Cardiovascular diagnostic products developer diaDexus has received 510(k) approval from the US Food and Drug Administration (FDA) for its PLAC Test for Lipoprotein-Associated Phospholipase A2 (Lp-PLA2) Activity.
The new test is an enzyme assay developed for the quantitative determination of Lp-PLA2 activity in human plasma and serum.
diaDexus board chairman and interim executive chair Lori Rafield said: "The FDA’s clearance of our second test is an important step in achieving our vision of evolving from a single-product business into a multi-product company.
"Our PLAC tests, ELISA and now Activity, are the only FDA-cleared Lp-PLA2 tests to help identify the hidden risk of coronary heart disease, which includes heart attack."
According to the company, 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.
The PLAC Tests are simple blood tests, which measure Lp-PLA2 levels in a patient’s blood, while the company has developed and commercialized two FDA-cleared PLAC Tests.