prostate-mcrpc","kind":"cancer","name":"Metastatic castration-resistant prostate cancer","route":"/cancers/prostate-mcrpc/"},{"id":"ovarian","kind":"cancer","name":"Ovarian cancer","route":"/cancers/ovarian/"},{"id":"platinum-sensitive-ovarian-cancer","kind":"cancer","name":"Platinum-sensitive ovarian cancer","route":"/cancers/platinum-sensitive-ovarian-cancer/"}],"drug":[{"id":"foundationone-cdx","kind":"drug","name":"FoundationOne CDx / Liquid CDx","route":"/drugs/foundationone-cdx/"},{"id":"mychoice-cdx","kind":"drug","name":"myChoice CDx","route":"/drugs/mychoice-cdx/"},{"id":"niraparib","kind":"drug","name":"Niraparib","route":"/drugs/niraparib/"},{"id":"olaparib","kind":"drug","name":"Olaparib","route":"/drugs/olaparib/"},{"id":"rucaparib","kind":"drug","name":"Rucaparib","route":"/drugs/rucaparib/"},{"id":"talazoparib","kind":"drug","name":"Talazoparib","route":"/drugs/talazoparib/"}],"term":[{"id":"brca-reversion-mutations","kind":"term","name":"BRCA reversion mutations","route":"/terms/brca-reversion-mutations/"},{"id":"germline-vs-somatic","kind":"term","name":"Germline vs somatic mutations","route":"/terms/germline-vs-somatic/"},{"id":"hrd","kind":"term","name":"Homologous recombination deficiency (HRD)","route":"/terms/hrd/"},{"id":"ngs","kind":"term","name":"Next-generation sequencing (NGS)","route":"/terms/ngs/"}],"target":[{"id":"brca","kind":"target","name":"BRCA1 / BRCA2 (HRD)","route":"/targets/brca/"}]}}