RT Journal Article
T1 Clinical performance evaluation of the Idylla™ EGFR Mutation Test on formalin-fixed paraffin-embedded tissue of non-small cell lung cancer.
A1 Delgado-Garcia, Mercedes
A1 Weynand, Birgit
A1 Gomez-Izquierdo, Lourdes
A1 Hernandez, Maria Jose
A1 Blanco, Angela Maria
A1 Varela, Mar
A1 Matias-Guiu, Xavier
A1 Nadal, Ernest
A1 Marquez-Lobo, Belgica
A1 Alarcão, Ana
A1 de Alava, Enrique
A1 Biscuola, Michele
K1 EGFR
K1 Mutations
K1 Non-small-cell lung carcinoma
AB 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. 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). 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%. The Idylla™ EGFR Mutation Test passed its clinical validity performance characteristics for accuracy.
PB Srpinger Nature
YR 2020
FD 2020-04-03
LK http://hdl.handle.net/10668/15321
UL http://hdl.handle.net/10668/15321
LA en
NO Delgado-García M, Weynand B, Gómez-Izquierdo L, Hernández MJ, Blanco ÁM, Varela M, et al. Clinical performance evaluation of the Idylla™ EGFR Mutation Test on formalin-fixed paraffin-embedded tissue of non-small cell lung cancer. BMC Cancer. 2020 Apr 3;20(1):275
DS RISalud
RD Apr 7, 2025