SOUTH SAN FRANCISCO, Calif., Oct. 6, 2011 /PRNewswire/ -- diaDexus, Inc. (OTC Bulletin Board: DDXS), a diagnostics company focused on the development and commercialization of patent-protected in vitro diagnostic products addressing unmet needs in cardiovascular disease, today announced that the company has received its Certificate of Registration of Quality Management System to I. S. EN ISO 13485:2003. The achievement marks successful completion of an independent evaluation by The National Standards Authority of Ireland. The ISO certification indicates that diaDexus has been assessed and deemed to comply with the requirements of the ISO standard with respect to the design, manufacture and distribution of in vitro diagnostic reagents for the determination and evaluation of cardiovascular biomarkers. The certification guarantees that all processes at diaDexus are fully controlled and documented and compliant with the company’s Quality Management System.
“The ISO certification is a significant accomplishment and an important milestone for diaDexus. Certification affirms that our Quality System meets the highest standards and strengthens diaDexus’ commitment to product quality and customer service. It also positions the company for further expansion into the international market place,” said Brian E. Ward, Ph.D., Chief Executive Officer.
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-PLA2 is the only blood test cleared by the FDA to aid in assessing risk for both coronary heart disease and ischemic stroke associated with atherosclerosis. For more information, please visit the company’s website at www.diaDexus.com.
Forward-Looking Statements
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 operations and products and other statements that are not historical in nature, particularly those that use terminology such as “will,” “potential”, “could,” “can,” “believes,” “intends,” “continue,” “plans,” “expects,” “projects,” “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 new automated Lp-PLA2 activity assay and any new diagnostic products; its ability to hire and retain a chief executive officer and chief financial officer, and to attract, retain and motivate other qualified personnel; its relationship with key customers; diaDexus’ reliance on sole source third party manufacturers to manufacture and supply our 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-PLA2 levels improves clinical outcomes in prospective clinical studies; the rate of adoption of the PLAC Test by doctors and laboratories; third party payor’s acceptance of and reimbursement for the PLAC Test; diaDexus’ limited revenue and cash resources; the adequacy of the company’s intellectual property rights; and diaDexus’ significant corporate expenses, including expenses associated with being a public company and real estate liabilities. 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, subsequent quarterly reports on Form 10-Q, and other reports filed with the Securities and Exchange Commission, which are 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.
