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Clinical performance evaluation of the Idylla™ EGFR Mutation Test on formalin-fixed paraffin-embedded tissue of non-small cell lung cancer
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, choosin...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7126408/ https://www.ncbi.nlm.nih.gov/pubmed/32245434 http://dx.doi.org/10.1186/s12885-020-6697-7 |
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author | 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 |
author_facet | 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 |
author_sort | Delgado-García, Mercedes |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-7126408 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-71264082020-04-10 Clinical performance evaluation of the Idylla™ EGFR Mutation Test on formalin-fixed paraffin-embedded tissue of non-small cell lung cancer 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 BMC Cancer Research Article 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. BioMed Central 2020-04-03 /pmc/articles/PMC7126408/ /pubmed/32245434 http://dx.doi.org/10.1186/s12885-020-6697-7 Text en © The Author(s). 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Research Article 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 Clinical performance evaluation of the Idylla™ EGFR Mutation Test on formalin-fixed paraffin-embedded tissue of non-small cell lung cancer |
title | Clinical performance evaluation of the Idylla™ EGFR Mutation Test on formalin-fixed paraffin-embedded tissue of non-small cell lung cancer |
title_full | Clinical performance evaluation of the Idylla™ EGFR Mutation Test on formalin-fixed paraffin-embedded tissue of non-small cell lung cancer |
title_fullStr | Clinical performance evaluation of the Idylla™ EGFR Mutation Test on formalin-fixed paraffin-embedded tissue of non-small cell lung cancer |
title_full_unstemmed | Clinical performance evaluation of the Idylla™ EGFR Mutation Test on formalin-fixed paraffin-embedded tissue of non-small cell lung cancer |
title_short | Clinical performance evaluation of the Idylla™ EGFR Mutation Test on formalin-fixed paraffin-embedded tissue of non-small cell lung cancer |
title_sort | clinical performance evaluation of the idylla™ egfr mutation test on formalin-fixed paraffin-embedded tissue of non-small cell lung cancer |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7126408/ https://www.ncbi.nlm.nih.gov/pubmed/32245434 http://dx.doi.org/10.1186/s12885-020-6697-7 |
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