Multicenter Evaluation of the Idylla GeneFusion in Non–Small-Cell Lung Cancer

Depoilly, Thomas; Garinet, Simon; Kempen, Léon C van; Schuuring, Ed; Clavé, Sergi; Bellosillo, Beatríz; Ercolani, Cristiana; Buglioni, Simonetta; Siemanowski, Janna; Merkelbach‐Bruse, Sabine; Tischler, Verena; Demes, Melanie-Christin; Paridaens, Henry; Sibille, Catherine; Montpréville, Vincent de; Rouleau, Etienne; Bartczak, Artur; Pasieka-Lis, Monika; Teo, Ryan Yee Wei; Chuah, Khoon Leong; Barbosa, Marta; Quintana, Carlos; Biscuola, Michele; Delgado-Garcia, Mercedes; Vacirca, Davide; Rappa, Alessandra; Cashmore, Matthew Asa; Smith, Matthew; Jasionowicz, Piotr; Meeney, Adam; Desmeules, Patrice; Terris, Benoı̂t; Lupo, Audrey

doi:10.1016/j.jmoldx.2022.05.004

Cited by 14 publications

(17 citation statements)

References 34 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…This allows the avoidance of manipulations that can be deleterious for nucleic acid integrity. A prototype of the Idylla GeneFusion assay has been recently evaluated in a multicenter study, showing a concordance with reference methods of 89% [22]. Three papers have been published using the definitive, commercially available Idylla RUO assay.…”

Section: Discussionmentioning

confidence: 95%

Robust Performance of the Novel Research-Use-Only Idylla GeneFusion Assay Using a Diverse Set of Pathological Samples with a Proposed 1-Day Workflow for Advanced NSCLC Evaluation

Leone

Muscarella

Graziano

et al. 2022

Cancers

View full text Add to dashboard Cite

A range of different techniques are available for predictive biomarker testing for non-small-cell lung cancer (NSCLC) clinical management. International guidelines suggest next-generation sequencing (NGS) as the preferred procedure, but other reverse transcriptase-polymerase chain reaction (RT-PCR)-based methods are rapidly evolving. In this study, we evaluated the reliability and accuracy of the IdyllaTM GeneFusion assay, a rapid and fully automated platform able to simultaneously detect ALK, ROS1, RET and NTRK1/2/3 and MET ex14 skipping mutations and compared its performance with routine reference methods. The cohort included thirty-seven NSCLCs plus two parotid gland carcinomas, previously characterized for the above alterations through either IHC, FISH, RT-PCR or NGS. In 36 of 39 cases, the Idylla GeneFusion assay and the reference methods were concordant (overall agreement: 92.3%). Tumor sections stored at room temperature for up to 60 days and 17 cases older than 2 years were successfully characterized. Our results suggest that the Idylla GeneFusion assay is a reliable tool to define gene fusion status and may be a valuable stand-alone diagnostic test when time efficiency is needed or NGS is not feasible.

show abstract

Section: Discussionmentioning

confidence: 95%

Robust Performance of the Novel Research-Use-Only Idylla GeneFusion Assay Using a Diverse Set of Pathological Samples with a Proposed 1-Day Workflow for Advanced NSCLC Evaluation

Leone

Muscarella

Graziano

et al. 2022

Cancers

View full text Add to dashboard Cite

show abstract

“…The performance of the Idylla assay was in line with recently published data. 16 , 17 Notably, the assay was designed to detect NTRK fusions using only imbalance and consequently may yield a lower sensitivity compared with the targeted approach used for other genes. 18 The Genexus system reported ALK rearrangements owing to imbalance for several patients with ALK WT.…”

Section: Discussionmentioning

confidence: 99%

Ultrafast Gene Fusion Assessment for Nonsquamous NSCLC

Hofman¹,

Heeke²,

Bontoux³

et al. 2023

JTO Clinical and Research Reports

View full text Add to dashboard Cite

“…Importantly, the assay was developed with a limited number of NTRK2 -rearranged specimens. 13 , 14 , 15 Furthermore, it has been recently reported that baseline tyrosine kinase gene expression differs among cancer types: (1) NTRK3 displayed higher expression in glioblastoma and colorectal cancer compared with other kinase receptors, such as ALK , ROS1 , RET , and NTRK1 ; and (2) NTRK2 had strong difference in baseline expression between adenocarcinoma and squamous cell carcinoma of the lung. 15 These factors could have affected the NTRK2 and NTRK3 EI method-calling algorithm.…”

Section: Discussionmentioning

confidence: 99%

“…The Idylla GeneFusion Assay (Biocartis, Mechelen, Belgium) is a rapid and automated cartridge-based system optimized for formalin-fixed, paraffin-embedded (FFPE) tumor tissue. 13 , 14 RNA extraction, amplification, multiplex quantitative reverse-transcriptase polymerase chain reaction (RT-qPCR), and data analysis are performed within a single cartridge-based workflow. It detects fusions by the following two methods: (1) fusion-specific (FS) detection and (2) expression imbalance (EI) analysis.…”

Section: Methodsmentioning

confidence: 99%

“…Beta testing reports of an ultrarapid gene fusion assay, using mainly prototype cartridges, revealed encouraging accuracy results. 13 , 14 , 15 In the current study, we evaluated the clinical utility of this recently commercially available assay, using the manufactured kits. We tested its performance of accuracy, tissue acceptance profile, and limit of detection for capturing clinically relevant gene fusions involving ALK , ROS1 , RET , NTRK1/2/3 genes, and MET exon 14 skipping alterations.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation