FDA approves Lp-PLA2 test for CHD

Laurent Castellucci

July 21, 2003

Mon, 21 Jul 2003 18:00:00

San Francisco, CA - The FDA has granted market clearance to a lipoprotein-associated phospholipase A2 (Lp-PLA2) test for coronary heart disease (diaDexus Inc).

The test, called PLACTM, is marketed as a way to identify patients at risk who do not have elevated LDL levels. Results from the ARIC study, presented by Dr Christie M Ballantyne (Baylor College of Medicine, Houston, TX) at the American College of Cardiology 2003 Scientific Sessions (and reported previously on heartwire ), show that individuals with normal LDL but elevated levels of Lp-PLA2 are roughly twice as likely to experience a coronary event as those individuals with normal levels of both LDL and Lp-PLA2 and that the risk is even higher for patients with elevated levels of both Lp-PLA2 and CRP.

"Receiving marketing clearance for the PLAC test represents an important milestone for diaDexus," said Patrick Plewman (diaDexus) in a press statement. "There is significant market potential for a product that helps identify patients at risk for CHD who are not currently identified by traditional risk factors."

According to the company, research is currently under way to evaluate the effects of statin therapy on Lp-PLA2 levels. In addition, GlaxoSmithKline is developing an inhibitor to Lp-PLA2 as a potential treatment for atherosclerosis. This inhibitor is currently in phase 2 clinical trials.

Related links

1. [HeartWire > News; Apr 4, 2003]

2. [HeartWire > News; Oct 19, 2000]



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