Clinical performance evaluation of the Idylla™ EGFR mutation test on formalin-fixed paraffin-embedded tissue of non-small cell lung cancer

Abstract

BackgroundDetection of epidermal growth factor receptor ( EGFR) mutations in exons 18-21 is recommended in all patients with advanced Non-small-cell lung carcinoma due to the demonstrated efficiency of the standard therapy tyrosine kinase inhibitors in EGFR -mutated patients. Therefore, choosing a suitable technique for testing EGFR mutational status is crucial to warrant a valid result in a short turnaround time using the lowest possible amount of tissue material. The Idylla™ EGFR Mutation Test is a simple, fast and reliable method designed for the detection of EGFR mutations from formalin-fixed paraffin-embedded sample. The aim of this study was the evaluation of the Idylla™ EGFR Mutation Test on the Idylla™ System conducting a Clinical Performance Evaluation.MethodsEGFR mutational status was determined on 132 archived formalin-fixed paraffin-embedded tissue sections with Idylla™ technology. Results were compared with the results previously obtained by routine method in the reference lab (Therascreen ® EGFR RGQ PCR v2, Qiagen in Molecular Pathology lab, Hospital Universitario Virgen del Rocío de Sevilla)ResultsThe overall agreement between results obtained with the Idylla™ EGFR Mutation Test and the Comparator test method was 95.38% (with 1-sided 95% lower limit of 91.7%) showing Positive Diagnostic Agreement of 93.22% and Negative Diagnostic Agreement of 97.18%, with a Limit Of Detection ≤5%.ConclusionsThe Idylla™ EGFR Mutation Test passed its clinical validity performance characteristics for accuracy.