Gene
BRAF
BRAF is a gene biomarker in the evidence tier "FDA companion diagnostic". This page lists evidence by type: FDA companion diagnostic assertions (19), Assay-provider ledger (249), Actionable biomarkers (83), 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 BRAF. 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: 9 with a planned future start and 11 with no date at all.
Publication mentions: plotted from 1990 to 2023, the years our matched corpus covers. Not plotted: 123 at the structurally incomplete recent edge.
The yearly numbers
| Year | Trial mentions | Share of that year | Publication mentions | Share of that year |
|---|---|---|---|---|
| 2026 | 152 of 8,738 | 1.74% | not measured | |
| 2025 | 180 of 8,875 | 2.03% | not measured | |
| 2024 | 165 of 8,597 | 1.92% | not measured | |
| 2023 | 175 of 8,275 | 2.11% | 223 of 11,460 | 1.95% |
| 2022 | 149 of 8,285 | 1.80% | 247 of 13,598 | 1.82% |
| 2021 | 162 of 8,692 | 1.86% | 273 of 15,045 | 1.81% |
| 2020 | 147 of 7,640 | 1.92% | 238 of 14,459 | 1.65% |
| 2019 | 101 of 7,300 | 1.38% | 245 of 12,159 | 2.01% |
| 2018 | 116 of 6,927 | 1.67% | 215 of 11,854 | 1.81% |
| 2017 | 75 of 6,558 | 1.14% | 221 of 11,595 | 1.91% |
Showing 10 of 37 years.
FDA companion diagnostic assertions (19)
Shown in this order: most recent decision first.
| Diagnostic | Source biomarker wording | Manufacturer | Indication | Decision date |
|---|---|---|---|---|
| Guardant360® Liquid CDx | BRAF | Guardant Health, Inc. | Colorectal cancer | 2026-05-19 |
| Guardant360 CDx | BRAF | Guardant Health, Inc. | Colorectal Cancer (CRC) | 2026-01-15 |
| FoundationOne CDx | BRAF | Foundation Medicine, Inc. | Low-Grade Glioma | 2025-01-16 |
| MI Cancer Seek (MCS) | BRAF | Caris Life Sciences | Colorectal Cancer | 2024-11-05 |
| MI Cancer Seek (MCS) | BRAF | Caris Life Sciences | Melanoma | 2024-11-05 |
Showing 5 of 19 companion diagnostic entries.
Assay-provider ledger (249)
Shown in this order: most recent publication first.
| Company | Provider class | Validation | Papers | Most recent publication |
|---|---|---|---|---|
| Clinical Genomics (Colvera) | Diagnostic provider | Clinical validation | 1 | August 15, 2026 |
| DiaCarta | Diagnostic provider | Clinical validation | 1 | August 15, 2026 |
| Freenome | Diagnostic provider | Clinical validation | 1 | August 15, 2026 |
| Guardant Health | Diagnostic provider | Clinical validationAnalytical validation | 4 | August 15, 2026 |
| New Day Diagnostics | Diagnostic provider | Clinical validation | 1 | August 15, 2026 |
Showing 5 of 249 assay-provider companies.
Actionable biomarkers (83)
Shown in this order: fixed catalogue order, not ranked.
| Alteration | Drug | Response | Disease | Source |
|---|---|---|---|---|
| BRAF (V600E,V600D,V600K,V600M,V600G,V600R) | Vemurafenib | response-associated | Erdheim-Chester disease | Cancer Genome Interpreter |
| BRAF (V600E,V600D,V600K,V600M,V600G,V600R) | Vemurafenib | response-associated | Langerhans Cell Histiocytosis | Cancer Genome Interpreter |
| BRAF (V600E) | Vemurafenib | response-associated | astrocytoma | Cancer Genome Interpreter |
| BRAF (V600E) | Plx4720 | response-associated | astrocytoma | Cancer Genome Interpreter |
| BRAF (L485W) | Erk Inhibitors | response-associated | biliary tract neoplasm | Cancer Genome Interpreter |
Showing 5 of 83 actionable-biomarker assertions.
Trial mentions (1,862)
Shown in this order: fixed catalogue order, not by date.
| Trial | Source |
|---|---|
| NCT06990633 | Trial biospecimen (AACT) |
| NCT04050345 | Trial biospecimen (AACT) |
| NCT02251314 | Trial biospecimen (AACT) |
| NCT07391514 | Trial biospecimen (AACT) |
| NCT05365412 | Trial biospecimen (AACT) |
Showing 5 of 1,862 trial mentions.
Target-disease associations (1,004)
Shown in this order: fixed catalogue order, not ranked.
| Disease | Therapeutic area | Source |
|---|---|---|
| ACTH-Producing Pituitary Gland Adenoma | cancer or benign tumor | Literature (Europe PMC) |
| Abnormality of the cardiovascular system | phenotype | Variant curation (ClinVar / EVA) |
| Adamantinomatous Craniopharyngioma | cancer or benign tumor | Cancer Gene Census |
| Adenoid Cystic Breast Carcinoma | cancer or benign tumor | Cancer Gene Census |
| Adenoid Cystic Breast Carcinoma | cancer or benign tumor | Literature (Europe PMC) |
Showing 5 of 1,004 associations.
Vendor sourcing (5,783)
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 | Same nucleotide change resulting in same amino acid change has been previously reported as pathogenic (VCV000040374.2, PMID: 17704260, PS1). The missense var... | View ClinVar record SCV002011970.1 |
| 4SC (Germany) | Trial collaborator | Named in trial exclusion criteriaTrial eligibility criteria | : Distantly metastasized melanoma * Uveal or mucosal melanoma. * History of in-transit metastases within the last 6 months. * No measurable lymph node lesi... | View trial NCT04133948 |
| 4SC (Germany) | Trial collaborator | Mentioned in trial textTrial free-text mention | BRAF | View trial NCT04133948 |
| ABM Therapeutics Corporation | Trial sponsor | Exploratory endpoint in a trialTrial endpoint | Exploratory preliminary efficacy in patients by types of BRAF V600 mutation | View trial NCT04190628 |
| ABM Therapeutics Corporation | Trial sponsor | Named in trial inclusion criteriaTrial eligibility criteria | : 1. Male and female subjects age 18 years and older who are able to sign informed consent and to comply with the protocol 2. Patients with histologically o... | View trial NCT04190628 |
Showing 5 of 5,783 sourcing records.
Trial-cited literature (2,750)
Shown in this order: newest first, then most cited.
| Publication | Journal | Year | Citations |
|---|---|---|---|
| Re-treatment with panitumumab followed by regorafenib versus the reverse sequence in chemorefractory metastatic colorectal cancer patients with RAS and BRAF wild-type circulating tumor DNA: the PARERE study by GONO. | Annals of oncology : official journal of the European Society for Medical Oncology | 2026 | 13 |
| Upfront Modified FOLFOXIRI Plus Panitumumab for <i>RAS/BRAF</i> Wild-Type Metastatic Colorectal Cancer: Final Results of the Phase III TRIPLETE Study. | Journal of clinical oncology : official journal of the American Society of Clinical Oncology | 2026 | 7 |
| Retreatment and rechallenge with BRAF/MEK inhibitors in patients with metastatic melanoma: results from the real-world Spanish Melanoma Registry (GEM-1801). | Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico | 2026 | 3 |
| Exploratory biomarker analysis of RAS/BRAF somatic mutations and gene expression signatures for predicting treatment effects of aflibercept in the velour trial. | NPJ precision oncology | 2026 | 1 |
| Individual Patient Data Meta-Analysis of Consensus Molecular Subtypes as Biomarkers of First-Line Treatment in <i>RAS</i> Wild-Type Metastatic Colorectal Cancer. | Journal of clinical oncology : official journal of the American Society of Clinical Oncology | 2026 | 1 |
Showing 5 of 2,750 papers.
Protein variant mentions (163)
Shown in this order: alphabetical by variant.
| Variant | Distinct papers | Year range | Sample papers |
|---|---|---|---|
| p.A1798G | 1 | 2015 | PMID 26150740 |
| p.A205V | 1 | 2009 | PMID 19718025 |
| p.A2246T | 1 | 2009 | PMID 19718025 |
| p.A246P | 2 | 2015 | PMID 25741868, PMID 26150740 |
| p.A481E | 1 | 2015 | PMID 25741868 |
Showing 5 of 163 variants.
Human sample screening reference (24)
Shown in this order: alphabetical by variant.
| Variant | GDC project | Disease / site | Affected cases | Profiled cases | Observed frequency | 95% interval |
|---|---|---|---|---|---|---|
| p.F468C | TCGA-PRAD | Adenomas and Adenocarcinomas; Cystic, Mucinous and Serous Neoplasms; Acinar Cell Neoplasms; Ductal and Lobular Neoplasms; Prostate gland | 1 | 500 | 0.20% | 0.04% to 1.12% |
| p.G392E | MMRF-COMMPASS | Plasma Cell Tumors; Hematopoietic and reticuloendothelial systems | 1 | 961 | 0.10% | 0.02% to 0.59% |
| p.N581I | CPTAC-3 | Not Applicable; Transitional Cell Papillomas and Carcinomas; Ductal and Lobular Neoplasms; Adenomas and Adenocarcinomas; Gliomas; Epithelial Neoplasms, NOS; Complex Epithelial Neoplasms; Complex Mixed and Stromal Neoplasms; Lipomatous Neoplasms; Squamous Cell Neoplasms; Myeloid Leukemias; Nevi and Melanomas; Stomach; Other and ill-defined sites in lip, oral cavity and pharynx; Unknown; Colon; Other and unspecified urinary organs; Floor of mouth; Other and unspecified parts of mouth; Gum; Bronchus and lung; Oropharynx; Other and unspecified parts of tongue; Base of tongue; Breast; Other and ill-defined sites; Larynx; Lip; Uterus, NOS; Hematopoietic and reticuloendothelial systems; Kidney; Brain; Skin; Pancreas; Tonsil | 1 | 1,815 | 0.06% | 0.01% to 0.31% |
| p.N581I | MP2PRT-ALL | Acute Lymphoblastic Leukemia; Lymphoid Leukemias; Hematopoietic and reticuloendothelial systems | 1 | 1,510 | 0.07% | 0.01% to 0.37% |
| p.N581I | 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% |
Showing 5 of 24 cohort observations.
Literature-extracted relations (1,143)
Shown in this order: chemicals, then diseases.
| Related entity | Kind | Source relation label | Paper | Year |
|---|---|---|---|---|
| CETUXIMAB | Chemical | associate |
Encorafenib, Cetuximab, and mFOLFOX6 in <i>BRAF</i>-Mutated Colorectal Cancer. | 2025 |
| Vemurafenib | Chemical | negative_correlate |
Anti-Programmed Death Ligand 1 Plus Targeted Therapy in Anaplastic Thyroid Carcinoma: A Nonrandomized Clinical Trial. | 2024 |
| CETUXIMAB | Chemical | negative_correlate |
Molecular profiling of BRAF-V600E-mutant metastatic colorectal cancer in the phase 3 BEACON CRC trial. | 2024 |
| Vemurafenib | Chemical | negative_correlate |
Phase II study of vemurafenib in children and young adults with tumors harboring BRAF V600 mutations: NCI-COG pediatric MATCH trial (APEC1621) Arm G. | 2024 |
| Vemurafenib | Chemical | negative_correlate |
Tunlametinib (HL-085) plus vemurafenib in patients with advanced BRAF V600-mutant solid tumors: an open-label, single-arm, multicenter, phase I study. | 2024 |
Showing 5 of 1,143 relation assertions.
Organizations publishing (1,145)
Shown in this order: most papers first.
| Organization | Type | Papers | Years |
|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | Hospital | 209 | 2008 to 2025 |
| The University of Texas System | Academic | 166 | 2008 to 2026 |
| Dana-Farber Cancer Institute | Other | 151 | 2010 to 2025 |
| Government of the United States of America | Government | 114 | 2002 to 2025 |
| Mass General Brigham | Hospital | 112 | 2009 to 2025 |
Showing 5 of 1,145 organizations.
Where BRAF 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
- musculoskeletal or connective tissue disease
- nervous system disease
- nutritional or metabolic disease
- phenotype
- reproductive system or breast disease
- respiratory or thoracic disease
- urinary system disease
726 diseases touched.
Not on this page
Checked, with nothing recorded for this biomarker: fda biomarker qualification projects.