FDA grants marketing clearance for diaDexus's PLAC Test

diaDexus, Inc., a diagnostics company focused on the development and commercialization of patent-protected in vitro diagnostic products addressing unmet needs in cardiovascular disease, today announced that the U.S. Food and Drug Administration (FDA) has cleared for marketing the automated version of its proprietary PLAC® Test. This PLAC Test product format, based on turbidimetric immunoassay (TIA) technology, is designed to run on most clinical chemistry analyzers, significantly expanding the number of clinical labs and physician offices that are able to offer the PLAC Test.

"We are pleased to have this format of our PLAC Test cleared by the FDA. This new automated TIA version addresses the heterophilic interference found in the previous version. We expect to launch the new version of the PLAC Test next quarter," said Patrick Plewman, president and chief executive officer of diaDexus.