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

Melchior, Linea; Grauslund, Morten; Bellosillo Paricio, Beatriz; Montagut Viladot, Clara; Torres, Erica; Moragón, Ester; Micalessi, Isabel; Frans, Johan; Noten, Veerle; Bourgain, Claire; Vriesema, Renske; van der Geize, Robert; Cokelaere, Kristof; Vercooren, Nancy; Crul, Katrien; Rüdiger, Thomas; Buchmüller, Diana; Reijans, Martin; Jans, Caroline

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, Lineaca
dc.contributor.author Grauslund, Mortenca
dc.contributor.author Bellosillo Paricio, Beatrizca
dc.contributor.author Montagut Viladot, Claraca
dc.contributor.author Torres, Ericaca
dc.contributor.author Moragón, Esterca
dc.contributor.author Micalessi, Isabelca
dc.contributor.author Frans, Johanca
dc.contributor.author Noten, Veerleca
dc.contributor.author Bourgain, Claireca
dc.contributor.author Vriesema, Renskeca
dc.contributor.author van der Geize, Robertca
dc.contributor.author Cokelaere, Kristofca
dc.contributor.author Vercooren, Nancyca
dc.contributor.author Crul, Katrienca
dc.contributor.author Rüdiger, Thomasca
dc.contributor.author Buchmüller, Dianaca
dc.contributor.author Reijans, Martinca
dc.contributor.author Jans, Carolineca
dc.date.accessioned 2016-02-23T11:07:49Z
dc.date.available 2016-12-31T03:00:04Z
dc.date.issued 2015
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.ca
dc.format.mimetype application/pdfca
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.ca
dc.identifier.doi http://dx.doi.org/10.1016/j.yexmp.2015.09.004
dc.identifier.issn 0014-4800
dc.identifier.uri http://hdl.handle.net/10230/25924
dc.language.iso engca
dc.publisher Elsevierca
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.ca
dc.rights.accessRights info:eu-repo/semantics/openAccess
dc.subject.other Melanomaca
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.ca
dc.type info:eu-repo/semantics/articleca
dc.type.version info:eu-repo/semantics/acceptedVersionca

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