ASSAY DESCRIPTION: BRAF V600 mutations are associated with sensitivity to BRAF inhibitors while NRAS mutations have a prognostic value. The NRAS/BRAF Mutation assay, performed on the Biocartis Idylla™ System using exclusively FFPE samples (Slides), combines the detection of mutations in codons 12, 13, 59, 61, 117, 146 of the NRAS gene, and mutations in codon 600 (V600E/D/K/R) of the BRAF gene. LIMITATIONS: This assay is qualitative and is not intended to detect minimal residual disease. The assay does not distinguish between some variants for NRAS G13 (G13R/V), NRAS G12 (G12 A/V) and NRAS A146 (A146T/V). While the assay detects BRAF V600E, V600K, V600R and V600D mutations it does not distinguish between the different variant occurring on the same nucleotide, i.e. the V600E/D or V600K/R mutations. Mutations present below the limit of detection of the assay (5%) might not be detected
