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Comparison of Testing Methods for the Detection of BRAF V600E Mutations in Malignant Melanoma: Pre-Approval Validation Study of the Companion Diagnostic Test for Vemurafenib

BACKGROUND: The cobas 4800 BRAF V600 Mutation Test is a CE-marked and FDA-approved in vitro diagnostic assay used to select patients with metastatic melanoma for treatment with the selective BRAF inhibitor vemurafenib. We describe the pre-approval validation of this test in two external laboratories...

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Detalles Bibliográficos
Autores principales: Lopez-Rios, Fernando, Angulo, Barbara, Gomez, Belen, Mair, Debbie, Martinez, Rebeca, Conde, Esther, Shieh, Felice, Vaks, Jeffrey, Langland, Rachel, Lawrence, H. Jeffrey, de Castro, David Gonzalez
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3542342/
https://www.ncbi.nlm.nih.gov/pubmed/23326492
http://dx.doi.org/10.1371/journal.pone.0053733