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.

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.

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.Melanoma sp...

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Bibliographic Details
Main Authors: Fernando Lopez-Rios, Barbara Angulo, Belen Gomez, Debbie Mair, Rebeca Martinez, Esther Conde, Felice Shieh, Jeffrey Vaks, Rachel Langland, H Jeffrey Lawrence, David Gonzalez de Castro
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2013-01-01
Series:PLoS ONE
Online Access:http://europepmc.org/articles/PMC3542342?pdf=render

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http://europepmc.org/articles/PMC3542342?pdf=render

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