QIAGEN N.V. 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.