TY - JOUR AU - Behnke, Anke AU - Cayre, Anne AU - De Maglio, Giovanna AU - Giannini, Giuseppe AU - Habran, Lionel AU - Tarsitano, Marina AU - Chetta, Massimiliano AU - Cappellen, David AU - Lespagnol, Alexandra AU - Le Naoures, Cecile AU - Massazza, Gabriella AU - Destro, Annarita AU - Bonzheim, Irina AU - Rau, Achim AU - Battmann, Achim AU - Kah, Bettina AU - Watkin, Emmanuel AU - Hummel, Michael PY - 2023 M3 - Original Research TI - FACILITATE: A real-world, multicenter, prospective study investigating the utility of a rapid, fully automated real-time PCR assay versus local reference methods for detecting epidermal growth factor receptor variants in NSCLC JO - Pathology and Oncology Research UR - https://www.por-journal.com/articles/10.3389/pore.2023.1610707 VL - 29 SN - 1532-2807 N2 - Accurate testing for epidermal growth factor receptor (EGFR) variants is essential for informing treatment decisions in non-small cell lung cancer (NSCLC). Automated diagnostic workflows may allow more streamlined initiation of targeted treatments, where appropriate, while comprehensive variant analysis is ongoing. FACILITATE, a real-world, prospective, multicenter, European study, evaluated performance and analytical turnaround time of the Idylla™ EGFR Mutation Test compared with local reference methods. Sixteen sites obtained formalin-fixed paraffin-embedded biopsy samples with ≥ 10% neoplastic cells from patients with NSCLC. Consecutive 5 μm sections from patient samples were tested for clinically relevant NSCLC-associated EGFR variants using the Idylla™ EGFR Mutation Test and local reference methods; performance (concordance) and analytical turnaround time were compared. Between January 2019 and November 2020, 1,474 parallel analyses were conducted. Overall percentage agreement was 97.7% [n = 1,418; 95% confidence interval (CI): 96.8–98.3], positive agreement, 87.4% (n = 182; 95% CI: 81.8–91.4) and negative agreement, 99.2% (n = 1,236; 95% CI: 98.5–99.6). There were 38 (2.6%) discordant cases. Ninety percent of results were returned with an analytical turnaround time of within 1 week using the Idylla™ EGFR Mutation Test versus ∼22 days using reference methods. The Idylla™ EGFR Mutation Test performed well versus local methods and had shorter analytical turnaround time. The Idylla™ EGFR Mutation Test can thus support application of personalized medicine in NSCLC. ER -