{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,13]],"date-time":"2026-03-13T18:46:16Z","timestamp":1773427576798,"version":"3.50.1"},"reference-count":10,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2024,5,25]],"date-time":"2024-05-25T00:00:00Z","timestamp":1716595200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,5,25]],"date-time":"2024-05-25T00:00:00Z","timestamp":1716595200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Diagn Pathol"],"abstract":"<jats:title>Abstract<\/jats:title><jats:p><jats:italic>IDH1<\/jats:italic> and <jats:italic>IDH2<\/jats:italic> mutational status is a critical biomarker with diagnostic, prognostic, and treatment implications in glioma. Although <jats:italic>IDH1<\/jats:italic> p.R132H-specific immunohistochemistry is available, it is unable to identify other mutations in <jats:italic>IDH1\/2<\/jats:italic>. Next-generation sequencing can accurately determine <jats:italic>IDH1\/2<\/jats:italic> mutational status but suffers from long turnaround time when urgent treatment planning and initiation is medically necessary. The Idylla assay can detect <jats:italic>IDH1\/2<\/jats:italic> mutational status from unstained formalin-fixed paraffin-embedded (FFPE) slides in as little as a few hours. In a clinical validation, we demonstrate clinical accuracy of 97% compared to next-generation sequencing. Sensitivity studies demonstrated a limit of detection of 2.5-5% variant allele frequency, even at DNA inputs below the manufacturer\u2019s recommended threshold. Overall, the assay is an effective and accurate method for rapid determination of <jats:italic>IDH1\/2<\/jats:italic> mutational status.<\/jats:p>","DOI":"10.1186\/s13000-024-01492-3","type":"journal-article","created":{"date-parts":[[2024,5,25]],"date-time":"2024-05-25T17:01:43Z","timestamp":1716656503000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Evaluation of the rapid Idylla IDH1-2 mutation assay in FFPE glioma samples"],"prefix":"10.1186","volume":"19","author":[{"given":"James P.","family":"Solomon","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carlos","family":"Munoz-Zuluaga","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cheyanne","family":"Slocum","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alicia","family":"Dillard","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lin","family":"Cong","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jiajing","family":"Wang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Neal","family":"Lindeman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael","family":"Kluk","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Benjamin","family":"Liechty","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Pisapia","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hanna","family":"Rennert","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Priya D.","family":"Velu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2024,5,25]]},"reference":[{"issue":"15","key":"1492_CR1","doi-asserted-by":"publisher","first-page":"1949","DOI":"10.1038\/s41388-017-0077-z","volume":"37","author":"RJ Molenaar","year":"2018","unstructured":"Molenaar RJ, et al. Wild-type and mutated IDH1\/2 enzymes and therapy responses. Oncogene. 2018;37(15):1949\u201360.","journal-title":"Oncogene"},{"issue":"11","key":"1492_CR2","doi-asserted-by":"publisher","first-page":"1580","DOI":"10.1038\/s41416-020-0814-x","volume":"122","author":"S Han","year":"2020","unstructured":"Han S, et al. IDH mutation in glioma: molecular mechanisms and potential therapeutic targets. Br J Cancer. 2020;122(11):1580\u20139.","journal-title":"Br J Cancer"},{"key":"1492_CR3","doi-asserted-by":"crossref","unstructured":"Kaminska B et al. Consequences of IDH1\/2 mutations in Gliomas and an Assessment of inhibitors targeting mutated IDH proteins. Molecules, 2019. 24(5).","DOI":"10.3390\/molecules24050968"},{"issue":"8","key":"1492_CR4","doi-asserted-by":"publisher","first-page":"765","DOI":"10.1056\/NEJMoa0808710","volume":"360","author":"H Yan","year":"2009","unstructured":"Yan H, et al. IDH1 and IDH2 mutations in gliomas. 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The authors did not receive support from any organization for the submitted work.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}],"article-number":"70"}}