cobas^® 4800 BRAF V600 Mutation Test

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.

• 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
  

CE-IVD, US-IVD