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.
*not indicated for use in the USA