Regulatory Status: CE-IVD, LDT
Detection of BRAF V600E and V600K mutations from FFPE section.
BRAF is an oncogene activated in approximately 8% of all cancers, and in approximately 50% of all melanomas. About 90% of these mutations occur at codon 600, majority V600E mutations. Other mutations at this codon include V600K, V600D and V600M.
With the availability of BRAF inhibitors such as vemurafenib and dabrafenib, and MEK inhibitor trametinib, ESMO now recommends that colorectal cancer and melanoma patients be tested for BRAF V600 mutations. (ESMO also recommends that melanoma patients be tested for NRAS and c-KIT mutations.)
Cutaneous Melanoma: ESMO Clinical Practice Guidelines, Dummer et. al. 2015. Ann Oncol 26 (suppl 5): v126-v132.
ESMO Consensus Guidelines for the Management of Patients with Metastatic Colorectal Cancer, Cutsem et. al. 2016. Ann Oncol 27 (8): 1386–1422