US-based diaDexus has secured 510(k) clearance from 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 quantitative determination of Lp-PLA2 activity in human plasma and serum.
An analysis based on REGARDS showed elevated Lp-PLA2 activity levels are associated with a significant increase for risk of coronary heart disease.
REGARDS is a longitudinal trial funded by US-based National Institutes of Health (NIH) and included a group of 4,500 individuals with no prior history of cardiovascular events.
Chairman of the board at diaDexus 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.
"This new PLAC Activity test has demonstrated robust analytical performance and can be used broadly by moderate-complexity reference labs, hospital labs, and physician office labs using a wide range of typical clinical chemistry analysers, allowing us to meaningfully expand our customer base."
The company said the first indication for the new test is for use in conjunction with clinical evaluation and patient risk assessment as an aid in predicting the risk of coronary heart disease (CHD) in patients with no prior history of cardiovascular events.
PLAC Tests are simple blood tests, which measure Lp-PLA2 levels in a patient’s blood, while the company developed and commercialised two FDA cleared PLAC Tests.