SOURCE: diaDexus, Inc.

Diadexus, Inc.

May 23, 2016 09:00 ET

Diadexus, Inc. and Sonic Healthcare USA Sign National Agreement for PLAC® Activity Test

Partnering With Fifth Largest U.S. Laboratory Service Provider to Launch Broadly the PLAC® Activity Test, an FDA-Cleared Test for Coronary Heart Disease Risk Assessment

SOUTH SAN FRANCISCO, CA--(Marketwired - May 23, 2016) - Diadexus, Inc. (OTCQB: DDXS), a diagnostics company developing and commercializing products that aid in assessing the prognosis of cardiac disease, today announced it has signed an agreement with Sonic Healthcare USA to launch the company's PLAC® Activity Test into Sonic's national network of laboratories. Sonic Healthcare USA is the fifth largest provider of laboratory services in the United States and is part of Sonic Healthcare, the world's third largest international laboratory service provider. The PLAC® Test for Lp-PLA2 Activity is the only FDA-cleared test used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting the risk of coronary heart disease (CHD) in patients with no prior history of cardiovascular events, a population representing approximately 75% of CHD patients.

"Sonic is the first laboratory to offer the PLAC® Activity Test nationally with commercial activities in multiple states and an extensive network of 14 laboratories, over 250 customer collection sites, and approximately 100 sales representatives. They are also part of a leading worldwide provider of laboratory services, which could expand access to this new test internationally in the future," said Lori Rafield, Ph.D., Chairman and Chief Executive Officer for Diadexus. "Our experienced sales and marketing team is already working with Sonic's commercial team, and validation has been completed. We are both committed to a successful and expedited product launch to make the PLAC® Activity Test available broadly to healthcare providers and conveniently to patients through customer collection sites nationally. Healthcare providers want tests supported by extensive clinical data and FDA clearance to help inform decisions in managing patients under their care, and the clinical utility of the PLAC® Activity Test as an independent marker to predict CHD risk is supported by extensive published research. We look forward to working collaboratively with Sonic to grow the market significantly by educating healthcare providers and raising the awareness of this valuable new tool for managing patients at risk for this disease."

About the PLAC® Test for Lp-PLA2 Activity

The PLAC® Test for Lp-PLA2 Activity, cleared by the U.S. Food and Drug Administration (FDA), is to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting the risk of coronary heart disease (CHD) in patients with no prior history of cardiovascular events, a population which represents approximately 75% of CHD patients. Lp-PLA2 (lipoprotein-associated phospholipase A2) is a cardiovascular risk marker supported by a decade of peer-reviewed literature, and provides important new information about CHD risk, over and above the traditional risk factors measured on a lipid panel.

For more information about the test, visit www.placactivity.com.

About Diadexus, Inc.

Diadexus, based in South San Francisco, California, is a diagnostics company developing and commercializing products that aid in the prediction of cardiac disease risk, providing healthcare providers with actionable information for managing patients. The Company pioneered the testing of Lp-PLA2, a marker of vascular-specific inflammation that provides new information, over and above traditional risk factors measured in a lipid panel, and has over a decade of peer-reviewed literature validating its utility. Diadexus' products, the PLAC® Test ELISA Kit, first cleared by the FDA in 2003, and the PLAC® Test for Lp-PLA2 Activity, cleared in December 2014, are the only two FDA-cleared tests to measure Lp-PLA2.

The Company also has a pipeline of biomarkers for heart failure, proADM, proET-1 and proANP, each of which provide distinct, additive information for healthcare providers over currently available markers. Diadexus also provides services to pharmaceutical partners to address the need to incorporate biomarkers in clinical development. To learn more about the PLAC® Tests, please visit www.plactest.com, or visit the Company's website at www.diadexus.com.

Forward-Looking Statements

This release contains forward-looking statements that are subject to a number of risks and uncertainties, including, but not limited to, statements related to our potential for our PLAC® Activity Test and success of our agreement with Sonic. Forward-looking statements are based on current expectations and assumptions and entail various risks and uncertainties that could cause actual results to differ materially from those expressed in such forward-looking statements. Important factors known to us that could cause our results to differ materially from those described in the forward-looking statements can be found in our recent quarterly report on Form 10-Q, annual report on Form 10-K, and other reports filed with the Securities and Exchange Commission that are available at the SEC's web site at www.sec.gov. Except as required by law, we disclaim any obligation to update or revise any forward looking statement, whether as a result of new information or otherwise.

Contact Information

  • Contact:
    Diadexus, Inc.
    Leone Patterson
    Chief Financial Officer
    (650) 246-6400
    Email Contact