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New Clinical Endocrinology Guidelines support Lp-PLA2 measurement for risk assessment of coronary artery disease
SOUTH SAN FRANCISCO, Calif., April 26, 2012 -- diaDexus, Inc., a company focused on the development and commercialization of proprietary cardiovascular diagnostic products, today announced the inclusion of its vascular-specific inflammatory marker Lp-PLA2 in the American Association of Clinical Endocrinologists ("AACE") medical guidelines for clinical practice published in the March/April 2012 issue of Endocrine Practice.
"The AACE's guidelines are an important endorsement of the clinical utility of Lp-PLA2 measurement. Specifically, the guidelines recommend the use of multiple markers, including Lp-PLA2, to assist physicians in personalizing therapy for elevations or other abnormalities in blood lipids. These abnormalities, commonly referred to as "dyslipidemia," are a major risk factor for coronary artery disease," said Brian E. Ward, Ph.D., Chief Executive Officer of diaDexus. "As more health care professionals utilize Lp-PLA2 as a component of cardiovascular risk assessment, we believe that diaDexus' PLAC Test for Lp-PLA2 should contribute to saving lives."
The AACE is the third major association of medical professionals to underscore the value of Lp-PLA2. The new recommendations complement medical guidelines published by the American College of Cardiology Foundation/America Heart Association and the American Stroke Association, in 2010 and 2011. These two earlier guidelines support Lp-PLA2 measurement for assessment of cardiovascular risk in asymptomatic adults and for primary prevention of stroke.
The new AACE guidelines(1) recommend Lp-PLA2 measurement as part of global risk assessment for patients with dyslipidemia, and have identified elevated Lp-PLA2 levels as an important risk factor for the development of vascular disease. Dyslipidemia is a major risk factor for the development of coronary artery disease ("CAD") and may even be a prerequisite for CAD, occurring before other major risk factors come into play. Elevated Lp-PLA2 levels are specific for inflammation in the blood vessels, and are not influenced by obesity, infections or other inflammatory conditions unrelated to atherosclerosis.
The AACE guidelines include the following statements:
- Lp-PLA2 has been identified as a strong and independent predictor of cardiovascular disease events and stroke in patients with and without clinically evident CAD.
- Measurement of Lp-PLA2, in some studies, has demonstrated more specificity than high sensitivity C-Reactive Protein ("hs-CRP") when it is necessary to further stratify a patient's cardiovascular disease risk, especially with elevated hs-CRP in the presence of other causes of inflammation (hs-CRP is an indiscriminate marker of general inflammation).
- Significantly elevated Lp-LPA2 in combination with significantly elevated hs-CRP constitutes very high cardiovascular disease risk in individuals with low or moderately elevated LDL cholesterol.
(1) American Association of Clinical Endocrinologists' Guidelines for Management of Dyslipidemia and Prevention of Atherosclerosis. PS Jellinger et al. Endocrine Practice Vol 18 (Suppl 1) March/April 2012.
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® 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 company's PLAC® Test for Lp-PLA2 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-PLA2 Activity on-site. For more information, please visit the company's website at www.diaDexus.com (You will be visiting a website outside of PCRonline, we are not responsible for its contents).
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 submit a new 510(k) application for, and obtain FDA clearance of, its new automated Lp-PLA2 Activity test; diaDexus' ability to gain acceptance of its PLAC® Test products in the marketplace, including its ability to demonstrate that treatment of individuals based on their Lp-PLA2 levels improves clinical outcomes in prospective clinical studies; diaDexus' high degree of customer concentration, including the downward pressure that its largest customers may be able to exert on its product pricing; diaDexus' relationship with key customers, including GlaxoSmithKline, the licensor of Lp-PLA2; diaDexus' reliance on a sole source third party manufacturer to manufacture and supply diaDexus' PLAC® ELISA Test Kit; third party payors' acceptance of and reimbursement for the PLAC® Tests; diaDexus' ability to develop and commercialize new products and services; various risks associated with the international expansion of diaDexus' business; diaDexus' ability to successfully launch and commercialize the PLAC® Test for Lp-PLA2 Activity in Europe, and its dependence on its distributors for foreign sales of that test; diaDexus' ability to initiate and continue to manufacture the PLAC® Test for Lp-PLA2 Activity at its facility in South San Francisco, California; the adequacy of diaDexus' intellectual property rights; diaDexus' ability to satisfy its obligations under its license agreements, to maintain its license rights under those license agreements and to enter into any necessary licenses on acceptable terms; diaDexus' ability to attract, retain and motivate qualified personnel; the effects of U.S. and foreign government regulations and diaDexus' ability to comply with such regulations; diaDexus' limited revenue and cash resources; and diaDexus' significant corporate expenses, including real estate lease 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.