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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™  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™ EGFR Mutation Test on the Idylla™ System.    Methods   EGFR  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).    Results  The 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%.    Conclusions  The Idylla™  EGFR  Mutation Test passed its clinical validity performance characteristics for accuracy.

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