diaDexus Inc. announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for its PLAC(R) Test for Lp-PLA2 Activity. This new test is an enzyme assay for the quantitative determination of Lp-PLA2 (Lipoprotein-Associated Phospholipase A2) activity in human plasma and serum. An analysis based on REGARDS, a U.S.-based National Institutes of Health (NIH)-funded longitudinal study, using a cohort of approximately 4,500 individuals with no prior history of cardiovascular events, demonstrated that elevated Lp-PLA2 Activity levels are associated with a significant increase for risk of coronary heart disease.

The first indication for the new test is for use in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk of coronary heart disease (CHD) in patients with no prior history of cardiovascular events, which is approximately 75% of this population. To commercialize this new test, diaDexus will use its established salesforce. Beginning in the first quarter of 2015, the company expects to start contracting and enabling new lab customers.

Utilizing an established salesforce and a multi-faceted education-based strategy, diaDexus expects to begin providing laboratory customers and physicians appropriate information on the benefits of using PLAC testing for patient risk assessment. Evidence supporting the clinical utility of PLAC Activity was based on data from the Reasons for Geographic and Racial Differences in Stroke (REGARDS) study as well as the substantial peer-reviewed literature supporting Lp-PLA2 as an important cardiovascular risk marker. Demand is expected to be generated as physicians become familiar with and begin to order the test from diaDexus' lab customers.