BRCA2

Biomarker

BRCA2 is critical for DNA double-strand break repair via homologous recombination. Alterations are clinically relevant for cancer risk assessment and therapeutic selection, particularly for PARP inhibitor therapy.

Approvals
13
Indications
5
Therapies
5
Mapped tests
3

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.

Indication-specific approvals

Approvals where BRCA2 is defined directly in the indication labeling.

IndicationBiomarker criteriaTherapies
Breast Cancer
Solid Tumor · Breast
  • alterations (including mutations)
Metastatic Castrate Resistant Prostate Cancer (mCRPC)
Solid Tumor · Prostate
  • alterations (including mutations)
Ovarian Cancer
Solid Tumor · Ovary
  • alterations (including mutations)
Pancreatic Cancer
Solid Tumor · Pancreas
  • alterations (including mutations)
Prostate Cancer
Solid Tumor · Prostate
  • alterations (including mutations)
Tumor-agnostic approvals

Approvals defined at the solid tumor level where BRCA2 is part of the eligibility criteria.

No tumor-agnostic approvals are currently mapped for this biomarker.

Tests that measure this biomarker

These assays report BRCA2 as part of their validated menu. In many cases they are identified in FDA labeling as acceptable companion diagnostics for specific approvals.

Test
BRACAnalysis CDx
Myriad Genetics
Method
PCR
Specimen
Whole blood

Reports BRCA2 as part of its biomarker panel.

Test
FoundationOne CDx
Foundation Medicine, Inc.
Method
NGS
Specimen
Tissue (FFPE)

Reports BRCA2 as part of its biomarker panel.

Test
FoundationOne Liquid CDx
Foundation Medicine, Inc.
Method
NGS
Specimen
Whole blood

Reports BRCA2 as part of its biomarker panel.

This view is scoped to BRCA2. You can also see how it compares with other biomarkers and indications on the Know Your Companions™ map.