diaDexus Launches PLAC(R) Test for Lp-PLA(2) Activity in Europe
Published: Mar 05, 2012
SOUTH SAN FRANCISCO, March 5, 2012 /PRNewswire/ -- diaDexus, Inc. (OTC Bulletin Board: DDXS), a company focused on the development and commercialization of proprietary cardiovascular diagnostic products, today announced the commercial launch of its CE-marked PLAC® Test for Lp-PLA(2) Activity in Europe. The PLAC Activity test will be sold in Europe to clinical and hospital laboratories through a network of 11 distributors. The PLAC Test for Lp-PLA(2) Activity is an easy-to-perform blood test designed to be used in conjunction with clinical evaluation and patient risk assessment as an indicator of atherosclerotic cardiovascular disease. The new PLAC Test for Lp-PLA(2) Activity will be used by healthcare professionals to identify the hidden risk of cardiovascular events that are missed by traditional risk factors, such as cholesterol levels, blood pressure, family history and smoking. Physicians in Europe may request the PLAC Test for Lp-PLA(2) Activity for patients with two or more cardiovascular risk factors.
A meta-analysis published in 2010 in The Lancet by the Lp-PLA(2)Studies Collaboration that included data from approximately 58,000 patients from 18 previously published studies confirmed that Lp-PLA(2) levels are significantly related to cardiovascular disease risk. Cardiovascular heart disease is the first cause of mortality in Europe resulting in 4.3 million deaths each year. In 2011, diaDexus initiated a comprehensive outreach and physician education program, including scientific and clinical presentations at both the European Stroke Association and the European Society for Cardiology meetings. The outreach efforts have highlighted that circulating levels of the enzyme are associated with increased risk of atherosclerotic cardiovascular disease, and now it will be possible for Lp-PLA(2) testing to be more widely available throughout Europe.
"We will continue collaborating with key opinion leaders in each European country to work toward publication of medical practice guidelines to support Lp-PLA(2) assessment as part of both regular annual medical checkups as well as certain hospital-based cardiovascular assessment programs," said Brian E. Ward, Chief Executive Officer. "While we expect a modest contribution to 2012 revenue from European sales, we expect greater contributions to revenue as awareness increases and reimbursement coverage is secured in key European countries, such as Germany, France and the United Kingdom."
About the new PLAC Activity test
The PLAC Test for Lp-PLA(2) Activity measures the enzymatic activity of Lp-PLA(2), a vascular specific inflammatory enzyme that is produced in rupture prone plaques. The PLAC Test for Lp-PLA(2) Activity can be performed on easy-to-use clinical chemistry analyzers that are found in clinical and hospital laboratories. In addition, the PLAC Test for Lp-PLA(2) Activity specimen collection and preparation are not difficult, making the PLAC Test for Lp-PLA(2) Activity easy to prescribe and perform.
About diaDexus, Inc.
diaDexus, Inc., based in South San Francisco, California, is focused on the development and commercialization of patent-protected in vitro diagnostic products addressing unmet needs in cardiovascular disease. The company's PLAC ELISA test for Lp-PLA(2) 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 company's PLAC Test for Lp-PLA(2) Activity, a CE-marked test, is an indicator of atherosclerotic cardiovascular disease, the #1 cause of death in Europe. diaDexus is ISO 13485 certified and is manufacturing the PLAC Test for Lp-PLA(2) Activity on-site. For more information, please visit the company's website at www.diaDexus.com.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the company's plans, objectives, expectations and intentions with respect to future operations and products and other statements that are not historical in nature, particularly those that use terminology such as "will," "potential", "could," "can," "believe," "intends," "continue," "plans," "expects," "estimates" or comparable terminology. Forward-looking statements are based on current expectations and assumptions, and entail various known and unknown risks and uncertainties that could cause actual results to differ materially from those expressed in such forward-looking statements. Important factors known to diaDexus that could cause actual results to differ materially from those expressed in such forward-looking statements include diaDexus' ability to maintain regulatory clearance for and successfully commercialize its PLAC test, including its ability to submit a new 510(k) application for, and obtain FDA clearance of, its new automated Lp-PLA(2) activity test; diaDexus' ability to successfully launch and commercialize the PLAC activity test in Europe; diaDexus' ability to attract, retain and motivate qualified personnel; diaDexus' relationship with key customers, including GlaxoSmithKline ("GSK"), the licensor of Lp-PLA(2); diaDexus' ability to perform under its license from GSK for diagnostic use of Lp-PLA(2); diaDexus' reliance on sole source third party manufacturers to manufacture and supply diaDexus' main reagent and the PLAC Test; the effects of government regulations and the company's ability to comply with such regulations; diaDexus' ability to demonstrate that treatment of individuals based on their Lp-PLA(2) levels improves clinical outcomes in prospective clinical studies; the rate of adoption of the PLAC Test by doctors and laboratories; third party payors' acceptance of and reimbursement for the PLAC Test; downward pressure on diaDexus' product pricing, particularly from the company's largest customers; the adequacy of the company's intellectual property rights; diaDexus' limited revenue and cash resources; and diaDexus' significant corporate expenses, including real estate liabilities and expenses associated with being a public company. Additional factors that could cause diaDexus' results to differ materially from those described in the forward-looking statements can be found in diaDexus' most recent annual report on Form 10-K and subsequent quarterly reports 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 diaDexus disclaims 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.
SOURCE diaDexus, Inc.