cobas® 4800 BRAF V600 Mutation Test

A companion diagnostic for vemurafenib

The cobas® 4800 BRAF V600 Mutation Test detects the BRAF V600E mutation in formalin-fixed, paraffin-embedded (FFPET) human melanoma tissue. It is designed to help select patients for treatment with vemurafenib, an oral medicine designed to treat patients whose melanoma tumors harbor a mutated form of the BRAF gene.

Features and Benefits

  • The cobas® BRAF Mutation Test was used in pivotal clinical trials for vemurafenib, to select patients whose tumors harbor the V600E mutation in the BRAF gene.
  • In pre-clinical and clinical investigations, the cobas® BRAF Mutation Test had 97.3% positive agreement in detecting the BRAF V600E (1799 T>A) mutation, which represents >~85% of all BRAF mutations reported in the COSMIC database.
  • The cobas® BRAF Mutation Test is more sensitive in the detection of V600E mutations than Sanger sequencing.*
  • In formalin-fixed, paraffin-embedded tissue (FFPET), the cobas® BRAF Mutation Test can detect V600E mutations at >5% mutation level.*
  • The test may also detect other V600 mutations such as V600D and V600K.*
  • The cobas® BRAF Mutation Test has a low failure rate and is highly reproducible across operators, reagent lots and testing days.*
  • The cobas® BRAF Mutation Test can be performed in <8 hours from receipt of specimen.
  • Liquid, ready-to-use reagents are provided in the test kit to increase laboratory efficiency.
  • The test kits have >12 months shelf life from date of manufacture and upon opening each reagent maintains open-vial stability for up to 90 days.

 

Intended Use

(FDA-IVD, 07/2011, Doc Rev. 1.0)
The cobas® 4800 BRAF V600 Mutation Test is an in vitrodiagnostic device intended for the qualitative detection of the 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, v2.0, and is intended to be used as an aid in selecting melanoma patients whose tumors carry the BRAF V600E mutation for treatment with vemurafenib.

(CE-IVD, 02/2011, Rev. 1.0)
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 tissue.

*cobas® 4800 BRAF V600 Mutation Test FDA-IVD package insert.