Solid Tumors

The cobas 4800 BRAF V600 Mutation Test is a real-time PCR assay intended for the qualitative detection of the BRAF V600E mutation in DNA extracted from formalin fixed, paraffin-embedded human tumor tissue.

disease state indication(s)
Colorectal Cancer (CRC), Non-Small Cell Lung Cancer (NSCLC), Thyroid Cancer, Hairy Cell Leukemia

clinical use
Diagnostic, Predictive, Prognostic
BRAF is part of the MAP kinase pathway, and oncogenic mutations in BRAF, the majority of which are the V600E mutation, lead to constitutive activation of downstream signaling. BRAF mutations have been reported in a wide range of human cancers, including but not limited to all classic forms of hairy cell leukemia, approximately half of melanomas, thyroid cancers, Langerhans cell histiocytosis, colorectal cancers, non-small cell lung cancers, and ovarian cancers. BRAF V600E mutation analysis can be helpful in predicting the likelihood of response to BRAF inhibitors in melanomas and non-small cell lung cancers, and in assessing the prognosis and likelihood of response to EGFR inhibitors in colorectal cancers. BRAF mutation analysis may also be useful in differentiating between hairy cell leukemia and its mimics, and in predicting the risk of malignancy in thyroid FNA samples with indeterminate cytology.

methodology/product platform
Polymerase chain reaction (PCR)

specimen type and requirements
Preferred: One (1) or two (2) formalin-fixed, paraffin-embedded (FFPE) blocks containing tumor tissue from most recent surgery or biopsy.
Acceptable Alternative: One (1) unstained formalin-fixed, paraffin-embedded (FFPE) tissue section cut at 2×5 µm thickness, plus accompanying H&E slide.
Unacceptable: Specimens preserved in alternative (non-formalin) fixatives, decalcified specimens, fresh or frozen tissue.
Note: Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen.

turnaround time
Global (TC & PC): 7 days

cpt code(s)
81210 (x1)

medicare moldx cpt code
Not applicable

regulatory classification
Laboratory developed test (LDT)

ordering option
Global (TC & PC)