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Diadexus, Inc. Announces Presentation of Results From the PLAC(R) Activity Test Clinical Validation Study


March 24, 2015 - South San Francisco, CA

Diadexus, Inc. (OTCQB: DDXS), a diagnostics company developing and commercializing products that aid in the prediction of cardiac disease risk, today announced results from the PLAC® Test for Lp-PLA2 Activity (PLAC® Activity Test) clinical validation study, presented for the first time today during an oral presentation at the European Atherosclerosis Society 83rd Congress in Glasgow, UK. The results from this study were used in the 510(k) submission for this new test, which was cleared by the U.S. Food and Drug Administration in December 2014 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.

"This is the largest data set in patients without baseline cardiovascular disease to demonstrate an association between elevated Lp-PLA2 Activity levels and the risk of CHD," said Mary Cushman, M.D., MSc of the University of Vermont College of Medicine. "This clinical validation study was conducted with a careful adjudication of events, showing no difference in the risk prediction among subpopulations based on gender, race, or age. This clinical performance of Lp-PLA2 Activity levels is significant for primary prevention, which includes approximately 75% of the population at-risk for CHD events."

An analysis based on a cohort of approximately 4,000 subjects with no prior history of cardiovascular events enrolled in the REasons for Geographic And Racial Differences in Stroke (REGARDS) Study, an NIH-funded longitudinal study, demonstrated that elevated Lp-PLA2 Activity levels are associated with a significant increased risk of CHD events occurring over a 5-year period.

Results showed:

  • The study cohort included 615 subjects with a CHD event and 3,686 subjects who remained free of CHD during a follow-up period of 5.3 years.
  • The unadjusted hazard ratio (HR) of elevated Lp-PLA2 Activity levels for CHD events was 1.60 (95% CI: 1.31-1.97), and 1.46 (95% CI: 1.14, 1.97) after adjustment for age, sex, hypertension, diabetes, smoking, LDL and HDL cholesterol.

"The performance of PLAC Activity in the REGARDS Study cohort builds upon the established body of peer-reviewed literature validating the significance of Lp-PLA2 for prognosticating coronary heart disease risk," said Kenneth C. Fang, M.D., chief medical officer for Diadexus. "The Activity Test demonstrates robust analytical performance and provides actionable, incremental information about future coronary heart disease events for at-risk patients without a prior history."

About the Oral Presentation

Title: "Lipoprotein-associated phospholipase A2 (Lp-PLA2) activity and coronary heart disease risk in a biracial cohort: the REasons for Geographic And Racial Differences in Stroke (REGARDS) cohort"

Lead Author: Mary Cushman, M.D., M.Sc., Professor of Medicine and Pathology, Department of Medicine, University of Vermont

Time: March 24, 2015 at 5:45 pm Greenwich Mean Time (10:45 am Pacific Time)

For further information: http://www.eas2015.kenes.com/

About the PLAC® Test for Lp-PLA2 Activity

The PLAC® Test for Lp-PLA2 Activity, cleared by the U.S. FDA in December 2014, is to be used 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, a population which represents approximately 75% of coronary heart disease patients. Lp-PLA2 (lipoprotein-associated phospholipase A2) is a cardiovascular risk marker supported by a decade of peer-reviewed literature. Lp-PLA2 provides important new information about blood vessel inflammation, over and above the traditional risk factors measured on a lipid panel.

For more information about the test, visit http://placactivity.com/ or the PLAC® Test YouTube Channel.

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 (lipoprotein-associated phospholipase A2), 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 this biomarker's utility. Diadexus' products are the only two FDA-cleared tests to measure Lp-PLA2: The PLAC® Test ELISA Kit first cleared by the FDA in 2003 and The PLAC® Test for Lp-PLA2 Activity cleared in December 2014.

The Company also has a pipeline of biomarkers for heart failure, proADM, proET-1 and proANP, with each providing 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. For more information, please visit the Company's website at www.diadexus.com.

CONTACT:
Amy Figueroa, CFA
650-246-6424
Investor Relations and Corporate Communications
Email Contact

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