Pharmaceutical Business review

diaDexus wins CE Mark for PLAC test

The PLAC test is said to be the only blood test cleared by the FDA to assess risk for both coronary heart disease and ischemic stroke associated with atherosclerosis. The PLAC test measures lipoprotein-associated phospholipase A2 (Lp-PLA2), a vascular-specific inflammatory enzyme implicated in the formation of rupture-prone plaque.

Patrick Plewman, president and CEO of diaDexus, said: Working closely with our distribution partners in the EU, diaDexus is committed to expanding access to the PLAC test in Europe to help identify individuals at increased risk of suffering a heart attack or stroke.

Wolfgang Koenig, professor in internal medicine department II, University of Ulm, Germany, said: The PLAC test provides us with information we’ve never had before about a patient’s risk for coronary heart disease and ischemic stroke helping to determine the best course of treatment to prevent these events from occurring.

Lp-PLA2 has similar predictive power for both primary coronary heart disease in initially healthy subjects, as well as for recurrent events in those with clinically manifest atherosclerosis.