ASSAY DESCRIPTION: The epidermal growth factor receptor (EGFR) signaling pathway is frequently activated in human cancers including non-small cell lung adenocarcinoma (NSCLC) and colorectal carcinoma (CRC). Mutations in EGFR biomarker have diagnostic and prognostic value and determine the choice of treatment. This qualitative assay, performed on the Biocartis Idylla™ System using exclusivelly FFPE samples (Slides), detects 51 EGFR mutations: Point mutations in Exon 18 (G719A/C/S), 36 deletions in exon 19, Point mutations in Exon 20 (T790M, S768I), 5 insertions in exon 20 and point mutations in exon 21 (L858R, L861Q) of the EGFR oncogene. LIMITATIONS: This assay is qualitative and is not intended to detect minimal residual diseas. The assay detects G719A, G719C and G719S mutations but does not distinguish between each variant. Any of the 3 mutations will be reported as G719A/C/S. The assay relies on primers designed to detect specific deletions in Exon 19, and insertions in Exon 20. While most are covered by the assay, some, not covered by the primers, might not be detected. Mutations present below the limit of detection of the assay (5%) might not be detected.
