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Título: | Clinical performance evaluation of the Idylla™ EGFR Mutation Test on formalin-fixed paraffin-embedded tissue of non-small cell lung cancer |
Autor: | Delgado-García, Mercedes CSIC ORCID; Weynand, Birgit; Gómez Izquierdo, Lourdes; Hernández, María José; Blanco, Ángela María CSIC; Varela, Mar; Matías-Guiu, Xavier; Nadal, Ernest; Márquez-Lobo, Bélgica; Alarcão, Ana; Álava, Enrique de CSIC ORCID; Biscuola, Michele CSIC ORCID | Palabras clave: | Non-small-cell lung carcinoma EGFR Mutations |
Fecha de publicación: | 3-abr-2020 | Editor: | BioMed Central | Citación: | BMC Cancer 20: 275 (2020) | Resumen: | [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. |
Versión del editor: | http://doi.org/10.1186/s12885-020-6697-7 | URI: | http://hdl.handle.net/10261/235377 | DOI: | 10.1186/s12885-020-6697-7 | Identificadores: | doi: 10.1186/s12885-020-6697-7 e-issn: 1471-2407 |
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