ctDNA BRAF V600 Mutation Detection Kit

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ctDNA BRAF V600 Mutation Detection Kit

*Includes all controls.


Cell-free Mutation Detection

Over 50% of metastatic melanomas harbor a BRAF activating mutation in codon 600. Testing for these mutations in tumor tissue is routinely done to guide therapy. Recent studies have demonstrated the utility of detecting BRAF mutations in cell-free DNA isolated from plasma of patients diagnosed with melanoma to supplement or replace testing in tissue. Furthermore, mutations in cell-free DNA have been shown to correlate with disease progression when used to monitor treatment response over the course of therapy.

EntroGen has developed a non-invasive, ultra-sensitive real-time PCR test for detection of BRAF V600 mutations in cell-free DNA isolated from plasma. Analytical performance studies have shown that the test can detect single digit copy numbers of the BRAF variant and requires low amount of DNA (2ng) per sample. The test detects BRAF V600E, V600E2, V600K and V600D mutations.




Testing Procedure

EntroGen’s ctBRAF Mutation Detection Kit is a real-time polymerase chain reaction (PCR)-based assay that uses mutant-specific primers to identify the presence of BRAF V600 mutations. The testing procedure involves three (3) simple steps, which can be completed in approximately 2 hours from DNA isolated from plasma to test results:

  • PCR setup with reagents included in the kit
  • Amplification and detection using a real-time PCR instrument
  • Data analysis


Equipment and Materials

The ctBRAF Mutation Detection Kit requires a real-time PCR instrument capable of detecting FAM and VIC fluorescent probes simultaneously.

This test includes reagents required for the PCR amplification/detection, as well as validated reaction controls. Columns and reagents for cell-free DNA isolation are not included.


Intended Use

USA: Available for research use only (RUO). Not for use in diagnostic procedures.

Europe: Available for research (RUO) and diagnostic (CE-IVD) purposes.

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