SOUTH SAN FRANCISCO, California, December 1 /PRNewswire/ --
diaDexus, Inc. today announced that it received CE Mark approval for the automated format of the PLAC Test for Lp-PLA2. This automated format of the PLAC(R) Test, capable of running on a wide range of clinical chemistry analyzers, was also cleared by the U.S. Food Drug Administration (FDA) in December 2007. diaDexus also announced the first shipment of the CE Marked PLAC Test to Europe.
The PLAC Test is the only blood test cleared by the FDA to assess risk for both coronary heart disease (CHD) and ischemic stroke associated with atherosclerosis. The PLAC Test measures lipoprotein-associated phospholipase A2 (Lp-PLA2), a vascular-specific inflammatory enzyme implicated in the formation of rupture-prone plaque. It is plaque rupture and thrombosis, not stenosis, that cause the majority of cardiac events. Clinical research demonstrates that early diagnosis of cardiovascular disease improves the likelihood of preventing these events.
According to Patrick Plewman, president and CEO of diaDexus, CE Marking for the automated PLAC Test is another milestone for the company. Over two million people in the 27 EU Member States die of cardiovascular disease each year; heart disease is the leading cause of death, and stroke is third. Working closely with our distribution partners in the EU, diaDexus is committed to expanding access to the PLAC Test in Europe to help identify individuals at increased risk of suffering a heart attack or stroke, Plewman said.
It is well documented that traditional risk factors fail to identify many people at risk for developing cardiovascular disease, said Professor Wolfgang Koenig, M.D., Internal Medicine Department II, University of Ulm, Germany. The PLAC Test provides us with information we've never had before about a patient's risk for coronary heart disease and ischemic stroke helping to determine the best course of treatment to prevent these events from occurring. Lp-PLA2 has similar predictive power for both primary coronary heart disease in initially healthy subjects, as well as for recurrent events in those with clinically manifest atherosclerosis.
About diaDexus
diaDexus, Inc., a privately held diagnostics company based in South San Francisco, is focused on the development and commercialization of patent-protected in vitro diagnostic products addressing unmet needs in cardiovascular disease. For more information, visit http://www.plactest.com or http://www.diaDexus.com.
Sarah Schiltz, Director of Marketing of diaDexus, Inc., +1-650-246-6447
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