Clinical performance evaluation of the Idylla (TM) EGFR Mutation Test on formalin-fixed paraffin-embedded tissue of non-small cell lung cancer

Abstract

Background: Detection 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 with tyrosine kinase inhibitors in EGFR-mutated patients. Therefore, choosing a suitable technique to test 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 (TM) EGFR Mutation Test is a simple, fast and reliable method designed for the detection of EGFR mutations from formalin-fixed paraffin-embedded samples. The aim of this study was the Clinical Performace Evaluation of the Idylla (TM) EGFR Mutation Test on the Idylla (TM) System. Methods: EGFR mutational status was determined on 132 archived formalin-fixed paraffin-embedded tissue sections with Idylla (TM) technology. Results: were compared with the results previously obtained by routine method in the reference lab (Therascreen (R) EGFR RGQ PCR v2, Qiagen in Molecular Pathology lab, Hospital Universitario Virgen del Rocio de Sevilla). Results: The overall agreement between results obtained with the Idylla (TM) 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%. Conclusions: The Idylla (TM) EGFR Mutation Test passed its clinical validity performance characteristics for accuracy.