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

BMC Cancer ◽  
2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Mercedes Delgado-García ◽  
Birgit Weynand ◽  
Lourdes Gómez-Izquierdo ◽  
María José Hernández ◽  
Ángela María Blanco ◽  
...  
2021 ◽  
pp. 101745
Author(s):  
Tamyres Mingorance Carvalho ◽  
Renata Montoro Dourado ◽  
Sueli Massumi Nakatani ◽  
Cesar Augusto Barros Duarte ◽  
Sergio Ossamu Ioshii ◽  
...  

Author(s):  
Mercedes Delgado-Garcia ◽  
Birgit Weynand ◽  
Lourdes Gómez Izquierdo ◽  
María José Hernández Barrera ◽  
Ángela María Blanco Lobo ◽  
...  

Abstract BackgroundDetection 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 tyrosine kinase inhibitors in EGFR -mutated patients. Therefore, choosing a suitable technique for testing 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 sample. The aim of this study was the evaluation of the Idylla™ EGFR Mutation Test on the Idylla™ System conducting a Clinical Performance Evaluation.MethodsEGFR 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)ResultsThe 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%.ConclusionsThe Idylla™ EGFR Mutation Test passed its clinical validity performance characteristics for accuracy.


2018 ◽  
Vol 142 (4) ◽  
pp. 480-489 ◽  
Author(s):  
Greta Alì ◽  
Rossella Bruno ◽  
Mauro Savino ◽  
Riccardo Giannini ◽  
Serena Pelliccioni ◽  
...  

Context.— Patients with non–small cell lung cancer harboring ALK receptor tyrosine kinase (ALK), ROS proto-oncogene 1 (ROS1), and ret proto-oncogene (RET) gene rearrangements can benefit from specific kinase inhibitors. Detection of fusion genes is critical for determining the best treatment. Assessing rearrangements in non–small cell lung cancer remains challenging, particularly for lung cytology. Objective.— To examine the possible application of the multiplex, transcript-based NanoString system (NanoString Technologies, Seattle, Washington) in the evaluation of fusion genes in lung adenocarcinoma samples. Data Sources.— This study is a narrative literature review. Studies about NanoString, gene fusions, and lung adenocarcinoma were collected from PubMed (National Center for Biotechnology Information, Bethesda, Maryland). We found 7 articles about the application of the NanoString system to detect fusion genes on formalin-fixed, paraffin-embedded tumor tissues and one article evaluating the adequacy of lung cytologic specimens for NanoString gene expression analysis. Conclusions.— To maximize the yield of molecular tests on small lung biopsies, the NanoString nCounter system has been suggested to detect fusion genes. NanoString fusion gene assays have been successfully applied on formalin-fixed, paraffin-embedded tissues. Although there are only a few studies available, the application of NanoString assays may also be feasible in lung cytology. According to available data, the NanoString system could strengthen the routine molecular characterization of lung adenocarcinoma.


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