부산대학교 도서관

AimsIdylla epidermal growth factor receptor (EGFR) is a fast and fully automated mutation assay that is easy to implement. However, under the Biocartis-recommended technical conditions, tissue sections are directly introduced into the cartridge, at the risk of exhausting the tumour sample. In this study, we evaluate the performance of Idylla EGFRon extracted DNA and discuss its place within the global non-small-cell lung cancer (NSCLC) screening strategy.Methods577 comparative tests between Idylla EGFRon extracted DNA and next-generation sequencing (NGS) were performed across two centres.ResultsPreanalytical thresholds were established (20% tumour cell content, 50 ng DNA input) and challenged prospectively in routine practice. 16.8% of samples referred for screening were considered non eligible for Idylla EGFRtesting. Due to discordant by design cases, Idylla EGFRsensitivity was 86.9% for currently actionable EGFRmutations. Idylla EGFRspecificity was 100% in first-line screening. NGS was always feasible on the same DNA.ConclusionIdylla EGFRon extracted DNA is feasible and enables tumour material to be saved compared with tissue section use. It is not necessary to replace the analytical thresholds of the Biocartis algorithm. Due to both the limits of the mutational repertoire and the high increase of targetable genes in NSCLC, the use of Idylla EGFRshould be restricted to clinical emergency situations accompanied by NGS.