In:
Pathology and Oncology Research, Frontiers Media SA, Vol. 29 ( 2023-1-31)
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.
Type of Medium:
Online Resource
ISSN:
1532-2807
DOI:
10.3389/pore.2023.1610707
DOI:
10.3389/pore.2023.1610707.s001
DOI:
10.3389/pore.2023.1610707.s002
DOI:
10.3389/pore.2023.1610707.s003
Language:
Unknown
Publisher:
Frontiers Media SA
Publication Date:
2023
detail.hit.zdb_id:
2002501-4