SOUTH SAN FRANCISCO, Calif., June 29, 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 it expects to report strong revenue growth for the 2011 second quarter with revenues of $3.8 million, a 45% increase over the comparable 2010 quarter.
diaDexus also said it had filed, ahead of plan, a 510(k) application for FDA clearance of a new automated Lp-PLA2 activity assay. FDA clearance will provide an automated Lp-PLA2 assay capable of running on high throughput clinical chemistry analyzers. Measurement of the activity of the Lp-PLA2 enzyme provides different cardiovascular risk assessment information compared to the currently marketed ELISA mass assay which measures the concentration of the enzyme. A "research-only" version of this activity assay has been used in ongoing Phase 3 trials of GlaxoSmithKline's darapladib, a potential inhibitor of Lp-PLA2.
Finally, diaDexus announced that Patrick Plewman has resigned from his positions of chief executive officer and member of the board of directors. Board member and former VaxGen CEO, James Panek, will serve as Interim CEO. Brian E. Ward, Ph.D., also a member of the Board, will serve as the company's Interim Chief Operating Officer.
Jim Panek commented, "Patrick co-founded diaDexus and led the transformation from research to commercialization of the PLAC Test, the only blood test cleared by the FDA to predict the risk for coronary heart disease and stroke. Patrick leaves at a time of accelerating revenue growth, a second product filed with the FDA and over 2 million cumulative PLAC Tests sold. The company thanks Patrick for his contribution to laying the foundation for continued growth. He will continue to work with the company as a consultant."The company said it will host a live webcast in August, 2011 to provide detailed second quarter financial results and to update investors on both short- and mid-term milestones.