BRAF Gene Mutation Analysis

Also known as: Oncomine Dx Target Test

Clinical Use

Use

BRAF is an important member of the mitogen-activated protein kinase (MAPK) pathway that influences cell proliferation. This test will detect all V600 mutations of the BRAF oncogene frequently found in human cancers, such as melanoma, colorectal cancer, lung cancer, ovarian cancer, thyroid cancer, and hairy cell leukemia, allowing the determination of drug response, aiding the diagnosis and providing prognosis information. More than 90% of mutations are the V600E (c1799T>A) mutation, but other V600 mutations have been reported.

Special Instructions

Not provided.

Limitations

This assay can detect 5% mutation amid a backdrop of wild-type DNA. The test is not FDA-cleared or approved, as both its development and performance characteristics were established by Labcorp.

Test Details

Methodology

PCR-based (PCR)

Biomarkers

BRAF

Gene

V600 Mutation Detection

Mutation • Categorical (e.g., Positive / Negative / Indeterminate)

Result Turnaround Time

5-7 days

Specimen

Tumor Tissue (FFPE)

Volume

FFPE tissue block or four unstained slides and one matching H&E-stained slide at 5 μM; 5 to 10 mL FNA in CytoLyt container

Minimum Volume

Two unstained slides and one matching H&E-stained slide at 5 μM; 5 mL FNA

Container

FFPE tissue block or slides

Storage Instructions

Maintain specimen at room temperature. If specimen is to be stored prior to shipment, store at 2°C to 8°C. Store FFPE block or slides, FNA in CytoLyt container at room temperature.