Rapid EGFR mutation testing in lung cancer tissue samples using a fully automated system and single-use cartridge.

摘要: Abstract Introduction Activating mutations in the tyrosine kinase domain of epidermal growth factor receptor (EGFR) gene non-small cell lung cancer (NSCLC) patients predicts response to EGFR inhibitors (TKIs). The Idylla™ system (Biocartis, Mechelen, Belgium) is a fully integrated, cartridge-based platform that provides automated sample processing and real-time PCR-based mutation detection single-use cartridge. This study evaluated Mutation Assay cartridges against next-generation sequencing (NGS) using formalin fixed, paraffin embedded (FFPE) tissue samples. Methods Thirty-four FFPE adenocarcinoma samples were tested on system. 21 had at least one 13 no as determined by NGS analysis Ion AmpliSeq 50-gene Cancer Hotspot Panel v2 (Thermo Fisher Scientific). One 10 ​μm section was used for each test all cases met minimum tumor content requirement (≥10%). Results results complete agreement with those obtained targeted Idylla™. identified two additional are not (E709V V774M). No detected having wild-type EGFR. Conclusion offers rapid reliable testing clinically actionable directly from sections. Its simplicity ease use compared other available molecular techniques make it suitable routine clinical variety settings.