BRAF Gene Mutation Analysis - Melanoma
Also known as: THXID®-BRAF Kit
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 melanoma tissue. It is a real‑time PCR test on the ABI 7500 Fast Dx system and aids in selecting melanoma patients whose tumors carry BRAFV600E for treatment with dabrafenib (Tafinlar®), and those carrying BRAFV600E or V600K for 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
PCR‑based (PCR)
Biomarkers
Result Turnaround Time
7-10 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
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; minimum tumor surface area 40 mm² (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