Use of the Idylla EGFR Mutation Test for Variant Detection in Non–Small Cell Lung Cancer Samples

Abstract

Abstract Objectives Stratified management of patients with non–small cell lung carcinoma (NSCLC) through epithelial growth factor receptor (EGFR) variant analysis has become standard clinical practice. The Idylla system is a fully compliant European in vitro diagnostics device, a fully automated platform designed to rapidly genotype formalin-fixed paraffin-embedded tissue samples. This retrospective study aims to validate the Idylla EGFR Mutation Test for use with extracted DNA from known NSCLC samples. Methods In this study, 20 µL of archival extracted DNA was placed directly inside the Idylla EGFR assay single-use cartridge. Idylla results were compared with the original Sanger sequencing reference method. Results The Idylla EGFR Mutation Test yielded valid results for all samples tested, confirming the variants identified by the reference method that lay within the Idylla target range. No false-positive cases were noted with the Idylla assay. Variant genotype reports were obtained within 150 minutes. Conclusions The Idylla EGFR assay is sensitive for extracted DNA and can be reliably applied to cytologic specimens, enabling its implementation as an ancillary first-line test for patients with NSCLC.