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 tumors harbor 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 (not indicated for use in the USA).

Features and benefits

  • The cobas® 4800 BRAF V600 Mutation Test detects BRAF codon 600 mutation V600E and some none-V600E mutations (V600D, V600E2 and V600K), which represents approximately 90% of all BRAF mutations found in melanoma1
  • The cobas® 4800 BRAF V600 Mutation Test was used in pivotal clinical trials for cobimetinib & vemurafenib, selecting patients whose tumors harbored 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
  • In formalin-fixed, paraffin-embedded tissue (FFPET), the cobas® 4800 BRAF V600 Mutation Test can detect V600E mutations at ≥5% mutation level
  • 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
Intended use

Intended use

The cobas® 4800 BRAF V600 Mutation Test is an in vitro diagnostic device intended for the qualitative detection of BRAF V600E mutation in DNA extracted from formalin-fixed, paraffin-embedded human melanoma tissue. The cobas® 4800 BRAF V600 Mutation Test is a real-time PCR test on the cobas® 4800 System, and is intended to be used as an aid in selecting melanoma patients for treatment with the targeted therapies listed in the table below, in accordance with the approved therapeutic product labeling:

 

 Therapeutic

 Therapeutic

 Indication

 Test Result
 ZELBORAF® (vemurafenib)  BRAF V600E  Mutation Detected

 COTELLIC® (cobimetinib),

 in combination with ZELBORAF® (vemurafenib)

 BRAF V600E or V600K*  Mutation Detected*

 

*Due to cross-reactivity by the cobas® 4800 BRAF V600 Mutation Test, the clinical trial for cobimetinib, in combination with vemurafenib, included some patients whose tumor carried the BRAF V600K mutation.

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

Canada-IVD, CE-IVD, US-IVD

Package inserts

Access package inserts through your country’s Roche Diagnostics Website.

References

 

1. COSMIC database v83 (November 2017)

mrsa infographic link

Understanding BRAF and its role in melanoma

Learn more