gb ONCO BRAF (V600E)
quantitative real-time PCR
This in vitro diagnostic kit is used to detect and quantify the BRAF V600E, E2, D and D2 somatic mutations in human genomic DNA. The detection principle is based on real-time polymerase chain reaction (qPCR) using fluorescently labelled probes and allele specific primers.
Clinical implications of the CE IVD kit
Single nucleotide mutation of the BRAF V600E gene leads to increased activation of the MAP kinase cascade, resulting in proliferation and dedifferentiation. However, the BRAF gene mutation alone is not sufficient to induce a malignant transformation, its role lies more in the progression of the disease than in the initiation.
The occurrence of the BRAF V600E mutation was observed, for example, in melanoma, Langerhans’ ischemia of the pancreas, or ovarian and colon cancers. BRAF gene mutations are also associated with a number of tumors (malignant melanoma, non-Hodgkin’s lymphoma, thyroid papillary carcinoma, non-small cell lung carcinoma and lung adenocarcinoma). Prior to initiating treatment with vemurafenib or dabrafenib, patients should be confirmed with the validated test of the V600 mutation of the BRAF gene. Vemurafenib is not suitable for patients with malignant melanoma and a wild type variant of the BRAF gene.
Parameters of the real-time PCR diagnostic kit
- ready-to-use assay
- LOD 0.05% mutated BRAF on WT background at 100,000 copies in reaction
- sample concentration 4-80 ng/µl
- positive and negative controls included
- FAM channel detection
- identical amplification profile as gb HEMO, gb GENETIC, gb PHARM kits