diaDexus Receives FDA Approval for Automated PLAC Test
The FDA cleared for marketing a new automated version of diaDexus’ proprietary PLAC Test, an automated immunoassay designed to run on common existing laboratory equipment, including clinical chemistry analyzers from Hitachi,
Roche/Hitachi and Olympus, expanding the number of clinical labs and physician offices that are able to offer the PLAC Test.
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 one of the only blood tests cleared by the FDA to aid in assessing risk of both coronary heart disease and ischemic stroke associated with atherosclerosis, said the company.