Delgado-Garcia, MercedesWeynand, BirgitGomez-Izquierdo, LourdesHernandez, Maria JoseBlanco, Angela MariaVarela, MarMatias-Guiu, XavierNadal, ErnestMarquez-Lobo, BelgicaAlarcão, Anade Alava, EnriqueBiscuola, Michele2023-02-082023-02-082020-04-03Delgado-García M, Weynand B, Gómez-Izquierdo L, Hernández MJ, Blanco ÁM, Varela M, et al. Clinical performance evaluation of the Idylla™ EGFR Mutation Test on formalin-fixed paraffin-embedded tissue of non-small cell lung cancer. BMC Cancer. 2020 Apr 3;20(1):275http://hdl.handle.net/10668/15321Detection 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. 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). 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%. The Idylla™ EGFR Mutation Test passed its clinical validity performance characteristics for accuracy.enAttribution 4.0 Internationalhttp://creativecommons.org/licenses/by/4.0/EGFRMutationsNon-small-cell lung carcinomaAdultAgedAged, 80 and overBiopsyCarcinoma, Non-Small-Cell LungDNA Mutational AnalysisErbB ReceptorsFemaleFormaldehydeHumansLung NeoplasmsMaleMiddle AgedMolecular Diagnostic TechniquesMutationParaffin Embeddingresearch article32245434open accessAdhesión en parafinaAnálisis mutacional de ADNBiopsiaNeoplasias pulmonares10.1186/s12885-020-6697-71471-2407PMC7126408https://bmccancer.biomedcentral.com/counter/pdf/10.1186/s12885-020-6697-7https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7126408/pdf