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Title: | Clinical performance evaluation of the Idylla™ EGFR Mutation Test on formalin-fixed paraffin-embedded tissue of non-small cell lung cancer | Authors: | Delgado-García, Mercedes Weynand, Birgit Gómez-Izquierdo, Lourdes Hernández, María José Blanco, Ángela María Varela, Mar Matias-Guiu, Xavier Nadal, Ernest Márquez-Lobo, Bélgica Alarcão, Ana de Álava, Enrique Biscuola, Michele |
Keywords: | Non-small-cell lung carcinoma; EGFR; Mutations | Issue Date: | 2020 | Publisher: | Springer Nature | Project: | Supported by each clinical center. Biocartis provided free-of-charge Idylla™ EGFR Mutation Test cartridges. | Serial title, monograph or event: | BMC Cancer | Volume: | 20 | Issue: | 1 | 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™ 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. | URI: | https://hdl.handle.net/10316/105823 | ISSN: | 1471-2407 | DOI: | 10.1186/s12885-020-6697-7 | Rights: | openAccess |
Appears in Collections: | FMUC Medicina - Artigos em Revistas Internacionais |
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Clinical-performance-evaluation-of-the-Idylla-EGFR-Mutation-Test-on-formalinfixed-paraffinembedded-tissue-of-nonsmall-cell-lung-cancerBMC-Cancer.pdf | 716.19 kB | Adobe PDF | View/Open |
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