cobas^® 4800 BRAF V600 Mutation Test

A companion diagnostic for ZELBORAF® and COTELLIC®
 

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.

• 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