BRAF

Biomarker

BRAF is a serine/threonine kinase involved in the MAPK signaling pathway. Activating mutations, particularly V600 alterations, are actionable drivers in melanoma, colorectal cancer, and other solid tumors.

Approvals
24
Indications
6
Therapies
9
Mapped tests
6

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 BRAF is defined directly in the indication labeling.

IndicationBiomarker criteriaTherapies
Anaplastic Thyroid Cancer (ATC)
Solid Tumor · Thyroid
  • V600E
Colorectal Cancer (CRC)
Solid Tumor · Colorectal
  • V600E
Low-Grade Glioma
Solid Tumor · Brain
  • V600 and BRAF fusions
Melanoma
Solid Tumor · Melanoma
  • V600E and V600K
  • V600E
  • V600E or V600K
  • V600
Metastatic Colorectal Cancer (mCRC)
Solid Tumor · Colorectal
  • V600E
Non-Small Cell Lung Cancer (NSCLC)
Solid Tumor · Lung
  • V600E
Tumor-agnostic approvals

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

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

Tests that measure this biomarker

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

Test
cobas 4800 BRAF V600 Mutation Test
Roche Molecular Systems, Inc.
Method
PCR
Specimen
Tissue (FFPE)

Reports BRAF as part of its biomarker panel.

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

Reports BRAF as part of its biomarker panel.

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

Reports BRAF as part of its biomarker panel.

Test
MI Cancer Seek (MCS)
Caris Life Sciences
Method
NGS
Specimen
Tissue (FFPE)

Reports BRAF as part of its biomarker panel.

Test
Oncomine Dx Target Test
Life Technologies Corporation
Method
NGS
Specimen
Tissue (FFPE)

Reports BRAF as part of its biomarker panel.

Test
therascreen BRAF V600E RGQ PCR Kit
QIAGEN GmbH
Method
PCR
Specimen
Tissue (FFPE)

Reports BRAF as part of its biomarker panel.

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