Gene
BRCA2
BRCA2 is a gene biomarker in the evidence tier "FDA companion diagnostic". This page lists evidence by type: FDA companion diagnostic assertions (14), Assay-provider ledger (79), Actionable biomarkers (12), and 7 more evidence types, each linked to its source.
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Rows recorded per section (log scale)
2 more sections with rows · 2 sections measured, none recorded
FDA companion diagnostic
Evidence over time
Share of that year: what fraction of the trials and papers our biomarker dictionary matched in a year mention BRCA2. The denominator is documents that mention any gene, not every registered document, so improving the matcher moves both halves and never rewrites history. Gene named in free-text trial records. A mention, not a validated biomarker. Actionable-biomarker and target-disease-association evidence carries no date in our sources, so it is not on this chart. Publication mentions cover only papers cited by a registered clinical trial, not all of PubMed.
Trial mentions: plotted from 1990 to 2026, the years our matched corpus covers. Not plotted: 3 with a planned future start and 2 with no date at all.
Publication mentions: plotted from 1990 to 2023, the years our matched corpus covers. Not plotted: 49 at the structurally incomplete recent edge.
The yearly numbers
| Year | Trial mentions | Share of that year | Publication mentions | Share of that year |
|---|---|---|---|---|
| 2026 | 31 of 8,738 | 0.35% | not measured | |
| 2025 | 31 of 8,875 | 0.35% | not measured | |
| 2024 | 42 of 8,597 | 0.49% | not measured | |
| 2023 | 25 of 8,275 | 0.30% | 106 of 11,460 | 0.92% |
| 2022 | 46 of 8,285 | 0.56% | 141 of 13,598 | 1.04% |
| 2021 | 37 of 8,692 | 0.43% | 141 of 15,045 | 0.94% |
| 2020 | 32 of 7,640 | 0.42% | 104 of 14,459 | 0.72% |
| 2019 | 40 of 7,300 | 0.55% | 128 of 12,159 | 1.05% |
| 2018 | 41 of 6,927 | 0.59% | 92 of 11,854 | 0.78% |
| 2017 | 24 of 6,558 | 0.37% | 88 of 11,595 | 0.76% |
Showing 10 of 37 years.
FDA companion diagnostic assertions (14)
Shown in this order: most recent decision first.
| Diagnostic | Source biomarker wording | Manufacturer | Indication | Decision date |
|---|---|---|---|---|
| FoundationOne CDx | BRCA2 | Foundation Medicine, Inc. | Metastatic Castrate Resistant Prostate Cancer (mCRPC) | 2024-08-30 |
| FoundationOne Liquid CDx | BRCA2 | Foundation Medicine, Inc. | Metastatic Castrate Resistant Prostate Cancer (mCRPC) | 2024-08-30 |
| FoundationOne Liquid CDx | BRCA2 | Foundation Medicine, Inc. | Metastatic Castrate Resistant Prostate Cancer (mCRPC) | 2024-06-28 |
| FoundationOne CDx | BRCA2 | Foundation Medicine, Inc. | Prostate Cancer | 2023-08-11 |
| FoundationOne Liquid CDx | BRCA2 | Foundation Medicine, Inc. | Metastatic Castrate Resistant Prostate Cancer (mCRPC) | 2020-11-06 |
Showing 5 of 14 companion diagnostic entries.
Assay-provider ledger (79)
Shown in this order: most recent publication first.
| Company | Provider class | Validation | Papers | Most recent publication |
|---|---|---|---|---|
| BIO-RAD Laboratories S.A. (trypan blue) | Reagent supplier | Analytical validation | 1 | May 18, 2026 |
| Fred Hutchinson Cancer Center | Not a company | Analytical validation | 1 | May 18, 2026 |
| JBS Biosciences | Reagent supplier | Analytical validation | 1 | May 18, 2026 |
| LGC Clinical Diagnostics | Reagent supplier | Analytical validation | 1 | May 18, 2026 |
| National Institute of Standards and Technology | Not a company | Analytical validation | 2 | May 18, 2026 +1 undated |
Showing 5 of 79 assay-provider companies.
Actionable biomarkers (12)
Shown in this order: fixed catalogue order, not ranked.
| Alteration | Drug | Response | Disease | Source |
|---|---|---|---|---|
| BRCA2 oncogenic mutation | Platinum Agent | response-associated | breast adenocarcinoma | Cancer Genome Interpreter |
| BRCA2 oncogenic mutation | Veliparib | response-associated | breast adenocarcinoma | Cancer Genome Interpreter |
| BRCA2 oncogenic mutation | CISPLATIN | response-associated | breast adenocarcinoma | Cancer Genome Interpreter |
| BRCA2 oncogenic mutation | OLAPARIB | response-associated | breast adenocarcinoma | Cancer Genome Interpreter |
| BRCA2 oncogenic mutation | Pd1 Ab Inhibitors | response-associated | cutaneous melanoma | Cancer Genome Interpreter |
Showing 5 of 12 actionable-biomarker assertions.
Trial mentions (562)
Shown in this order: fixed catalogue order, not by date.
| Trial | Source |
|---|---|
| NCT07532434 | Trial biospecimen (AACT) |
| NCT00165152 | Trial eligibility (AACT) |
| NCT05834582 | Trial eligibility (AACT) |
| NCT01506609 | Trial eligibility (AACT) |
| NCT07814365 | Trial eligibility (AACT) |
Showing 5 of 562 trial mentions.
Target-disease associations (818)
Shown in this order: fixed catalogue order, not ranked.
| Disease | Therapeutic area | Source |
|---|---|---|
| 46,XX testicular disorder of sex development | endocrine system disease | Mouse knockout (IMPC) |
| 46,XY partial gonadal dysgenesis | endocrine system disease | Mouse knockout (IMPC) |
| APC-related attenuated familial adenomatous polyposis | cancer or benign tumor | Mouse knockout (IMPC) |
| Abruptio Placentae | pregnancy or perinatal disease | GWAS credible sets |
| Absence of circulating granulocytes | phenotype | gene burden |
Showing 5 of 818 associations.
Vendor sourcing (2,094)
Shown in this order: alphabetical by organization.
| Organization | Role | Tier | Evidence | Citation |
|---|---|---|---|---|
| 3billion, Inc. (South Korea) | Testing lab / CRO (runs the assay) | Clinical-testing interpretation submitted (ClinVar)ClinVar clinical-testing submission | The variant is not observed in the gnomAD v4.1.0 dataset. Predicted Consequence/Location: Frameshift: predicted to result in a loss or disruption of normal p... | View ClinVar record SCV006582036.1 |
| 858 Therapeutics, Inc. | Trial sponsor | Named in trial inclusion criteriaTrial eligibility criteria | : * Males and females of age ≥ 18 years at the time of signing the informed consent document. * Histologically or cytologically confirmed advanced (incurabl... | View trial NCT06395519 |
| 858 Therapeutics, Inc. | Trial sponsor | Mentioned in trial textTrial free-text mention | BRCA2 | View trial NCT06395519 |
| AB-CT - Advanced Breast-CT GmbH | Trial sponsor | Named in trial exclusion criteriaTrial eligibility criteria | : 1. Known pregnancy or breastfeeding 2. Presence of BRCA1 or BRCA2 allele 3. Insufficient renal function (MDRD) 4. Dysfunction of the thyroid gland (TSH de... | View trial NCT05989022 |
| AB-CT - Advanced Breast-CT GmbH | Trial sponsor | Mentioned in trial textTrial free-text mention | BRCA2 | View trial NCT05989022 |
Showing 5 of 2,094 sourcing records.
Trial-cited literature (1,348)
Shown in this order: newest first, then most cited.
| Publication | Journal | Year | Citations |
|---|---|---|---|
| TBCRC 048 (Olaparib Expanded) Expansion Cohorts: Phase II Study of Olaparib Monotherapy for Patients With Metastatic Breast Cancer With Germline Mutations in <i>PALB2</i> or Somatic Mutations in <i>BRCA1</i> or <i>BRCA2</i>. | Journal of clinical oncology : official journal of the American Society of Clinical Oncology | 2026 | 3 |
| Probe-Based Confocal Laser Endomicroscopy in Gynecologic Surgical Oncology: Intraoperative Insights to Guide Surgical Resection. | Annals of surgical oncology | 2026 | 0 |
| Assessment of a Polygenic Risk Score in Screening for Prostate Cancer. | The New England journal of medicine | 2025 | 84 |
| Niraparib and abiraterone acetate plus prednisone for HRR-deficient metastatic castration-sensitive prostate cancer: a randomized phase 3 trial. | Nature medicine | 2025 | 45 |
| Association between risk-reducing surgeries and survival in young BRCA carriers with breast cancer: an international cohort study. | The Lancet. Oncology | 2025 | 44 |
Showing 5 of 1,348 papers.
Protein variant mentions (1,604)
Shown in this order: alphabetical by variant.
| Variant | Distinct papers | Year range | Sample papers |
|---|---|---|---|
| p.A1162T | 1 | 2015 | PMID 25741868 |
| p.A1162V | 1 | 2015 | PMID 25741868 |
| p.A1170V | 2 | 2015 to 2016 | PMID 26467025, PMID 25741868 |
| p.A1193V | 1 | 2015 | PMID 25741868 |
| p.A1233T | 2 | 2015 to 2016 | PMID 26467025, PMID 25741868 |
Showing 5 of 1,604 variants.
Literature-extracted relations (715)
Shown in this order: chemicals, then diseases.
| Related entity | Kind | Source relation label | Paper | Year |
|---|---|---|---|---|
| BEVACIZUMAB | Chemical | associate |
Homologous Recombination Repair Gene Mutations to Predict Olaparib Plus Bevacizumab Efficacy in the First-Line Ovarian Cancer PAOLA-1/ENGOT-ov25 Trial. | 2023 |
| Progesterone | Chemical | associate |
Antiprogestins reduce epigenetic field cancerization in breast tissue of young healthy women. | 2022 |
| Platinum | Chemical | associate |
Systemic Therapy for Metastatic Pancreatic Cancer. | 2021 |
| Platinum | Chemical | associate |
Phase II trial of veliparib and temozolomide in metastatic breast cancer patients with and without BRCA1/2 mutations. | 2021 |
| CARBOPLATIN | Chemical | associate |
Assessment of structural chromosomal instability phenotypes as biomarkers of carboplatin response in triple negative breast cancer: the TNT trial. | 2021 |
Showing 5 of 715 relation assertions.
Organizations publishing (903)
Shown in this order: most papers first.
| Organization | Type | Papers | Years |
|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | Hospital | 99 | 2002 to 2026 |
| Government of the United States of America | Government | 82 | 1997 to 2024 |
| Dana-Farber Cancer Institute | Other | 76 | 2012 to 2026 |
| The University of Texas System | Academic | 65 | 2008 to 2023 |
| Mayo Clinic | Hospital | 55 | 2007 to 2024 |
Showing 5 of 903 organizations.
Where BRCA2 appears
- biological_process
- cancer or benign tumor
- cardiovascular disease
- disorder of visual system
- endocrine system disease
- gastrointestinal disease
- genetic, familial or congenital disease
- hematologic disease
- immune system disease
- infectious disease
- injury, poisoning or other complication
- integumentary system disease
- measurement
- medical procedure
- nervous system disease
- nutritional or metabolic disease
- phenotype
- pregnancy or perinatal disease
- reproductive system or breast disease
- respiratory or thoracic disease
- urinary system disease
597 diseases touched.
Not on this page
Checked, with nothing recorded for this biomarker: fda biomarker qualification projects and human sample screening reference.