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 |