THXID® BRAF

A Theranostics approach to stratify melanoma patients

THXID® BRAF is an in vitro diagnostics kit for the qualitative detection of the BRAF V600E and V600K mutations in metastatic melanoma patients. This real-time PCR test provides rapid and reliable results that help target patients with BRAF-mutant unresectable or metastatic melanoma that may be suitable for treatment with BRAF or MEK inhibitor.

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THXID® BRAF is an in vitro diagnostics kit for the qualitative detection of the BRAF V600E and V600K mutations in metastatic melanoma patients. This real-time PCR test provides rapid and reliable results that help target patients with BRAF-mutant unresectable or metastatic melanoma that may be suitable for treatment with BRAF or MEK inhibitor.

  • In 2013, bioMérieux launched the THXID® BRAF kit, its first personalized medicine test, developed in collaboration with GSK, and designed to stratify malignant melanoma patients.
  • This approval marks the result of a fruitful collaboration between GSK and bioMérieux. It was initiated in 2010, to develop a companion diagnostic test to detect BRAF V600E and V600K gene mutations found in several cancers, including melanoma. GSK and bioMérieux continue to collaborate on new uses of the THXID®-BRAF assay.

About Melanoma and Metastatic Melanoma

Melanoma is the most serious and deadly form of skin cancer1.

In 2008, the number of melanoma cases worldwide was estimated to 199,000 cases, causing 46 000 deaths2.

When melanoma spreads in the body, the disease is called metastatic melanoma. Metastatic melanoma is the most severe form of skin cancer, with an average survival of only 8 months following diagnosis and overall 5-year survival of less than 10%3.

The MAP kinase pathway

BRAF kinase mutations activate a cell proliferation pathway that is critical in many cancers (MAP kinase pathway)4, 5. Over 45 cancer-associated BRAF mutations have been identified6. The two most prominent BRAF mutations are V600E and V600K. These mutations lock the BRAF kinase in its active status, increasing its activity nearly 10-fold7. The V600E substitution represents nearly 90% of all identified BRAF mutations that occur in human cancer and accounts for 70 to 90% of BRAF mutant melanoma patients. The V600K mutation is found in an additional 6 to 29% of patients with a BRAF mutation8.

Theranostics :

With the discovery of role BRAF mutation in Metastatic Melanoma, a Theranostics approach is now possible thanks to the combination of:

  • targeting patients by BRAF V600E and V600K mutation detection
  • and treatment with BRAF inhibitors and MEK inhibitors

THXID®-BRAF provides added medical value and healthcare savings by providing clinicians with more personalized information so they can target the right patient10, 11, 12, 13.

THXID® BRAF: A combination of automation and molecular biology

Easily integrated into the laboratory, THXID® BRAF provides fast and accurate results for confident decisions.

  • A complete kit from sample preparation to data analysis
  • For the detection and identification of the BRAF V600E and V600K mutations
    • Fast : time to results within 6 hours
    • Accurate : 98 % of positive agreement vs Sanger Sequencing in BRAF V600 E and V600K mutation detection
    • Automated
  • Simple, Streamlined Workflow for Accurate BRAF Mutation Analysis:
    • Sample Preparation
    • Real-Time PCR Amplification
    • BRAF V600 Mutation Status Report

Regulatory status: THXID® BRAF is both CE IVD and US IVD

  1. Skin Cancer Foundation. “What Is Melanoma?” Available at http://www.skincancer.org/skin-cancer-information/melanoma.
  2. GLOBOCAN 2008
  3. Ferlay J, Parkin DM, Steliarova-Foucher E, et al. Estimates of cancer incidence and mortality in Europe in 2008. Eur J Cancer 2010;46:765-81
  4. Wan PT, Garnett MJ, Roe SM, et al. Mechanism of activation of the RAF-ERK signaling pathway by oncogenic mutations of B-RAF.Cell 2004;116:855-67.
  5. Herbst RS, Heymach J, Lippman S. Lung cancer. N Engl J Med. 2008;359:1367-80.
  6. Wellbrock C, Karasarides M, Marais R, et al. The RAF proteins take center stage Nat Rev Mol Cell Biol. 2004;5:875-885
  7. Davies H, Bignell GR, Cox C, et al. Mutations of the BRAF gene in human cancer. Nature 2002;417:949-54.
  8. Rubinstein J, Sznol M, Pavlick AC, et al. Incidence of the V600K mutation among melanoma patients with BRAF mutations, and potential therapeutic response to the specific BRAF inhibitor PLX4032. J Transl Med. 2010;8:67
  9. Hauschild A, Grob JJ, Demidov LV, et al. Phase III, randomized, open-label, multicenter trial (BREAK-3) comparing the BRAF kinase inhibitor dabrafenib (GSK2118436) with dacarbazine (DTIC) in patients with BRAFV600E-mutated melanoma. J Clin Oncol. ASCO 2012;30 (suppl; abstr. LBA8500).
  10. Robert C, Flaherty KT, Hersey P, et al. METRIC phase 3 study: efficacy of trametinib, a potent and selective MEK inhibitor (MEKi), in progression-free survival (PFS) and overall survival (OS), compared with chemotherapy (C) in patients with BRAFV600E/K mutant advanced or metastatic melanoma. J Clin Oncol. ASCO 2012;30 (suppl; abstr LBA8509).
  11. Becerra C, Salazar R, Garcia-Carbonero R, et al. Phase II trial of figitumumab in patients with refractory, metastatic colorectal cancer (mCRC). J Clin Oncol. ASCO 2011;29 (suppl; abstr 3525).
  12. Kirkwood JM, Long GV, Trefzer U, et al. BREAK-MB: a phase II study assessing overall intracranial response rate (OIRR) to dabrafenib (GSK2118436) in patients (pts) with BRAF V600E/k mutation-positive melanoma with brain metastases (mets). J Clin Oncol. ASCO 2012;30 (suppl; abstr 8501)

Please consult your local bioMérieux representative for product availability in your country

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