Clinical performance evaluation of the Idylla™ EGFR Mutation Test on formalin-fixed paraffin-embedded tissue of non-small cell lung cance

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2020
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
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Delgado-García, Mercedes; Weynand, Birgit; Gómez-Izquierdo, Lourdes; Hernández, María José; Blanco, Ángela María; Varela, Mar; ... Biscuola, Michele. (2020) . Clinical performance evaluation of the Idylla™ EGFR Mutation Test on formalin-fixed paraffin-embedded tissue of non-small cell lung cance. BMC Cancer, 2020, vol. 20. https://doi.org/10.1186/s12885-020-6697-7.
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Abstract
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
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http://hdl.handle.net/10459.1/70715
DOI
https://doi.org/10.1186/s12885-020-6697-7
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BMC Cancer, 2020, vol. 20
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cc-by (c) Delgado-García et al., 2020
Except where otherwise noted, this item's license is described as cc-by (c) Delgado-García et al., 2020