Clinical performance evaluation of the Idylla™ EGFR Mutation Test on formalin-fixed paraffin-embedded tissue of non-small cell lung cance
Hernández, María José
Blanco, Ángela María
de Álava, Enrique
MetadataShow full item record
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
Is part ofBMC Cancer, 2020, vol. 20
European research projects
The following license files are associated with this item:
Except where otherwise noted, this item's license is described as cc-by (c) Delgado-García et al., 2020
Showing items related by title, author, creator and subject.
Concordance study between one-step nucleic acid amplification and morphologic techniques to detect lymph node metastasis in papillary carcinoma of the thyroid del Carmen, Sofía; Gatius Calderó, Sònia; Franch Arcas, Guzmán; Baena-Fustegueras, Juan A; Gonzalez, Oscar; Zafon, Carles; Cuevas, Dolors; Valls Marsal, Joan; Pérez, Angustias; Martinez, Mercedes; Ros López, Susana; García Macías, Carmen; Iglesias, Carmela; Matias-Guiu, Xavier; de Álava, Enrique (Elsevier, 2016)Tumor resection in papillary thyroid carcinoma (PTC) is often accompanied by lymph node (LN) removal of the central and lateral cervical compartments. One-step nucleic acid amplification (OSNA) is a polymerase chain ...
Multilayer OMIC data in medullary thyroid carcinoma identifies the STAT3 pathway as a potential therapeutic target in RETM918T tumors Mancikova, Veronica; Montero Conde, Cristina; Perales Paton, Javier; Fernandez, Agustin F; Santacana Espasa, Maria; Jodkowska, Karolina; Inglada-Pérez, Lucía; Castelblanco Echavarría, Esmeralda; Borrego, Salud; Encinas Martín, Mario; Matias-Guiu, Xavier; Fraga, Mario; Robledo, Mercedes (American Association for Cancer Research., 2016-09-12)Purpose: Medullary thyroid carcinoma (MTC) is a rare disease with few genetic drivers, and the etiology specific to each known susceptibility mutation remains unknown. Exploiting multilayer genomic data, we focused our ...
Absence of Nuclear p16 Is a Diagnostic and Independent Prognostic Biomarker in Squamous Cell Carcinoma of the Cervix Mendaza, Saioa; Fernández-Irigoyen, Joaquín; Santamaría, Enrique; Zudaire, Tamara; Guarch, Rosa; Guerrero-Setas, David; Vidal, August; Santos-Salas, José; Matias-Guiu, Xavier; Ausín, Karina; Díaz de Cerio, María José; Martín-Sánchez, Esperanza (MDPI, 2020)The tumor-suppressor protein p16 is paradoxically overexpressed in cervical cancer (CC). Despite its potential as a biomarker, its clinical value and the reasons for its failure in tumor suppression remain unclear. Our ...