[December 15, 2014]

diaDexus, Inc. Receives FDA Clearance for PLAC Activity Test to Assess Coronary Heart Disease Risk

diaDexus, Inc. (OTCQB:DDXS), a company developing and commercializing proprietary cardiovascular diagnostic products, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its PLAC^® Test for Lp-PLA₂ Activity. This new test is an enzyme assay for the quantitative determination of Lp-PLA₂ (Lipoprotein-Associated Phospholipase A₂) activity in human plasma and serum. An analysis based on REGARDS, a U.S.-based National Institutes of Health (NIH)-funded longitudinal study, using a cohort of approximately 4,500 individuals with no prior history of cardiovascular events, demonstrated that elevated Lp-PLA₂ Activity levels are associated with a significant increase for risk of coronary heart disease.

"The FDA's clearance of our second test is an important step in achieving our vision of evolving from a single-product business into a multi-product company," said Lori Rafield, Ph.D., interim executive chair and chairman of the board for diaDexus. "Our PLAC tests, ELISA and now Activity, are the only FDA-cleared Lp-PLA₂ tests to help identify the hidden risk of coronary heart disease, which includes heart attack. This new PLAC Activity test has demonstrated robust analytical performance and can be used broadly by moderate-complexity reference labs, hospital labs, and physician office labs using a wide range of typical clinical chemistry analyzers, allowing us to meaningfully expand our customer base."

The first indication for the new test is for use in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk of coronary heart disease (CHD) in patients with no prior history of cardiovascular events, which is approximately 75% of this population. According to the 2013 ACC/AHA Guideline on the Assessment of Cardiovascular Risk, more than 16 million Americans are at moderate risk for a first atherosclerotic cardiovascular disease event over the next ten years.

To commercialize this new test, diaDexus will use its established salesforce. Beginning in the first quarter of 2015, the company expects to start contracting and enabling new lab customers. Utilizing an established salesforce and a multi-faceted education-based strategy, diaDexus expects to begin providing laboratory customers and physicians appropriate information on the benefits of using PLAC testing for patient risk assessment. Evidence supporting the clinical utility of PLAC Activity was based on data from the Reasons for Geographic and Racial Differences in Stroke (REGARDS) study as well as the substantial peer-reviewed literature supporting Lp-PLA₂ as an important cardiovascular risk marker Demand is expected to be generated as physicians become familiar with and begin to order the test from diaDexus' lab customers.

About Cardiovascular Disease

Cardiovascular disease (CVD), which results in heart attacks, strokes and other cardiovascular events, represents the number one cause of death and disability in the United States. As many as 85 million Americans have an elevated risk of CVD, and in total, cardiovascular-related events cost the U.S. healthcare system an estimated $400 billion each year. Although it is common knowledge that high cholesterol is a significant risk factor for CVD, cholesterol testing alone is often not enough to identify patient at risk for CVD. Fifty percent of hearts attacks occur in patients with normal cholesterol levels, with the majority of heart attacks and ischemic strokes caused by plaque rupture, in which vascular inflammation plays a key role. For thirty percent of patients, sudden cardiac death is the first symptom of heart disease.

About Lp-PLA₂

Lipoprotein-Associated Phospholipase A₂ (Lp-PLA₂) is a vascular-specific inflammatory marker that is critical in the formation of rupture-prone plaque. When elevated, this enzyme indicates arterial inflammation, which is associated with increased risk for heart attack and stroke. The higher the level of Lp-PLA₂, the higher the risk of a cardiovascular event, even when LDL is normal.

About the PLAC^® Tests

The PLAC Tests are simple blood tests that measure Lp-PLA₂ levels in a patient's blood. diaDexus has developed and commercialized two FDA-cleared PLAC Tests. The PLAC Test ELISA Kit is an aid in predicting risk for CHD and ischemic stroke associated with atherosclerosis and is commercially available in the United States. The PLAC Test for Lp-PLA₂ Activity is to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk of CHD in patients with no prior history of cardiovascular events, which represents approximately 75% of coronary heart disease patients. Both tests are covered under the established CPT reimbursement code for Lp-PLA₂ testing.

About diaDexus, Inc.

diaDexus, Inc., based in South San Francisco, California, develops and commercializes proprietary cardiovascular diagnostic products addressing unmet needs in cardiovascular disease. The company has two FDA-cleared diagnostic products to uncover the hidden risk of cardiovascular disease. The PLAC^® Test ELISA Kit is the only blood test cleared by the FDA to aid in predicting risk for both coronary heart disease and ischemic stroke associated with atherosclerosis, the #1 and #3 causes of death, respectively, in the United States. The PLAC^® Test for Lp-PLA₂ Activity is to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk of coronary heart disease in patients with no prior history of cardiovascular events, which represents approximately 75% of coronary heart disease patients. The company also has heart failure biomarkers for future development. For more information, please visit the company's website at www.diaDexus.com.

Forward-Looking Statements

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are subject to various risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. Important factors include acceptance of our PLAC^® Test products in the marketplace; our ability to demonstrate that treatment of individuals based on their Lp-PLA₂ levels improves clinical outcomes in prospective clinical studies; size of the market, product pricing and potential demand; the continued focus of regulatory agencies and payors on costs and our laboratory customer practices for our concentrated customer base; third party payors' acceptance of and reimbursement for the PLAC^® Tests; our ability to develop and commercialize new products and services; our limited revenue and cash resources; and our ability to successfully transition to new management leadership. Additional factors that could cause our results to differ materially from those described in the forward-looking statements can be found in our most recent quarterly report on Form 10-Q and other reports filed with the Securities and Exchange Commission, and available at the SEC's (News - Alert) web site at www.sec.gov. The information in this release speaks only as of the date hereof, and except as required by law, we disclaim any obligation to update or revise any forward looking statement.

[ Back To TMCnet.com's Homepage ]