cobas® 4800 BRAF V600 Mutation Test

cobas® 4800 BRAD V600 Mutation Test

A companion diagnostic for vemurafenib & cobimetinib

The cobas® 4800 BRAF V600 Mutation Test is a real-time PCR assay that detects BRAF V600 mutations in formalin-fixed, paraffin-embedded (FFPET) human tissue. It is designed to help select patients for treatment with vemurafenib alone or in combination with cobimetinib, to treat patients whose melanoma tumours harbour a mutated form of the BRAF gene. Additionally, the test is intended for use with detecting BRAF V600 mutations in papillary thyroid carcinoma (PTC) tissue.

Features and benefits

  • The cobas® 4800 BRAF V600 Mutation Test detects BRAF codon 600 mutation V600E and some non-V600E mutations (V600D, V600E2 and V600K)1, which represents approximately 90% of all BRAF mutations found in melanoma.2
  • The cobas® 4800 BRAF V600 Mutation Test was used in pivotal clinical trials for cobimetinib & vemurafenib, selecting patients whose tumours harboured mutations in the BRAF V600 codon.
  • The cobas® 4800 BRAF V600 Mutation Test is more sensitive in the detection of V600E mutations than Sanger sequencing.3,4
  • In formalin-fixed, paraffin-embedded tissue (FFPET), the cobas® 4800 BRAF V600 Mutation Test can detect V600E mutations at ≥5% mutation level.1
  • The cobas®  4800 BRAF V600 Mutation Test can be performed in <8 hours from receipt of specimen, and up to 94 samples can be processed in a single run.5
Intended use

Intended use

The primary use of the cobas® 4800 BRAF V600 Mutation Test is the detection of the BRAF V600 mutations in DNA extracted from formalin-fixed, paraffin-embedded human melanoma and papillary thyroid carcinoma (PTC) tissue.

In melanoma, it is intended to be used as an aid in selecting patients whose tumors carry BRAF V600 mutations, for treatment either with ZELBORAF® (vemurafenib) alone, or with COTELLIC® (cobimetinib) in combination with ZELBORAF® (vemurafenib).

Registration status


Package inserts

Access package inserts through Roche DiaLog.


1. cobas® 4800 BRAF V600 Mutation Test CE-IVD package insert (2020).

2. COSMIC database v83 (November 2017)

3. Halait, H. Diagn. Mol. Pathol 2012.

4. Bloom et al. Molecular testing for BRAF V600 mutations in the BRIM-2 trial of the BRAF inhibitor vemurafenib (RG7204 PLX4032) in metastatic melanoma, 2011.

5. Lopez-Rios et al. Comparison of molecular testing methods for the detection of BRAF.