Test Directory

BRAF Mutation Analysis

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Test Description
BRAF Mutation Analysis
Synonym(s)

BRAF, B-RAF, RAF

Test ID

BRAFPCR

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.

Stability

Blocks and slides should be stored and shipped at room temperature

Unacceptable Specimen Conditions

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

Department (code)

Molecular Pathology

Methodology

The BRAF V600 Mutation Test is a real-time PCR assay designed for the qualitative detection of the V600E (T1799A) mutation. Performance characteristics have been determined by Incyte Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration (FDA).


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 a DNA Sample Preparation Kit for FFPE specimens and (2) PCR amplification and detection using probes 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.

Estimated TAT

15 business days from receipt

Testing Schedule

Wednesday

Retention

Extracted DNA is kept for a minimum of 60 days

CPT Code(s)

81210