SOUTH SAN FRANCISCO, Calif., Dec. 1 CA-diaDexus-PLAC-Test
SOUTH SAN FRANCISCO, Calif., Dec. 1 /PRNewswire/ -- diaDexus, Inc. today
announced that it received CE Mark approval for the automated format of the
PLAC Test for Lp-PLA2. This automated format of the PLAC(R) Test, capable of
running on a wide range of clinical chemistry analyzers, was also cleared by
the U.S. Food & Drug Administration (FDA) in December 2007. diaDexus also
announced the first shipment of the CE Marked PLAC Test to Europe.
The PLAC Test is the only blood test cleared by the FDA to assess risk for
both coronary heart disease (CHD) 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. It is plaque rupture and thrombosis, not
stenosis, that cause the majority of cardiac events. Clinical research
demonstrates that early diagnosis of cardiovascular disease improves the
likelihood of preventing these events.
According to Patrick Plewman, president and CEO of diaDexus, CE Marking
for the automated PLAC Test is another milestone for the company. "Over two
million people in the 27 EU Member States die of cardiovascular disease each
year; heart disease is the leading cause of death, and stroke is third.
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," Plewman
said.
"It is well documented that traditional risk factors fail to identify many
people at risk for developing cardiovascular disease," said Professor Wolfgang
Koenig, M.D., Internal Medicine Department II, University of Ulm, Germany.
"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."
About diaDexus
diaDexus, Inc., a privately held diagnostics company based in South San
Francisco, is focused on the development and commercialization of
patent-protected in vitro diagnostic products addressing unmet needs in
cardiovascular disease. For more information, visit http://www.plactest.com or
http://www.diaDexus.com.
SOURCE diaDexus, Inc.
