August 21, 2014 — diaDexus announced it has received notice from the U.S. Food and Drug Administration (FDA) that an administrative acceptance review was conducted on the traditional 510(k) submission of the PLAC Test for Lp-PLA2 Activity, and it was found to contain all of the necessary information needed to proceed with the substantive review. The PLAC Test for Lp-PLA2 Activity is an enzyme assay for the quantitative determination of Lp-PLA2 (Lipoprotein-Associated Phospholipase A2) activity in human plasma and serum.
“We have been working closely with the FDA through the pre-submission process to determine a path forward to obtain U.S. clearance for the Activity Test, and we are pleased that we are now one step closer in the regulatory process,” said Emi Zychlinsky, Ph.D., chief technical officer of diaDexus. “We have been focused on adding the PLAC test for Lp-PLA2 Activity to our product offering as it is performed on high throughput clinical chemistry analyzers and is designed to improve productivity and increase value for all of our customers, both cardiovascular specialty laboratories and large clinical laboratories.”
Lipoprotein-Associated Phospholipase A2 (Lp-PLA2) is a vascular-specific inflammatory marker that is critical in the formation of rupture-prone plaque. When elevated, this enzyme indicates arterial inflammation, which is associated with increased risk for cardiovascular disease.
The PLAC Tests are simple blood tests that measure Lp-PLA2 levels in a patient’s blood. diaDexus has developed and commercialized two PLAC tests. The PLAC Test ELISA Kit is cleared by the FDA as an aid in predicting risk for coronary heart disease and ischemic stroke associated with atherosclerosis and is commercially available in the United States. The PLAC Test for Lp-PLA2 Activity is CE marked and available in the European Union; this test has not been cleared by the FDA.
For more information: www.diadexus.com