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 tumours harbour a mutated form of the BRAF gene. Additionally, the test is intended for use with detecting BRAF V600 mutations in papillary thyroid carcinoma (PTC) tissue.
Access package inserts through Roche DiaLog.
1. cobas® 4800 BRAF V600 Mutation Test CE-IVD package insert (2020).
2. COSMIC database v83 (November 2017)
3. Halait, H. Diagn. Mol. Pathol 2012.
4. Bloom et al. Molecular testing for BRAF V600 mutations in the BRIM-2 trial of the BRAF inhibitor vemurafenib (RG7204 PLX4032) in metastatic melanoma, 2011.
5. Lopez-Rios et al. Comparison of molecular testing methods for the detection of BRAF.