BRCA1
BRCA1 plays a central role in homologous recombination DNA repair. Pathogenic variants are associated with increased cancer risk and predict response to PARP inhibitors in breast, ovarian, prostate, and other cancers.
Where this biomarker is used
Each approval combines this biomarker with a specific indication and therapy. Select a therapy in the tables below to open its FDA-defined testing pathway.
Approvals where BRCA1 is defined directly in the indication labeling.
| Indication | Biomarker criteria | Therapies |
|---|---|---|
Breast Cancer Solid Tumor · Breast |
| |
Metastatic Castrate Resistant Prostate Cancer (mCRPC) Solid Tumor · Prostate |
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Ovarian Cancer Solid Tumor · Ovary |
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Pancreatic Cancer Solid Tumor · Pancreas |
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Prostate Cancer Solid Tumor · Prostate |
|
Approvals defined at the solid tumor level where BRCA1 is part of the eligibility criteria.
No tumor-agnostic approvals are currently mapped for this biomarker.
Tests that measure this biomarker
These assays report BRCA1 as part of their validated menu. In many cases they are identified in FDA labeling as acceptable companion diagnostics for specific approvals.
Reports BRCA1 as part of its biomarker panel.
Reports BRCA1 as part of its biomarker panel.
Reports BRCA1 as part of its biomarker panel.