cobas® 4800 BRAF V600 Mutation Test

cobas® 4800 BRAD V600 Mutation Test

A companion diagnostic to aid in the selection of melanoma patients for therapy with vemurafenib & cobimetinib

The cobas® 4800 BRAF V600 Mutation Test is a real-time polymerase chain reaction (PCR) test for the detection and identification of BRAF V600 mutations in formalin-fixed paraffin-embedded tissue (FFPET) of human melanoma.

The cobas® 4800 BRAF V600 Mutation Test detects BRAF codon 600 mutation V600E and some non-V600E mutations (V600D, V600E2 and V600K), which represents approximately 90% of all BRAF mutations found in melanoma.1 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. The test is also intended for use with detecting BRAF V600 mutations in papillary thyroid carcinoma (PTC) tissue.*

Specimens are processed using the cobas® DNA Sample Preparation Kit2 to extract DNA from FFPET. Mutation detection is achieved through PCR analysis on the cobas z 480 Analyzer for automated amplification and detection.

Features and benefits3

  • 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
  • In pre-clinical and clinical investigations, the test had >99% accuracy in detecting the BRAF V600E (1799 T>A) mutation,3 which represents >85% of all BRAF mutations reported in the COSMIC database4
  • Detection of V600E mutations at ≥5% mutation level
  • High sensitivity and automated results reporting
  • Time to results in <8 hours
  • Process up to 94 samples in a single run

*not indicated for use in the USA

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

CE-IVD, US-IVD

References

  1. COSMIC database v83 (November 2017)
  2. cobas® DNA Sample Preparation Kit package insert
  3. cobas® 4800 BRAF V600 Mutation Test package insert
  4. Frequency - reported frequency of mutations – COSMIC v51 from 2391 reported skin tumor samples http://www.sangerac.uk/perl/genetics/CGP/cosmic.