diaDexus, Inc. (OTCQB:DDXS), a company developing and commercializing proprietary cardiovascular diagnostic products, today announced that it is advancing its clinical program to support the submission of the company’s PLAC® Test for Lp-PLA 2 Activity. This important next step in the regulatory clearance process follows a recent pre-submission meeting with the U.S. Food and Drug Administration (FDA).
diaDexus has partnered with a large longitudinal cardiovascular disease study to validate the PLAC Test for Lp-PLA 2 Activity. It is anticipated that the clinical study sample analysis will be initiated prior to the end of the first quarter of 2014.
“We now have further clarity on our path forward to potential FDA clearance in the United States, and we are pleased to be partnered with a group of committed physician-investigators in this effort,” said Brian Ward, Ph.D., diaDexus’ president and chief executive officer. “The PLAC Test for Lp-PLA 2 Activity is already on the market in Europe where customers value the substantial benefits of improved productivity due to automation and far simpler sample handling. Our goal is to achieve FDA clearance to be able to offer these same product benefits to our U.S. customers.”
The company’s PLAC Tests are simple blood tests that uncover the hidden risk of heart attack by measuring Lp-PLA 2, a vascular-specific inflammatory marker critical in the formation of rupture-prone plaque. Lp-PLA 2 levels aid in cardiovascular disease risk assessment independent from other biomarkers—providing distinct insight into the relationship among inflammation, atherosclerosis and cardiovascular outcomes. The PLAC Tests support preventive medicine by providing physicians with a way to uncover the risk of heart attack beyond standard lipid measurements, such as cholesterol testing.About diaDexus, Inc. diaDexus, Inc., based in South San Francisco, California, develops and commercializes proprietary cardiovascular 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-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. Forward-Looking Statements This release contains forward-looking statements 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 diaDexus that could cause actual results to differ materially from those expressed in such forward-looking statements include whether the PLAC Test for Lp-PLA 2 Activity can achieve FDA clearance and if even if cleared, the ability to gain acceptance in the marketplace; and the timing of data from the partnered longitudinal cardiovascular disease study. 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 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, 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.