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DIADEXUS ANNOUNCES SUBMISSION OF 510 (K) PRE-MARKET NOTIFICATION Marketing clearance sought for the PLACT Test, a risk assessment tool for coronary heart disease South San Francisco, CA - March 5, 2003 - diaDexus, Inc., a privately held biotechnology company based in So. San Francisco, today announced submission of a 510(k) Premarket Notification to the U.S. Food and Drug Administration. The Company is seeking marketing clearance for the PLACT test as an in vitro diagnostic product to predict the risk for coronary artery disease. The PLAC test is a quantitative measurement of lipoprotein-associated phospholipase A2, or Lp-PLA2, in blood. Lp-PLA2 has been previously described as a novel risk factor for coronary heart disease in a paper published in the New England Journal of Medicine. "It is well established that a significant proportion of individuals who suffer a heart attack have no previous signs or symptoms of coronary heart disease such as elevated cholesterol," said Patrick Plewman, chief executive officer of diaDexus. "There is clearly a need for additional tests to accurately identify those at risk. We believe the PLAC test will help to identify patients at risk for coronary heart disease." diaDexus, a privately held biotechnology company, based in So. San Francisco, Calif., is focused on the discovery, development, and commercialization of novel, patent-protected diagnostic and therapeutic products with high potential clinical value. diaDexus utilizes genomics and bioinformatics to identify numerous disease-associated molecular targets. More information about the company may be found at www.diaDexus.com. |
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