Multi-Center Evaluation of the Fully Automated PCR-Based Idylla EGFR Mutation Assay on Formalin-Fixed, Paraffin-Embedded Tissue of Human Lung Cancer

Before initiating treatment of advanced non–small-cell lung cancer with tyrosine kinase inhibitors (eg, erlotinib, gefitinib, osimertinib, afatinib), which inhibit the catalytic activity of epidermal growth factor receptor (EGFR), clinical guidelines require determining the EGFR mutational status for activating (EGFR exons 18, 19, 20, or 21) and resistance mutations (EGFR exon 20). The EGFR resistance mutation T790M should be monitored at cancer progression. The Idylla EGFR Mutation Assay performed on the Idylla molecular diagnostics platform is a fully automated (