SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--diaDexus, Inc., today announced that the U.S. Food & Drug Administration (FDA) has cleared for marketing a new automated version of its proprietary PLAC® Test. The new PLAC Test format, based on immunoturbidimetric technology, is an automated immunoassay designed to run on common existing laboratory equipment, including clinical chemistry analyzers from Hitachi, Roche/Hitachi, and Olympus, significantly expanding the number of clinical labs and physician offices that are able to offer the PLAC Test. According to Patrick Plewman, president and chief executive officer of diaDexus, this new format of the PLAC Test will play a critical role in the company’s ongoing commitment to the early detection of those at increased risk of stroke and heart disease. The PLAC Test is a simple blood test that measures lipoprotein-associated phospholipase A2 (Lp-PLA2), an enzyme specific to vascular inflammation implicated in the formation of rupture-prone plaque. The PLAC Test is the only blood test cleared by the FDA to aid in assessing risk of both coronary heart disease and ischemic stroke associated with atherosclerosis. This new PLAC Test format is manufactured for diaDexus by Denka Seiken, based in Tokyo, a leading global diagnostics manufacturer.
