CE-IVD
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.
CE-IVD
Access package inserts through Roche DiaLog.
References
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.