{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,17]],"date-time":"2026-10-17T07:47:49Z","timestamp":1792223269099,"version":"4.4.0"},"reference-count":29,"publisher":"MDPI AG","issue":"1","license":[{"start":{"date-parts":[[2022,12,31]],"date-time":"2022-12-31T00:00:00Z","timestamp":1672444800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancers"],"abstract":"<jats:p>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.<\/jats:p>","DOI":"10.3390\/cancers15010292","type":"journal-article","created":{"date-parts":[[2023,1,2]],"date-time":"2023-01-02T03:00:59Z","timestamp":1672628459000},"page":"292","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["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"],"prefix":"10.3390","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3815-9052","authenticated-orcid":false,"given":"Alvaro","family":"Leone","sequence":"first","affiliation":[{"name":"Anatomic Pathology Unit, San Camillo-Forlanini Hospitals, 00152 Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1866-8151","authenticated-orcid":false,"given":"Lucia Anna","family":"Muscarella","sequence":"additional","affiliation":[{"name":"Laboratory of Oncology, Fondazione IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, 71013 Foggia, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7066-7896","authenticated-orcid":false,"given":"Paolo","family":"Graziano","sequence":"additional","affiliation":[{"name":"Unit of Pathology, Fondazione IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, 71013 Foggia, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Tornese","sequence":"additional","affiliation":[{"name":"Anatomic Pathology Unit, San Camillo-Forlanini Hospitals, 00152 Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lucia Rosalba","family":"Grillo","sequence":"additional","affiliation":[{"name":"Anatomic Pathology Unit, San Camillo-Forlanini Hospitals, 00152 Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angela","family":"Di Lorenzo","sequence":"additional","affiliation":[{"name":"Anatomic Pathology Unit, San Camillo-Forlanini Hospitals, 00152 Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monica","family":"Bronzini","sequence":"additional","affiliation":[{"name":"Anatomic Pathology Unit, San Camillo-Forlanini Hospitals, 00152 Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefania","family":"Scarpino","sequence":"additional","affiliation":[{"name":"Department of Clinical and Molecular Medicine, Pathology Unit, St. Andrea University Hospital, University of Rome La Sapienza, 00187 Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angelo","family":"Sparaneo","sequence":"additional","affiliation":[{"name":"Laboratory of Oncology, Fondazione IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, 71013 Foggia, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8855-1218","authenticated-orcid":false,"given":"Giulio","family":"Rossi","sequence":"additional","affiliation":[{"name":"Operative Unit of Pathologic Anatomy, Department of Oncology, Fondazione Poliambulanza Hospital Institute, 25124 Brescia, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2022,12,31]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"1998","DOI":"10.1001\/jama.2014.3741","article-title":"Using multiplexed assays of oncogenic drivers in lung cancers to select targeted drugs","volume":"311","author":"Kris","year":"2014","journal-title":"JAMA"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"468","DOI":"10.1038\/modpathol.2014.107","article-title":"Comprehensive analysis of RET and ROS1 rearrangement in lung adenocarcinoma","volume":"28","author":"Lee","year":"2015","journal-title":"Mod. 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