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, choosi...

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Authors: Delgado-García, Mercedes, Weynand, Birgit, Gómez Izquierdo, Lourdes, Hernández, María José, Blanco, Ángela María, Varela, Mar, Matías-Guiu, Xavier, Nadal, Ernest, Márquez-Lobo, Bélgica, Alarcão, Ana, Álava, Enrique de, Biscuola, Michele
Format: article
Status:Published version
Publication Date:2020
Country:España
Institution:Consejo Superior de Investigaciones Científicas (CSIC)
Repository:DIGITAL.CSIC. Repositorio Institucional del CSIC
OAI Identifier:oai:digital.csic.es:10261/235377
Online Access:http://hdl.handle.net/10261/235377
Access Level:Open access
Keyword:Non-small-cell lung carcinoma
EGFR
Mutations
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spelling Clinical performance evaluation of the Idylla™ EGFR Mutation Test on formalin-fixed paraffin-embedded tissue of non-small cell lung cancerDelgado-García, MercedesWeynand, BirgitGómez Izquierdo, LourdesHernández, María JoséBlanco, Ángela MaríaVarela, MarMatías-Guiu, XavierNadal, ErnestMárquez-Lobo, BélgicaAlarcão, AnaÁlava, Enrique deBiscuola, MicheleNon-small-cell lung carcinomaEGFRMutations[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.Supported by each clinical center. Biocartis provided free-of-charge Idylla™ EGFR Mutation Test cartridges.BioMed CentralConsejo Superior de Investigaciones Científicas [https://ror.org/02gfc7t72]2021202120202021info:eu-repo/semantics/articlehttp://purl.org/coar/resource_type/c_6501Publisher's versioninfo:eu-repo/semantics/publishedVersionhttp://hdl.handle.net/10261/235377reponame:DIGITAL.CSIC. Repositorio Institucional del CSICinstname:Consejo Superior de Investigaciones Científicas (CSIC)Ingléshttp://doi.org/10.1186/s12885-020-6697-7Síinfo:eu-repo/semantics/openAccessoai:digital.csic.es:10261/2353772026-05-22T06:33:51Z
dc.title.none.fl_str_mv 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
spellingShingle Clinical performance evaluation of the Idylla™ EGFR Mutation Test on formalin-fixed paraffin-embedded tissue of non-small cell lung cancer
Delgado-García, Mercedes
Non-small-cell lung carcinoma
EGFR
Mutations
title_short 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_sort Clinical performance evaluation of the Idylla™ EGFR Mutation Test on formalin-fixed paraffin-embedded tissue of non-small cell lung cancer
dc.creator.none.fl_str_mv Delgado-García, Mercedes
Weynand, Birgit
Gómez Izquierdo, Lourdes
Hernández, María José
Blanco, Ángela María
Varela, Mar
Matías-Guiu, Xavier
Nadal, Ernest
Márquez-Lobo, Bélgica
Alarcão, Ana
Álava, Enrique de
Biscuola, Michele
author Delgado-García, Mercedes
author_facet Delgado-García, Mercedes
Weynand, Birgit
Gómez Izquierdo, Lourdes
Hernández, María José
Blanco, Ángela María
Varela, Mar
Matías-Guiu, Xavier
Nadal, Ernest
Márquez-Lobo, Bélgica
Alarcão, Ana
Álava, Enrique de
Biscuola, Michele
author_role author
author2 Weynand, Birgit
Gómez Izquierdo, Lourdes
Hernández, María José
Blanco, Ángela María
Varela, Mar
Matías-Guiu, Xavier
Nadal, Ernest
Márquez-Lobo, Bélgica
Alarcão, Ana
Álava, Enrique de
Biscuola, Michele
author2_role author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Consejo Superior de Investigaciones Científicas [https://ror.org/02gfc7t72]
dc.subject.none.fl_str_mv Non-small-cell lung carcinoma
EGFR
Mutations
topic Non-small-cell lung carcinoma
EGFR
Mutations
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.
publishDate 2020
dc.date.none.fl_str_mv 2020
2021
2021
2021
dc.type.none.fl_str_mv info:eu-repo/semantics/article
http://purl.org/coar/resource_type/c_6501
Publisher's version
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/10261/235377
url http://hdl.handle.net/10261/235377
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv http://doi.org/10.1186/s12885-020-6697-7
Sí
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv BioMed Central
publisher.none.fl_str_mv BioMed Central
dc.source.none.fl_str_mv reponame:DIGITAL.CSIC. Repositorio Institucional del CSIC
instname:Consejo Superior de Investigaciones Científicas (CSIC)
instname_str Consejo Superior de Investigaciones Científicas (CSIC)
reponame_str DIGITAL.CSIC. Repositorio Institucional del CSIC
collection DIGITAL.CSIC. Repositorio Institucional del CSIC
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_ 1869403600366600192
score 15,198674

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