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diaDexus Receives CE Mark Certification for the PLAC(R) Test
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SOUTH SAN FRANCISCO, Calif., Dec. 1 /PRNewswire/ -- diaDexus, Inc. todayannounced that it received CE Mark approval for the automated format of thePLAC Test for Lp-PLA2. This automated format of the PLAC(R) Test, capable ofrunning on a wide range of clinical chemistry analyzers, was also cleared bythe U.S. Food & Drug Administration (FDA) in December 2007. diaDexus alsoannounced 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 forboth coronary heart disease (CHD) and ischemic stroke associated withatherosclerosis. The PLAC Test measures lipoprotein-associated phospholipaseA2 (Lp-PLA2), a vascular-specific inflammatory enzyme implicated in theformation of rupture-prone plaque. It is plaque rupture and thrombosis, notstenosis, that cause the majority of cardiac events. Clinical researchdemonstrates that early diagnosis of cardiovascular disease improves thelikelihood of preventing these events.
According to Patrick Plewman, president and CEO of diaDexus, CE Markingfor the automated PLAC Test is another milestone for the company. "Over twomillion people in the 27 EU Member States die of cardiovascular disease eachyear; heart disease is the leading cause of death, and stroke is third.Working closely with our distribution partners in the EU, diaDexus iscommitted to expanding access to the PLAC Test in Europe to help identifyindividuals at increased risk of suffering a heart attack or stroke," Plewmansaid.
"It is well documented that traditional risk factors fail to identify manypeople at risk for developing cardiovascular disease," said Professor WolfgangKoenig, M.D., Internal Medicine Department II, University of Ulm, Germany."The PLAC Test provides us with information we've never had before about apatient's risk for coronary heart disease and ischemic stroke helping todetermine the best course of treatment to prevent these events from occurring.Lp-PLA2 has similar predictive power for both primary coronary heart diseasein initially healthy subjects, as well as for recurrent events in those withclinically manifest atherosclerosis."
About diaDexus
diaDexus, Inc., a privately held diagnostics company based in South SanFrancisco, is focused on the development and commercialization ofpatent-protected in vitro diagnostic products addressing unmet needs incardiovascular disease. For more information, visit http://www.plactest.com orhttp://www.diaDexus.com.
SOURCE diaDexus, Inc.
According to Patrick Plewman, president and CEO of diaDexus, CE Markingfor the automated PLAC Test is another milestone for the company. "Over twomillion people in the 27 EU Member States die of cardiovascular disease eachyear; heart disease is the leading cause of death, and stroke is third.Working closely with our distribution partners in the EU, diaDexus iscommitted to expanding access to the PLAC Test in Europe to help identifyindividuals at increased risk of suffering a heart attack or stroke," Plewmansaid.
"It is well documented that traditional risk factors fail to identify manypeople at risk for developing cardiovascular disease," said Professor WolfgangKoenig, M.D., Internal Medicine Department II, University of Ulm, Germany."The PLAC Test provides us with information we've never had before about apatient's risk for coronary heart disease and ischemic stroke helping todetermine the best course of treatment to prevent these events from occurring.Lp-PLA2 has similar predictive power for both primary coronary heart diseasein initially healthy subjects, as well as for recurrent events in those withclinically manifest atherosclerosis."
About diaDexus
diaDexus, Inc., a privately held diagnostics company based in South SanFrancisco, is focused on the development and commercialization ofpatent-protected in vitro diagnostic products addressing unmet needs incardiovascular disease. For more information, visit http://www.plactest.com orhttp://www.diaDexus.com.
SOURCE diaDexus, Inc.
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