diaDexus, Inc. (OTCMKTS:DDXS) a diagnostics firm working on the development and commercialization of products that help in the assessment of cardiac disease risk disclosed results from the PLAC® Test. It was related with the Lp-PLA2 Activity clinical validation study. The results were disclosed for the first time in a presentation at the ‘European Atherosclerosis Society.’
The significance
The study results were utilized in the 510(k) submission for the new trial, which was approved by the U.S. FDA in last December for use in combination with clinical assessment and patient risk evaluation as a help in assessing risk of coronary heart disease in patients with no previous history of cardiovascular events.
The data set
The study of diaDexus covered the largest data group in people without any baseline cardiovascular disease to exhibit a relationship between increased Lp-PLA2 Activity and the risk of CHD. The clinical validation trial was performed with a vigilant adjudication of events. It reflected no difference in the risk forecast among subpopulations based on race, age or gender. Lp-PLA2 Activity levels clinical performance plays an important role in primary prevention.
The results
diaDexus said that study based on a cohort of almost 4,000 enrollments with no previous history of cardiovascular events included in the REGARDS Study demonstrated that increased Lp-PLA2 Activity levels are linked with a noteworthy increased risk of CHD cases occurring over a 5-year period. REGARDS is an NIH-funded longitudinal study.
The performance
Kenneth C. Fang, M.D., the Chief Medical Officer for diaDexus, Inc. (OTCMKTS:DDXS) said that the performance of PLAC Activity in Study group based upon the defined body of peer-reviewed literature justifying the implication of Lp-PLA2 for predicting coronary heart disease risk. The Activity Test shows strong analytical performance and gives incremental data about future coronary heart disease cases for at-risk individuals without a prior history. The oral presentation was given on March 24, 2015.
