Healthcare Industry News:  Olympus 

DIagnostics Cardiology FDA

 News Release - February 19, 2008

diaDexus Receives FDA Clearance for Automated Blood Test That Identifies Stroke & Heart Attack Risk

New Format of the PLAC(R) Test Quickly & Cost-Effectively Measures Key Marker of Rupture-Prone Plaque

SOUTH SAN FRANCISCO, Calif.--(HSMN NewsFeed)--diaDexus, Inc., today announced that the U.S. Food & Drug Administration (FDA) has cleared for marketing a new automated version of its proprietary PLAC® Test. The new PLAC Test format, based on immunoturbidimetric technology, is an automated immunoassay designed to run on common existing laboratory equipment, including clinical chemistry analyzers from Hitachi, Roche/Hitachi, and Olympus, significantly expanding the number of clinical labs and physician offices that are able to offer the PLAC Test.

According to Patrick Plewman, president and chief executive officer of diaDexus, this new format of the PLAC Test will play a critical role in the company’s ongoing commitment to the early detection of those at increased risk of stroke and heart disease.

The PLAC Test is a simple blood test that measures lipoprotein-associated phospholipase A2 (Lp-PLA2), an enzyme specific to vascular inflammation implicated in the formation of rupture-prone plaque. The PLAC Test is the only blood test cleared by the FDA to aid in assessing risk of both coronary heart disease and ischemic stroke associated with atherosclerosis. This new PLAC Test format is manufactured for diaDexus by Denka Seiken, based in Tokyo, a leading global diagnostics manufacturer.

A substantial body of evidence published in peer-reviewed journals, including more than 25 prospective population-based studies, supports Lp-PLA2 as a cardiovascular risk marker that provides new information, over and above traditional risk factors, to help uncover hidden heart attack and stroke risk.

“Stroke is the third leading cause of death in the United States, and about 700,000 Americans have a stroke each year,” Plewman said. “Of all strokes, 87 percent are ischemic. By automating the PLAC Test, more labs will be able to provide consistent results more quickly and cost-effectively, providing valuable diagnostic information to physicians who can then implement targeted, proven prevention strategies or consider further evaluation.”

Plewman added that research continues to demonstrate that cholesterol tests and traditional risk factors fail to identify many people at risk for stroke and heart attack. According to a recent article in the medical journal The Lancet, while there is a clear link between high cholesterol and heart disease, there is no clear link between high cholesterol and stroke. “Physicians who are concerned about their patients’ stroke risk—patients with a family history of stroke, high blood pressure, diabetes or other risk factors—need to look beyond cholesterol to specific markers for rupture-prone plaque such as Lp-PLA2,” he said. “The PLAC Test can help identify patients who need more aggressive treatment to help prevent heart attacks and ischemic stroke.”

About diaDexus

diaDexus is a privately held company focused on the development and commercialization of novel, patent-protected diagnostic products with high clinical value. In addition to developing and marketing the PLAC Test, diaDexus is developing a pipeline of promising, patentable cancer diagnostic tests, the most advanced of which is being evaluated for use in the early detection of ovarian cancer. For more information, visit www.plactest.com or www.diaDexus.com.


Source: diaDexus

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