IRVINE, Calif., Feb. 22, 2011 /PRNewswire/ -- ResearchDx announced today the official launch of the first-ever Contract Diagnostics Organization or CDO.
Recent FDA initiatives, such as the Critical Path Initiative and the Drug-Diagnostic Co-Development Concept Paper, have spurred biopharmaceutical companies' interest in biomarker research for the purpose of developing companion diagnostics. The traditional Contract Research Organization (CRO), which has focused on clinical trials for pharmaceutical products, cannot meet the need for both an in-depth knowledge of the diagnostics industry and the ability to run diagnostic tests in a clinical laboratory. Conversely, Diagnostics companies lack the ability to perform clinical testing and have an incentive to steer diagnostic development toward their existing products' technology platforms. However, ResearchDx, as a CDO, provides all of these services in an integrated, technology-independent manner that stays focused on their customers' business objectives.
"At ResearchDx, we take contract R&D for diagnostics to the next generation," states co-founder Philip Cotter. "Our partners trust ResearchDx to provide everything they need to develop a diagnostic product, and that we make their business objectives our priority."
Dr. Philip Cotter and Dr. Mat Moore, the founders of ResearchDx, have a passion for the advancement of personalized medicine. With their team's extensive experience in managing clinical laboratories, designing and managing clinical research, and navigating the complex regulatory environment specific to diagnostics, they saw the opportunity to fill an unmet need for partnership with the biopharmaceutical and diagnostics industries. In founding the first-ever CDO, they have achieved their vision to help biopharmaceutical companies overcome the barriers to developing diagnostic products.
ResearchDx is a Contract Diagnostics Organization (CDO) for the biopharmaceutical and diagnostic industries. The company provides integrated, flexible services for the diagnostic development process – from initial assay concepts and discovery through clinical research to regulatory approval. ResearchDx's service areas include clinical research, clinical laboratory services, diagnostic manufacturing, and consulting.
CONTACT: Philip Cotter, +1-510-332-0477, for ResearchDx