QIAGEN adds promising new biomarker to pipeline of Personalized Healthcare assays to improve diagnosis of blood disorders
- Reliable diagnostic tools under development for mutations of calreticulin (CALR) are expected to benefit patients with blood disorders known as myeloproliferative neoplasms
- QIAGEN acquired exclusive worldwide license for CALR biomarker from CeMM Vienna, whose researchers recently published the discovery in the New England Journal of Medicine
- Addition of CALR biomarker expands market-leading position in Personalized Healthcare in blood disorders, which includes JAK2, BCR-ABL and other assays
HILDEN, Germany, and VIENNA, Austria, April 10, 2014 — QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced it has acquired an exclusive worldwide license to the biomarker calreticulin (CALR), whose recently discovered mutations are found in an estimated 15% of cases of myeloproliferative neoplasms (MPNs), a group of blood disorders. QIAGEN licensed the technology from CeMM Vienna, the Research Center for Molecular Medicine of the Austrian Academy of Sciences, whose scientists led a team that discovered the presence of mutations of the CALR protein in MPNs. QIAGEN plans to develop a molecular diagnostic test for the CALR mutations to offer each patient a clearer prognostic profile and to guide disease management. Development of a CALR diagnostic test is expected to be highly complementary to QIAGEN’s kits for a key mutation of the Janus kinase 2 (JAK2) gene.
Myeloproliferative neoplasms, a group of blood disorders involving overproduction of blood cells, are chronic diseases that can lead to several complications including thrombosis (blood clots) and in some cases difficult-to-treat acute leukemia. QIAGEN already has an exclusive license for the JAK2 V617F mutation, which is present in about 75% of patients with MPNs. According to an article published in the New England Journal of Medicine in December 2013 by the CeMM team led by Robert Kralovics, patients with CALR mutations suffer from a milder form of the disease than those with the JAK2V617F mutation, including a lower risk of thrombosis and a higher survival rate.
"This novel biomarker offers an exciting opportunity to broaden QIAGEN’s market-leading position in developing molecular diagnostics for the whole range of blood disorders. Together, the JAK2 and CALR biomarkers give us the ability to deliver personalized insights regarding diagnosis, prognosis and disease management for patients with myeloprofilerative disorders," said Peer M. Schatz, Chief Executive Officer of QIAGEN. “We are now looking forward to developing clinically proven tests for detection of CALR mutations on Rotor-Gene Q MDx, which is part of our industry-leading QIAsymphony family of automated platforms. CALR and JAK2 could also be promising targets for companion diagnostics as future drug candidates for these blood disorders may be linked to these biomarkers.”
Giulio Superti-Furga, Scientific Director of CeMM, said: “We estimate that up to 3 million people worldwide suffer from myeloproliferative neoplasms, and discovery of the CALR mutation by our CeMM and Medical University of Vienna research teams is a very important finding for the benefit of these patients. We are pleased to license the CALR biomarker to QIAGEN. The development of a standardized test will enable physicians to provide improved patient care. At the same time, our researchers will continue to advance the understanding of these diseases and to focus on developing novel treatment options. CeMM is constantly investing in basic research aimed at obtaining new insights in potential diagnostics and therapeutics.”
With the technologies licensed from CeMM, QIAGEN plans to develop commercial kits for the detection of CALR mutations and seek regulatory approvals for those products. These diagnostics will join the growing portfolio of kits designed to run on the QIAsymphony automation platform. In addition, the license from CeMM includes potential use of the biomarker in next-generation sequencing applications.
QIAGEN N.V., a Netherlands holding company, is the leading global provider of Sample & Assay Technologies that are used to transform biological materials into valuable molecular information. 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 December 31, 2013, QIAGEN employed approximately 4,000 people in more than 35 locations worldwide. Further information can be found at 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).