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Multi-center evaluation of the novel fully-automated PCR-based Idylla™ BRAF Mutation Test on formalin-fixed paraffin-embedded tissue of malignant melanoma.

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dc.contributor.author Melchior, Linea
dc.contributor.author Grauslund, Morten
dc.contributor.author Bellosillo Paricio, Beatriz
dc.contributor.author Montagut Viladot, Clara
dc.contributor.author Torres, Erica
dc.contributor.author Moragón, Ester
dc.contributor.author Micalessi, Isabel
dc.contributor.author Frans, Johan
dc.contributor.author Noten, Veerle
dc.contributor.author Bourgain, Claire
dc.contributor.author Vriesema, Renske
dc.contributor.author van der Geize, Robert
dc.contributor.author Cokelaere, Kristof
dc.contributor.author Vercooren, Nancy
dc.contributor.author Crul, Katrien
dc.contributor.author Rüdiger, Thomas
dc.contributor.author Buchmüller, Diana
dc.contributor.author Reijans, Martin
dc.contributor.author Jans, Caroline
dc.date.accessioned 2016-02-23T11:07:49Z
dc.date.available 2016-12-31T03:00:04Z
dc.date.issued 2015
dc.identifier.citation Melchior L, Grauslund M, Bellosillo B, Montagut C, Torres E, Moragón E. et al. Multi-center evaluation of the novel fully-automated PCR-based Idylla™ BRAF Mutation Test on formalin-fixed paraffin-embedded tissue of malignant melanoma. Exp Mol Pathol. 2015 Dec;99(3):485-91. doi: 10.1016/j.yexmp.2015.09.004.
dc.identifier.issn 0014-4800
dc.identifier.uri http://hdl.handle.net/10230/25924
dc.description.abstract The advent of BRAF-targeted therapies led to increased survival in patients with metastatic melanomas harboring a BRAF V600 mutation (implicated in 46–48% of malignant melanomas). The Idylla™ System (Idylla™), i.e., the real-time-PCR-based Idylla™ BRAF Mutation Test performed on the fully-automated Idylla™ platform, enables detection of the most frequent BRAF V600 mutations (V600E/E2/D, V600K/R/M) in tumor material within approximately 90 min and with 1% detection limit. Idylla™ performance was determined in a multi-center study by analyzing BRAF mutational status of 148 archival formalin-fixed paraffin-embedded (FFPE) tumor samples from malignant melanoma patients, and comparing Idylla™ results with assessments made by commercial or in-house routine diagnostic methods. Of the 148 samples analyzed, Idylla™ initially recorded 7 insufficient DNA input calls and 15 results discordant with routine method results. Further analysis learned that the quality of 8 samples was insufficient for Idylla™ testing, 1 sample had an invalid routine test result, and Idylla™ results were confirmed in 10 samples. Hence, Idylla™ identified all mutations present, including 7 not identified by routine methods. Idylla™ enables fully automated BRAF V600 testing directly on FFPE tumor tissue with increased sensitivity, ease-of-use, and much shorter turnaround time compared to existing diagnostic tests, making it a tool for rapid, simple and highly reliable analysis of therapeutically relevant BRAF mutations, in particular for diagnostic units without molecular expertise and infrastructure.
dc.format.mimetype application/pdf
dc.language.iso eng
dc.publisher Elsevier
dc.relation.ispartof Experimental and Molecular Pathology. 2015 Dec;99(3):485-91
dc.rights © 2015 Elsevier Inc. All rights reserved. Melchior L, Grauslund M, Bellosillo B, Montagut C, Torres E, Moragón E. et al. Multi-center evaluation of the novel fully-automated PCR-based Idylla™ BRAF Mutation Test on formalin-fixed paraffin-embedded tissue of malignant melanoma. Exp Mol Pathol. 2015 Dec;99(3):485-91.
dc.subject.other Melanoma
dc.title Multi-center evaluation of the novel fully-automated PCR-based Idylla™ BRAF Mutation Test on formalin-fixed paraffin-embedded tissue of malignant melanoma.
dc.type info:eu-repo/semantics/article
dc.identifier.doi http://dx.doi.org/10.1016/j.yexmp.2015.09.004
dc.rights.accessRights info:eu-repo/semantics/openAccess
dc.type.version info:eu-repo/semantics/acceptedVersion

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