ASSAY DESCRIPTION: Mutations in the BRAF gene have been associated with various cancers, including colorectal cancer, malignant melanoma, thyroid carcinoma, NSCL carcinoma, and adenocarcinoma of the lung. The most frequently reported BRAF mutation is an activating missense mutation in which the amino acid glutamic acid is substituted for valine at amino acid position 600 (V600E). The BRAF V600 Mutation assay, performed on the Biocartis Idylla™ System using exclusively FFPE samples (Slides), is an assay for the qualitative detection of V600E/D and V600K/R/M mutations in codon 600 of the BRAF gene. LIMITATIONS: This assay is qualitative and is not intended to detect minimal residual disease. Although this assay detects BRAF V600E, V600K, V600R, V600M, and V600D mutations, it does not distinguish between BRAF mutations occurring on the same nucleotide, i.e., the V600E/D or V600K/R/M mutations. This assay does not detect mutations or alterations in other regions of the BRAF gene. Mutations present below the limit of detection of the assay (1%) might not be detected.
