ASSAY DESCRIPTION: Kras mutations are detected in different cancers and can predict the response to EGFR inhibitors and guide patient treatment. This qualitative assay, performed on the Biocartis Idylla™ System using exclusively FFPE samples (Slides), detects 21 KRAS mutations in Codons 12, 13, 59, 61, 117 and 146 and does not detect mutations or alterations in other regions of the KRAS gene. LIMITATIONS: This assay is qualitative and is not intended to detect minimal residual disease. While covering codons 59 and 117, the assay does not distinguish between mutations occurring on the same nucleotide, i.e., A59E/G/T and A146P/T/V respectively. This assay is designed to detect Q61L (c.182A>T) mutation. Other rare or complex Q61L mutations might not be detected, except for Q61L 182_183AA>TT which is interpreted by the assay as a Q61H mutation. Mutations present below the limit of detection of the assay (5%) might not be detected.
