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BRAF Gene Mutation Analysis - Melanoma

CPT 81210; 88381

Test Details

Cancer Type

Melanoma

Technology Used

Molecular

Turnaround Time

7 - 10 days

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Use

The THxID™-BRAF kit is an In Vitro Diagnostic device intended for the qualitative detection of the BRAFV600E and V600K mutations in DNA samples extracted from formalin-fixed paraffin-embedded (FFPE) human melanomatissue. The THxID™-BRAF kit is a real-time PCR test on the ABI 7500 Fast Dx system and is intended to be used as an aid in selecting melanoma patients whose tumors carry the BRAF V600E mutation for treatment with dabrafenib (Tafinlar®) and as an aid in selecting melanoma patients whose tumors carry the BRAF V600E or V600K mutation for treatment with trametinib (Mekinist™).

Special Instructions

Please provide a copy of the pathology report. Direct any questions regarding this test to customer service at 800-345-4363. BRAF testing will be delayed if the pathology report is not received.

Limitations

This assay is able to detect 5% mutation in a background of wild-type DNA.

Methodology

Amplification refraction mutation-specific system (ARMS) polymerase chain reaction (PCR)

Specimen Requirements

Information on collection, storage, and volume

Specimen

Formalin-fixed, paraffin-embedded (FFPE) tissue block or slides

Volume

Formalin-fixed, paraffin-embedded tissue block or eight unstained slides and one matching H&E-stained slide at 5 μM.

Minimum Volume

Four unstained slides at 5 μM and one matching H&E-stained slide. The minimum total tumor surface area needed for this assay is 40 mm² for 5-μm sections and >80% tumor cells.

Container

Formalin-fixed, paraffin-embedded (FFPE) tissue blocks or slides

Storage Instructions

Ship at room temperature. Store FFPE block or slides at room temperature.

Causes for Rejection

Tumor block containing insufficient tumor tissue; tumor is not melanoma primary; broken or stained slides

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