TY - JOUR T1 - Idylla <em>EGFR</em> assay on extracted DNA: advantages, limits and place in molecular screening according to the latest guidelines for non-small-cell lung cancer (NSCLC) patients JF - Journal of Clinical Pathology JO - J Clin Pathol DO - 10.1136/jcp-2022-208325 SP - jclinpath-2022-208325 AU - Emmanuel Khalifa AU - Caroline Chapusot AU - Benjamin Tournier AU - Julie Sentis AU - Estelle Marion AU - Alicia Remond AU - Manon Aubry AU - Célia Pioche AU - Anthony Bergeron AU - Charlotte Primois AU - Larry Blanchard AU - Alice Millière AU - Marlène Boucheix AU - Yannick Léger AU - Marine Bairrao AU - Véronique Brouste AU - Laurent Martin AU - Isabelle Soubeyran Y1 - 2022/07/12 UR - http://jcp.bmj.com/content/early/2022/07/11/jcp-2022-208325.abstract N2 - Aims Idylla 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 EGFR on extracted DNA and discuss its place within the global non-small-cell lung cancer (NSCLC) screening strategy.Methods 577 comparative tests between Idylla EGFR on extracted DNA and next-generation sequencing (NGS) were performed across two centres.Results Preanalytical 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 EGFR testing. Due to discordant by design cases, Idylla EGFR sensitivity was 86.9% for currently actionable EGFR mutations. Idylla EGFR specificity was 100% in first-line screening. NGS was always feasible on the same DNA.Conclusion Idylla EGFR on 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 EGFR should be restricted to clinical emergency situations accompanied by NGS.All data relevant to the study are included in the article or uploaded as online supplemental information. ER -