FROM PR NEWSWIRE: QIAGEN Teams with China’s Lepu Medical to Provide Rapid Diagnosis of Heart Attacks Using Point of Need Testing BEIJING, China, and HILDEN, Germany, September 13, 2012 /PRNewswire/ — — QIAGEN’s cutting-edge ESEQuant Lateral Flow System will run Lepu Medical’s tests for key cardiac biomarkers to deliver lifesaving information in emergency rooms — Cardiac testing adds further momentum for QIAGEN in fast-growing Chinese market — Pioneering ESEQuant platform achieves first regulatory approval in human healthcare, expanding QIAGEN’s global Point of Need business QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced an agreement with Lepu Medical Technology (Beijing) Co., Ltd., a leading medical device company in China, to provide QIAGEN’s ESEQuant Lateral Flow System for use in emergency rooms with Lepu’s tests for cardiac markers that diagnose acute myocardial infarction (heart attack). The agreement expands QIAGEN’s presence in China and adds a new point of need diagnostics application.
China’s State Food and Drug Administration (SFDA) has approved the ESEQuant Lateral Flow detection system with Lepu Medical’s five cardiac marker tests. Lepu will market the system in China under the name LEPU Quant-Gold. Globally, this is the first regulatory approval in human healthcare for QIAGEN’s pioneering ESEQuant platform which was acquired in 2010.
“We are very pleased to begin this relationship with the Lepu Group and meet a pressing need for heart patients by combining ESEQuant’s quick turnaround time with the reliability of Lepu’s tests for cardiac biomarkers,” said Dr. Frank Krieg-Schneider, Head of Global Strategic Alliances & OEM at QIAGEN. “This agreement advances two strategic initiatives: First, our geographic presence is further broadened by the addition of important point of need assays in China. China today represents QIAGEN’s third-largest country in sales. Secondly, we are driving platform success by launching ESEQuant as an SFDA-approved device in a lifesaving medical application, a milestone for our emerging Point of Need portfolio.” QIAGEN’s Point of Need portfolio is rapidly expanding. The growth is based on the benefits of the revolutionary ESE platform portfolio as well as on the value of the pipeline and portfolio of molecular and other assays for these platforms. Earlier in 2012 QIAGEN acquired the AmniSure immunoassay for rupture of amniotic membranes in pregnant women, a self-contained test used in doctor’s offices and maternity units, and joined a global initiative with the Bill and Melinda Gates Foundation to create much-needed platforms for point of care diagnosis in the developing world. “Our vision for point of need is to bring the speed and reliability of advanced diagnostics into emergency rooms, physician offices and other places where care is given without immediate access to laboratories”, Dr. Krieg-Schneider added.
The agreement with Lepu Medical begins with shipment of 750 ESEQuant systems for China and is expected to grow. The need in emergency rooms is for quick response with appropriate treatments, since patients suffering heart attacks face the greatest risk of death in the first hour. Currently, ambulance personnel take samples to test for cardiac markers, and upon arrival at the hospital these are sent to a laboratory – a delay of an hour or more. QIAGEN’s ESEQuant platform will run Lepu’s tests to measure key cardiac markers immediately after the ambulance arrives at the emergency room, allowing accurate diagnosis within minutes at the point of care – a lifesaving improvement. China has more than 14,000 public hospitals and an additional 5,700 private hospitals, according to 2009 public data.
As QIAGEN continues to expand its presence in China, the Lepu Medical relationship builds upon other major instrument supply agreements, including Hangzhou Proprium Biotech Co., Ltd. in the field of cancer diagnostics.
About Lepu: Established in 1999, Lepu Medical Technology (Beijing) Co., Ltd. is specialized in high-tech medical device development, production and sales. Lepu has built up a leading group company concentrating in cardiac therapy, with products including interventional cardiology, occlusion devices, prosthetic heart valves, pacemaker, cardiac in vitro diagnosis products, angiographic equipment and anesthetic products. In October 2009, Lepu successfully listed on ChiNext of Shenzhen Stock Exchange market (stock symbol 300003: CH).
About QIAGEN: 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 June 30, 2012, QIAGEN employed approximately 4,000 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).