Test Directory

BRAF Mutation Analysis

Synonym(s):

BRAF, B-RAF, RAF

Application:

BRAF is part of the mitogen-activated protein kinase (MAPK) pathway which regulates cell growth, proliferation, and differentiation. BRAF mutations are found in several cancers, including melanoma, non-small cell lung cancer, colorectal cancer, thyroid cancer, and hairy-cell leukemia. BRAF gene mutation testing can aid in the diagnosis, prognosis, and predicting patient outcome in response to targeted therapies.

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

Department:

Molecular Pathology

Method:

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.

Turnaround:

15 business days from receipt

Performed:

Wednesday

Retention:

Extracted DNA is kept for a minimum of 60 days

CPT Code:*

81210

Test Code(s):

BRAFPCR

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

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