Article
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.
PloS one - 1 Jan 2013
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
Abstract excerpt
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. METHODS: Melanoma specimens were tested for BRAF V600 mutations at two laboratories with the: cobas BRAF Mutation...
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