diaDexus (DDXS.OB) is a medical diagnostics company, located in South San Francisco, California, focused on the development and commercialization of patent-protected in vitro diagnostic products addressing significant unmet needs in cardiovascular disease.
diaDexus’ first product, the PLAC® Test helps identify individuals at increased risk of suffering a heart attack or stroke, the #1 and #3 causes of death respectively in the U.S. These events can be prevented through early detection and more aggressive risk-reducing strategies.
The PLAC Test measures Lp-PLA2, a vascular-specific inflammatory marker implicated in the formation of rupture-prone plaque, and is the only blood test cleared by the FDA to assess risk for coronary heart disease and ischemic stroke associated with atherosclerosis. There are more than 30 published prospective studies validating Lp-PLA2 as a novel and valuable cardiovascular risk marker that can help improve early risk assessment.
GlaxoSmithKline (GSK) has developed an Lp-PLA2 inhibitor (darapladib) and is currently testing the drug in two large, global, Phase III clinical trials involving over 27,000 patients to determine if inhibition of the enzyme reduces cardiovascular events.
diaDexus was formed in 1997 as a joint venture between SmithKline Beecham (now GSK) and Incyte. GSK granted diaDexus an exclusive license to certain diagnostic intellectual property, including Lp-PLA2.
The PLAC Test was first cleared by the FDA as an aid in the assessment of risk for coronary heart disease in 2003 and in 2005 received additional clearance as an aid in the assessment of risk for ischemic stroke associated with atherosclerosis.
In 2007 the PLAC Test was granted a Category I CPT Code (83698) by the American Medical Association and is reimbursed by the Centers for Medicare and Medicaid Services (CMS) with a National Limitation Amount (NLA) of $48.08 in the 2012 CMS Clinical Laboratory Fee Schedule.
In July 2010, diaDexus completed a reverse merger with VaxGen. diaDexus currently trades on the OTC Bulletin Board (DDXS.OB). diaDexus' revenue in 2010 was $11.7 million (unaudited). The company will begin 2011 with $20.4 million (unaudited) in cash and no debt.