cobas® 4800 BRAF V600 Mutation Test - Acquired genetic alteration IVDs

Intended purpose

IVDs that are intended to be used in genetic testing to provide information about acquired genetic alterations, which may include chromosomal alterations, mutations and/or alterations in gene expression, and which may be used to characterise haematological or solid tumour malignancies and/or provide prognostic information.

Functional description

The primary use of the cobas® 4800 BRAF V600 Mutation Test is the detection of the BRAF V600 mutations in DNA extracted from formalin-fixed, paraffin-embedded human melanoma and papillary thyroid carcinoma (PTC) tissue. In melanoma, it is intended to be used as an aid in selecting patients whose tumors carry BRAF V600 mutations for treatment either with ZELBORAF® (vemurafenib) alone, or with COTELLIC® (cobimetinib) in combination with ZELBORAF® (vemurafenib).