diaDexus, Inc. (OTCQB:DDXS), a company developing and commercializing proprietary cardiovascular diagnostic products, today announced an exclusive licensing and supply agreement with Thermo Fisher Scientific Inc., the world leader in serving science with $17 billion in revenues, that will provide diaDexus with the ability to develop and commercialize three independent biomarkers (MR-proADM (midregional pro adrenomedullin), MR-proANP (midregional pro atrial natriuretic peptide), and CT-proET1 (C-terminal pro endothelin-1)) to aid in risk prediction and prognosis for heart failure.
"This licensing agreement significantly expands our pipeline of cardiovascular tests and allows us to utilize the market channel infrastructure we have built for our PLAC® tests by providing our cardiovascular specialty laboratory partners and their physician customers the opportunity to address additional hidden risks for cardiovascular disease," said Brian Ward, Ph.D., diaDexus' president and chief executive officer. "Primary care physicians have told us that they need additional tools to better deliver individualized care to their patients emphasizing the need to identify patients at risk for heart failure years before they may begin to suffer from significant disease. To address this need, we plan to develop three individual diagnostic tests, one per biomarker, which will address different stages of heart failure from prediction, diagnosis and survival. We estimate that the addressable U.S. market for these tests is similar to that of our PLAC test."
Under the terms of the agreement, diaDexus will have exclusive rights to develop and commercialize diagnostic clinical laboratory tests based on these biomarkers in the United States. diaDexus plans to conduct the necessary clinical studies needed to allow for regulatory submission and potential U.S. Food and Drug Administration (FDA) clearance for these tests in the future.
“There is a large unmet clinical need for biomarkers that can identify patients along the spectrum of heart failure progression from disease risk in apparently healthy individuals, to symptomatic heart failure,” said Alan Maisel, MD, professor of Medicine at the University of California, San Diego. “Improved tools for the diagnosis and management of heart failure reduce the risk of administering unnecessary and potentially harmful therapies, and allows for individualization of treatment programs in a disease which is very diverse with respect to diagnosis and disease progression.”