Gene
BRCA1
BRCA1 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 (98), Actionable biomarkers (12), and 8 more evidence types, each linked to its source.
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Rows recorded per section (log scale)
3 more sections with rows · 1 section 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 BRCA1. 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: 94 at the structurally incomplete recent edge.
The yearly numbers
| Year | Trial mentions | Share of that year | Publication mentions | Share of that year |
|---|---|---|---|---|
| 2026 | 67 of 8,738 | 0.77% | not measured | |
| 2025 | 72 of 8,875 | 0.81% | not measured | |
| 2024 | 75 of 8,597 | 0.87% | not measured | |
| 2023 | 55 of 8,275 | 0.66% | 153 of 11,460 | 1.34% |
| 2022 | 86 of 8,285 | 1.04% | 223 of 13,598 | 1.64% |
| 2021 | 63 of 8,692 | 0.72% | 210 of 15,045 | 1.40% |
| 2020 | 64 of 7,640 | 0.84% | 164 of 14,459 | 1.13% |
| 2019 | 66 of 7,300 | 0.90% | 160 of 12,159 | 1.32% |
| 2018 | 57 of 6,927 | 0.82% | 135 of 11,854 | 1.14% |
| 2017 | 47 of 6,558 | 0.72% | 132 of 11,595 | 1.14% |
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 | BRCA1 | Foundation Medicine, Inc. | Metastatic Castrate Resistant Prostate Cancer (mCRPC) | 2024-08-30 |
| FoundationOne Liquid CDx | BRCA1 | Foundation Medicine, Inc. | Metastatic Castrate Resistant Prostate Cancer (mCRPC) | 2024-08-30 |
| FoundationOne Liquid CDx | BRCA1 | Foundation Medicine, Inc. | Metastatic Castrate Resistant Prostate Cancer (mCRPC) | 2024-06-28 |
| FoundationOne CDx | BRCA1 | Foundation Medicine, Inc. | Prostate Cancer | 2023-08-11 |
| FoundationOne Liquid CDx | BRCA1 | Foundation Medicine, Inc. | Metastatic Castrate Resistant Prostate Cancer (mCRPC) | 2020-11-06 |
Showing 5 of 14 companion diagnostic entries.
Assay-provider ledger (98)
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 98 assay-provider companies.
Actionable biomarkers (12)
Shown in this order: fixed catalogue order, not ranked.
| Alteration | Drug | Response | Disease | Source |
|---|---|---|---|---|
| BRCA1 oncogenic mutation | CISPLATIN | response-associated | breast adenocarcinoma | Cancer Genome Interpreter |
| BRCA1 oncogenic mutation | Veliparib | response-associated | breast adenocarcinoma | Cancer Genome Interpreter |
| BRCA1 oncogenic mutation | Platinum Agent | response-associated | breast adenocarcinoma | Cancer Genome Interpreter |
| BRCA1 oncogenic mutation | OLAPARIB | response-associated | breast adenocarcinoma | Cancer Genome Interpreter |
| BRCA1 oncogenic mutation | Parp Inhibitor + Chemotherapys | response-associated | ovarian carcinoma | Cancer Genome Interpreter |
Showing 5 of 12 actionable-biomarker assertions.
Trial mentions (998)
Shown in this order: fixed catalogue order, not by date.
| Trial | Source |
|---|---|
| NCT05310370 | Trial biospecimen (AACT) |
| NCT00597987 | Trial biospecimen (AACT) |
| NCT07532434 | Trial biospecimen (AACT) |
| NCT02489058 | Trial biospecimen (AACT) |
| NCT03337087 | Trial eligibility (AACT) |
Showing 5 of 998 trial mentions.
Target-disease associations (752)
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 complete gonadal dysgenesis | cardiovascular disease | Mouse knockout (IMPC) |
| 46,XY partial gonadal dysgenesis | endocrine system disease | Mouse knockout (IMPC) |
| Abnormal emotional state | phenotype | Literature (Europe PMC) |
| Alzheimer disease | nervous system disease | Literature (Europe PMC) |
Showing 5 of 752 associations.
Vendor sourcing (3,625)
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 v2.1.1 dataset. This variant was predicted to result in inframe deletion located in a non-repeat region and is pred... | View ClinVar record SCV003842017.1 |
| 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 | BRCA1 | View trial NCT05989022 |
| AGO Research GmbH | Trial sponsor | Named in trial inclusion criteriaTrial eligibility criteria | : 1. All patients must have a pathologically documented, definite diagnosis of epithelial cancer of the ovary, the fallopian tube or the peritoneum 2. Relap... | View trial NCT04274426 |
| AGO Research GmbH | Trial sponsor | Mentioned in trial textTrial free-text mention | BRCA1 | View trial NCT04274426 |
Showing 5 of 3,625 sourcing records.
Trial-cited literature (1,999)
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 |
| Rucaparib maintenance for newly diagnosed advanced ovarian cancer: interim overall survival, progression-free survival, and safety at 5 years of follow-up from the phase III ATHENA-MONO/GOG-3020/ENGOT-ov45 study. | Annals of oncology : official journal of the European Society for Medical Oncology | 2026 | 3 |
| A phase 2 study of orally administered live biotherapeutic salmonella-IL2 with FOLFIRINOX for stage IV pancreatic cancer. | Cancer immunology, immunotherapy : CII | 2026 | 2 |
| 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 |
Showing 5 of 1,999 papers.
Protein variant mentions (753)
Shown in this order: alphabetical by variant.
| Variant | Distinct papers | Year range | Sample papers |
|---|---|---|---|
| p.A1039V | 1 | 2015 | PMID 25741868 |
| p.A1199V | 2 | 2015 to 2016 | PMID 26467025, PMID 25741868 |
| p.A1368V | 2 | 2015 to 2019 | PMID 31131967, PMID 25741868 |
| p.A1416T | 2 | 2015 to 2016 | PMID 26467025, PMID 25741868 |
| p.A1481T | 2 | 2015 to 2016 | PMID 26467025, PMID 25741868 |
Showing 5 of 753 variants.
Human sample screening reference (1)
Shown in this order: alphabetical by variant.
| Variant | GDC project | Disease / site | Affected cases | Profiled cases | Observed frequency | 95% interval |
|---|---|---|---|---|---|---|
| p.S1503* | TCGA-COAD | Epithelial Neoplasms, NOS; Adenomas and Adenocarcinomas; Cystic, Mucinous and Serous Neoplasms; Complex Epithelial Neoplasms; Rectosigmoid junction; Colon | 1 | 461 | 0.22% | 0.04% to 1.22% |
Literature-extracted relations (1,044)
Shown in this order: chemicals, then diseases.
| Related entity | Kind | Source relation label | Paper | Year |
|---|---|---|---|---|
| Platinum | Chemical | negative_correlate |
Genomic and Epigenomic ctDNA Profiling in Liquid Biopsies from Heavily Pretreated Patients with DNA Damage Response-Deficient Tumors. | 2025 |
| Platinum | Chemical | associate |
Olaparib as Treatment Versus Nonplatinum Chemotherapy in Patients With Platinum-Sensitive Relapsed Ovarian Cancer: Phase III SOLO3 Study Final Overall Survival Results. | 2025 |
| Platinum | Chemical | associate |
Tumor-intrinsic chemosensitivity assessed by KELIM and prognosis by BRCA status in patients with advanced ovarian carcinomas. | 2025 |
| Testosterone | Chemical | associate |
Serum testosterone and prostate cancer in men with germline <i>BRCA1/2</i> pathogenic variants. | 2023 |
| Platinum | Chemical | associate |
Efficacy of chemotherapy according to <i>BRCA</i> status in patients with high-grade serous ovarian carcinoma at first platinum-sensitive relapse. | 2023 |
Showing 5 of 1,044 relation assertions.
Organizations publishing (1,033)
Shown in this order: most papers first.
| Organization | Type | Papers | Years |
|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | Hospital | 136 | 2002 to 2026 |
| Dana-Farber Cancer Institute | Other | 119 | 2008 to 2026 |
| Government of the United States of America | Government | 113 | 1995 to 2025 |
| The University of Texas System | Academic | 87 | 2008 to 2025 |
| Mayo Clinic | Hospital | 78 | 2007 to 2024 |
Showing 5 of 1,033 organizations.
Where BRCA1 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
- integumentary system disease
- measurement
- medical procedure
- nervous system disease
- nutritional or metabolic disease
- phenotype
- psychiatric disorder
- reproductive system or breast disease
- respiratory or thoracic disease
620 diseases touched.
Not on this page
Checked, with nothing recorded for this biomarker: fda biomarker qualification projects.