diaDexus, Inc. announced that it has received notice from the U.S. Food and Drug Administration (FDA) that an administrative acceptance review was conducted on the traditional 510(k) submission of the PLAC Test for Lp-PLA(2) Activity, and it was found to contain all of the necessary information needed to proceed with the substantive review. The PLAC Test for Lp-PLA(2) Activity is an enzyme assay for the quantitative determination of Lp-PLA(2) (Lipoprotein-Associated Phospholipase A(2)) activity in human plasma and serum. Lipoprotein-Associated Phospholipase A(2) (Lp-PLA(2)) is a vascular-specific inflammatory marker that is critical in the formation of rupture-prone plaque.

When elevated, this enzyme indicates arterial inflammation, which is associated with increased risk for cardiovascular disease. The PLAC Tests are simple blood tests that measure Lp-PLA(2) levels in a patient's blood. diaDexus has developed and commercialized two PLAC Tests.

The PLAC Test ELISA Kit is cleared by the FDA as an aid in predicting risk for coronary heart disease and ischemic stroke associated with atherosclerosis and is commercially available in the United States. The PLAC Test for Lp-PLA(2) Activity is CE-marked and available in the European Union; this test has not been cleared by the FDA.