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: | , , , , , , , , , , , |
|---|---|
| Tipo de recurso: | artículo |
| Estado: | Versión publicada |
| Fecha de publicación: | 2020 |
| País: | España |
| Institución: | Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya) |
| Repositorio: | Recercat. Dipósit de la Recerca de Catalunya |
| OAI Identifier: | oai:recercat.cat:10459.1/70715 |
| Acceso en línea: | https://doi.org/10.1186/s12885-020-6697-7 http://hdl.handle.net/10459.1/70715 |
| Access Level: | acceso abierto |
| Palabra clave: | Non-small-cell lung carcinoma EGFR Mutations |
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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, MarMatias-Guiu, XavierNadal, ErnestMárquez-Lobo, BélgicaAlarcão, Anade Álava, EnriqueBiscuola, MicheleNon-small-cell lung carcinomaEGFRMutationsBackground: 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 accuracySupported by each clinical center. Biocartis provided free-of-charge Idylla™ EGFR Mutation Test cartridgesBMC2020info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://doi.org/10.1186/s12885-020-6697-7http://hdl.handle.net/10459.1/70715reponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésReproducció del document publicat a https://doi.org/10.1186/s12885-020-6697-7BMC Cancer, 2020, vol. 20cc-by (c) Delgado-García et al., 2020info:eu-repo/semantics/openAccesshttp://creativecommons.org/licenses/by/4.0/oai:recercat.cat:10459.1/707152026-05-29T05:05:01Z |
| 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 Matias-Guiu, Xavier Nadal, Ernest Márquez-Lobo, Bélgica Alarcão, Ana de Álava, Enrique Biscuola, Michele |
| author |
Delgado-García, Mercedes |
| 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_role |
author |
| author2 |
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 |
| author2_role |
author author author author author author author author author author author |
| 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. 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 |
| publishDate |
2020 |
| dc.date.none.fl_str_mv |
2020 |
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info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion |
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article |
| status_str |
publishedVersion |
| dc.identifier.none.fl_str_mv |
https://doi.org/10.1186/s12885-020-6697-7 http://hdl.handle.net/10459.1/70715 |
| url |
https://doi.org/10.1186/s12885-020-6697-7 http://hdl.handle.net/10459.1/70715 |
| dc.language.none.fl_str_mv |
Inglés |
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Inglés |
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Reproducció del document publicat a https://doi.org/10.1186/s12885-020-6697-7 BMC Cancer, 2020, vol. 20 |
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cc-by (c) Delgado-García et al., 2020 info:eu-repo/semantics/openAccess http://creativecommons.org/licenses/by/4.0/ |
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cc-by (c) Delgado-García et al., 2020 http://creativecommons.org/licenses/by/4.0/ |
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openAccess |
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BMC |
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BMC |
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reponame:Recercat. Dipósit de la Recerca de Catalunya instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya) |
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Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya) |
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Recercat. Dipósit de la Recerca de Catalunya |
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Recercat. Dipósit de la Recerca de Catalunya |
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