101. 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.
- Author
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Behnke A, Cayre A, De Maglio G, Giannini G, Habran L, Tarsitano M, Chetta M, Cappellen D, Lespagnol A, Le Naoures C, Massazza G, Destro A, Bonzheim I, Rau A, Battmann A, Kah B, Watkin E, and Hummel M
- Subjects
- Humans, Prospective Studies, Real-Time Polymerase Chain Reaction methods, Mutation, ErbB Receptors genetics, DNA Mutational Analysis methods, Carcinoma, Non-Small-Cell Lung genetics, Carcinoma, Non-Small-Cell Lung pathology, Lung Neoplasms diagnosis, Lung Neoplasms genetics, Lung Neoplasms pathology
- Abstract
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., Competing Interests: IB declares receipt of honoraria from Novartis, Bayer, Pfizer, Takeda, AstraZeneca and BMS. EW declares the receipt of honoraria from AstraZeneca and MSD. MH declares membership in advisory councils or committees for AstraZeneca, Roche, Novartis, Pierre Fabre GDM, Sanofi, MSD and BMS; and receipt of grants or funds from AstraZeneca. Author EW was employed by the company CYPATH. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The authors declare that this study received funding from AstraZeneca, Cambridge, UK and Biocartis, Mechelen, Belgium. Biocartis were involved in study design, and analysis and interpretation of data. AstraZeneca were not involved in study design or analysis and interpretation of data. The funders were not involved in collection of data. The funders reviewed the manuscript before submission., (Copyright © 2023 Behnke, Cayre, De Maglio, Giannini, Habran, Tarsitano, Chetta, Cappellen, Lespagnol, Le Naoures, Massazza, Destro, Bonzheim, Rau, Battmann, Kah, Watkin and Hummel.)
- Published
- 2023
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