QIAGEN announces European launch of therascreen® IDH1/2 test for gliomas

Mon, 01/06/2014 - 4:48pm
The Associated Press
  • QIAGEN's therascreen® IDH1/2 RGQ Kit is the first CE-marked test targeting IDH1 and IDH2 biomarkers to diagnose brain gliomas and assess prognoses
  • Partnership with Mayo Clinic aims to develop tools for personalized medicine in cholangiocarcinoma, or bile duct cancer

QIAGEN N.V. today announced the European launch of its new therascreen® IDH1/2 RGQ Kit, enabling physicians to better diagnose and assess the prognoses of patients with gliomas, or tumors of the brain and  spinal cord. The test is based on QIAGEN's proprietary biomarkers for IDH1 and IDH2 gene mutations. The therascreen® IDH1/2 RGQ Kit has received CE marking enabling marketing in Europe and certain other markets. In addition, QIAGEN announced a new collaboration with Mayo Clinic to develop diagnostics for cholangiocarcinoma (CCA), also known as bile duct cancer, using biomarkers for the IDH1 and IDH2 mutations.

The therascreen IDH1/2 RGQ PCR Kit enables detection of 12 mutations in the IDH1 and IDH2 genes in a single test using real-time PCR. Mutations in IDH1/2 are recognized as prognostic markers for gliomas (NCCN 2013, EFNS 2010), and the therascreen IDH1/2 RGQ PCR Kit will aid clinicians in classifying the tumors and prognosticating the course of this serious disease.

"We are pleased to introduce a standardized, reliable IDH1/2 diagnostic test that improves clinical understanding and treatment of gliomas by genetically characterizing each person's disease. QIAGEN's assay for IDH1/2 mutations was designed in close collaboration with leading clinicians to rapidly provide meaningful information about their patients' gliomas," said Vincent Fert, QIAGEN's Personalized Healthcare Program Leader. "This new product strengthens QIAGEN's Personalized Healthcare portfolio, especially the assay offering for neuro-oncology, which also include CE-marked therascreen MGMT and BRAF tests. The IDH1/2 kit also adds to the growing menu of tests that run on our flexible sample-to-result QIAsymphony platform which allows an improved laboratory workflow."

QIAGEN also announced a partnership and licensing options with Mayo Clinic in Rochester, Minnesota, for use of the IDH1 and IDH2 biomarkers to diagnose and guide the treatment of cholangiocarcinoma. CCA is a rare form of cancer, originating in the bile duct that affects approximately 2,000 to 3,000 patients each year in the United States. QIAGEN and Mayo Clinic, which was also involved in the validation study of the new therascreen® IDH1/2 RGQ Kit, will collaborate on development of new IDH1/2 products for CCA.



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