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New Billing Code and Medicare Payment Recommendation Issued for Lp-PLA2 Testing.

diaDexus' PLAC([R]) Test Measures Lp-PLA2, a Novel Heart Disease and Stroke Risk Factor

SOUTH SAN FRANCISCO, Calif. -- diaDexus, Inc., today announced that the American Medical Association has issued a unique Category I Current Procedural Terminology (CPT([R])) code for the measurement of lipoprotein-associated phospholipase A2 (Lp-PLA2), a cardiovascular-specific inflammatory enzyme found in unstable, rupture-prone plaque. Plaque rupture is the leading cause of heart attack and stroke. diaDexus makes the PLAC test, the only Food and Drug Administration-approved blood test for the measurement of Lp-PLA2.

The new analyte-specific codeCo83698Cohas been issued under the Pathology and Laboratory (chemistry) section of the coding schedule. In conjunction with the new code, the Centers for Medicare & Medicaid Services published its 2007 Clinical Laboratory Fee Schedule, recommending a payment of $47.43 for Lp-PLA2 testing. The new CPT code and payment recommendation will be effective Jan. 1, 2007.

The PLAC test is a simple blood test that aids in predicting risk for coronary heart disease and ischemic stroke associated with atherosclerosis.

"The unique CPT code and corresponding payment guideline are critical milestones for the PLAC test," said Patrick Plewman, president and chief executive officer of diaDexus. "The American Medical Association's recognition of the need for an analyte-specific code for Lp-PLA2 underscores the medical necessity of a diagnostic test in identifying risk earlier to prompt initiation of aggressive treatment that can prevent cardiovascular events. We look forward to working with physicians, clinical labs, and health plans across the country to foster positive coverage, streamline billing, and increase access to this clinically valuable test."

Lp-PLA2 is an enzyme that associates in the blood primarily with low-density lipoprotein (LDL, the "bad" cholesterol). Lp-PLA2 is carried to the walls of coronary arteries by LDL, where the enzyme can activate an inflammatory response, promoting atherosclerosis. As a result, Lp-PLA2 serves as a specific indicator of vascular inflammation. Individuals identified as being at high risk for coronary heart disease or stroke based on elevated Lp-PLA2 levels are candidates for proactive preventive measures, such as lifestyle modification and therapeutic intervention.

About diaDexus

diaDexus, Inc., a privately held biotechnology company based in South San Francisco, is focused on the discovery, development, and commercialization of clinically valuable, patent-protected diagnostic products. In addition to the PLAC test, diaDexus is developing a pipeline of novel cancer diagnostic tests. For more information, visit www.plactest.com or www.diaDexus.com.
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Publication:Business Wire
Date:Dec 7, 2006
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