SOURCE: diaDexus, Inc.

Diadexus, Inc.

November 10, 2015 09:00 ET

Diadexus, Inc. Presents New PLAC® Activity Data From the REGARDS Study at 2015 American Heart Association Scientific Sessions

Study Demonstrates the Added Clinical Performance of the PLAC® Activity Test for Lipoprotein-Associated Phospholipase A2 (Lp-PLA2) to the Framingham Risk Score

SOUTH SAN FRANCISCO, CA--(Marketwired - Nov 10, 2015) - Diadexus, Inc. (OTCQB: DDXS), a diagnostics company developing and commercializing products that aid in the prediction of cardiac disease risk, today announced a poster presentation at the 2015 American Heart Association (AHA) Scientific Sessions taking place November 7-11, 2015 in Orlando, FL.

"Extensive data have already shown that Lp-PLA2 activity levels are associated with increased risk of coronary heart disease (CHD), but an important, unanswered question has been whether that association is consistent across different demographic and patient risk groups," said Mary Cushman, M.D., M.Sc., Professor of Medicine and Medical Director, Thrombosis/Hemostasis Program, University of Vermont College of Medicine. "This refined analysis of the REGARDS Study data substantiates the association of Lp-PLA2 with CHD risk, irrespective of both gender and age above or below 65 years for both blacks and whites. In addition, the Lp-PLA2 activity result demonstrated a consistent association with CHD for all patient risk subgroups defined by the Framingham Risk Score, a commonly used clinical assessment tool for CHD risk."

"These data substantiate the clinical performance of the PLAC® Activity test in these at-risk patient subgroups, and importantly, identify it as clinical tool that provides information that is independent and incremental to the Framingham Risk Score," said Kenneth C. Fang M.D., Chief Medical Officer of Diadexus. "In particular, the performance metric of a net reclassification improvement (NRI) of 13% shows the added clinical value that the PLAC Activity Test provides for the approximately 75% of at-risk patients with no prior history of cardiovascular events, as shown in the REGARDS Study."

Diadexus, and its collaborators, are presenting these data in support of the Company's recently launched PLAC® Activity test for Lp-PLA2 activity, which was cleared by the FDA in December of 2014.

A summary of the data presented at AHA is below:

Poster Title: Robust Performance of LpPLA2 Activity in Predicting Cardiovascular Disease Risk in a National, Diverse, Sample
Date & Time: Tuesday, November 10, 2015, from 2:00-3:15 pm ET
Location: Poster Hall, A2, PS
Poster #: T 2131
Session ID: APS.91.04 - Epidemiology and Population Studies IV: Lipids and Cardiovascular Disease Risk

Summary: Approximately 75% of cardiovascular disease (CVD) patients have no prior history of cardiovascular events. There is evidence linking elevated LpPLA2 levels with heart disease, suggesting that the early identification of patients with elevated LpPLA2 levels has the potential to transform primary care paradigms in the area of cardiovascular health.

This poster presents data from a case cohort study within the larger REGARDS study. The study includes a random cohort sample of 3,719 patients derived from the 23,019 REGARDS participants who were free from stroke and CVD at baseline in 2003-2007. The purpose of the study was to assess the association between LpPLA2 activity, as measured using Diadexus' proprietary LpPLA2 activity (PLAC® Activity) test, and risk of CVD. Acute CHD during complete follow-up through December 31, 2010 was adjudicated by an expert committee and defined as definite or probable myocardial infarction (MI) not resulting in death within 28 days, or fatal acute CHD.

LpPLA2 activity was dichotomized at the 80th percentile of gender-specific activity: 250 nmol/ml/min for men and 200 nmol/ml/min for women. 565 cases of acute CHD were available for analysis. After controlling for race, age, sex, statin use, income, education, lipid profile, hypertension, diabetes, and history of smoking, elevated LpPLA2 activity was associated with increased risk of CVD (HR=1.52; 95% CI [1.21, 1.91]). The increased risk was consistent across all demographic and risk categories, and was observed even in participants deemed to have a low risk of CVD as defined by the Framingham Risk Function.

A copy of the poster presentation is available here.

About the REGARDS Study

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.

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 provides 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 within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements related to our revenue growth expectations and guidance, success of our business model and strategy, timing of regulatory submission and clinical and commercial need for our PLAC and ELISA tests. 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 actual results to differ materially from those expressed in such forward-looking statements include whether the evidence linking elevated LpPLA2 levels with heart disease has the potential to impact cardiovascular health treatment, including use of our products; the factors necessary to achieve our revenue guidance; sales of our PLAC® Test products in the marketplace; our ability to grow revenues from existing and new customers, including hospitals, clinics and physician labs; product pricing and demand with a concentrated customer base; the continued focus of regulatory agencies and payors on costs and our laboratory customer practices; relationships with key customers; our ability to continue to build our heart failure franchise; our ability to identify and build products with additional biomarkers; third party payors' acceptance of and reimbursement for the PLAC® Tests; our ability to continue to manufacture the PLAC® Tests to meet customer demand; the potential for success of and timing of when our development efforts may be completed; the adequacy of our intellectual property rights and our ability to maintain a proprietary position for our lead product; our limited revenue and cash resources; our significant corporate expenses, including real estate lease liabilities and expenses associated with being a public company; our ability to develop proADM for regulatory submission, and our ability to successfully integrate our 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 web site at www.sec.gov. The information set forth herein speaks only as of the date hereof, and except as required by law, we disclaim any intention and does not assume any obligation to update or revise any forward looking statement, whether as a result of new information, future events or otherwise.

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