Test Directory

BRAF Mutation Analysis, Melanoma




The FDA-approved Cobas® BRAF V600 Mutation Test is a real-time PCR assay designed for the qualitative detection of the V600E (T1799A) mutation in melanoma tissue. The test is indicated as a companion diagnostic to aid in selecting melanoma patients for treatment with vemurafenib therapy.

Specimen Type:

Formalin-fixed, paraffin-embedded (FFPE) tissue block or 3 unstained slides at 5µM and one matching H&E slide.

Required Information:

 Complete the Incyte Diagnostics requisition with the patient's demographics, ordering physician, and a copy of the pathology report.

Specimen Stability:

Blocks and slides should be stored and shipped at room temperature

Unacceptable Specimen:

Tumor tissue with less than 10% neoplastic cells present or broken slides


Molecular Pathology


A board certified Pathologist reviews the H&E slide for neoplastic cell content and identify areas for macrodissection. Performing the test is based on two processes: (1) manual specimen preparation to obtain genomic DNA from FFPE tissue using the Cobas® DNA Sample Preparation Kit for FFPE specimens and (2) PCR amplification and detection of target DNA using a complementary primer pair and two oligonucleotide probes labeled with different fluorescent dyes on the Cobas® z480 analyzer. One probe is designed to detect the wild-type BRAF V600 sequence and one is designed to detect the V600E mutation sequence. Some non-V600E mutations (V600K, V600D, and V600E2), may be detected by the assay. Analytical sensitivity is 5% mutant allele in a background of wild-type allele.


35 business days from receipt




Extracted DNA is kept for a minimum of 60 days.

CPT Code:*


Test Code(s):


*The listed CPT codes are for reference use only. Final coding is based on CPT guidelines and individual circumstances.


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