Diadexus, Inc. announced results from the PLAC Test for Lp-PLA2 Activity (PLAC Activity Test) clinical validation study, presented for the first time during an oral presentation at the European Atherosclerosis Society 83rd Congress in Glasgow, UK. The results from this study were used in the 510(k) submission for this new test, which was cleared by the U.S. Food and Drug Administration in December 2014 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. Results showed: The study cohort included 615 subjects with a CHD event and 3,686 subjects who remained free of CHD during a follow-up period of 5.3 years.

The unadjusted hazard ratio (HR) of elevated Lp-PLA2 Activity levels for CHD events was 1.60 (95% CI: 1.31-1.97), and 1.46 (95% CI: 1.14, 1.97) after adjustment for age, sex, hypertension, diabetes, smoking, LDL and HDL cholesterol.