QIAGEN announces European launch of therascreen® IDH1/2 test for gliomas as well as an IDH1/2-related collaboration with Mayo Clinic
- QIAGEN’s therascreen® IDH1/2 RGQ Kit is the first CE-marked test targeting IDH1 and IDH2 biomarkers to diagnose brain gliomas and assess prognosis
- Partnership with Mayo Clinic aims at developing tools for personalized medicine in cholangiocarcinoma, or bile duct cancer
HILDEN, Germany, and MARSEILLE, France, January 06, 2013 — 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.
Excellence in Personalized Healthcare
QIAGEN is a leading partner globally in developing and validating companion diagnostics to guide the selection of medicines in treating cancer and other diseases. Since July 2012, QIAGEN has received FDA approval for the therascreen® KRAS RGQ PCR Kit as a companion diagnostic in patients with metastatic colorectal cancer and the therascreen® EGFR RGQ PCR Kit in patients with non-small cell lung cancer. The U.S. rollout of therascreen KRAS and EGFR builds on a strong global leadership position including successes in Japan, where regulators approved the therascreen KRAS and EGFR kits in 2011, and in Europe, where QIAGEN offers 15 CE-marked assays for personalized healthcare applications. QIAGEN has more than 15 projects under way to co-develop and market companion diagnostics with leading Pharma and biotech companies.
About QIAGEN Marseille
QIAGEN Marseille develops molecular diagnostic tests designed to map diseases in order to guide patients and oncologists’ decisions along their complex therapeutic path. With more than 60 tests already used routinely worldwide for the diagnosis, prognosis and follow-up of thousands of patients with blood cancer, QIAGEN Marseille is also developing diagnostic tools targeting other cancers. Its goal is to provide information, remaining unavailable until now, to sustain the development of personalized medicine.
QIAGEN N.V. is a Netherlands holding company publically traded on NASDAQ and Frankfurt Prime Standard. The Company is the leading global provider of Sample & Assay Technologies that are used to transform biological materials into valuable molecular insights. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue. Assay technologies are then used to make these isolated biomolecules visible and ready for interpretation. QIAGEN markets more than 500 products around the world, selling both consumable kits and automation systems to customers through four customer classes: Molecular Diagnostics (human healthcare), Applied Testing (forensics, veterinary testing and food safety), Pharma (pharmaceutical and biotechnology companies) and Academia (life sciences research). As of September 30, 2013, QIAGEN employed more than 4,100 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
Certain of the statements contained in this news release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN's products, markets, strategy or operating results, including without limitation its expected operating results, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products in applied testing, personalized healthcare, clinical research, proteomics, women's health/HPV testing and nucleic acid-based molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN's products (including fluctuations due to general economic conditions, the level and timing of customers' funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN's products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors' products; market acceptance of QIAGEN's new products, the consummation of acquisitions, and the integration of acquired technologies and businesses. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC)