It provides all services needed for product development, from discovery to negotiating regulatory pathways.
A new contract diagnostics organization (CDO), ResearchDx, has been established to provide integrated, flexible services for the development of diagnostics. Irvine, California-based ResearchDx claims to be the first dedicated CDO, and will offer an integrated portfolio of services from initial assay concepts and discovery through to clinical research, manufacturing, and regulatory approval.
The firm says a specialized CDO can provide the expertise for diagnostics development that can’t be met by CROs or diagnostics companies. It claims traditional CROs have neither the in-depth knowledge of the diagnostics industry nor the ability to run diagnostic tests in a clinical laboratory. Moreover, the firm adds that diagnostic companies don’t have the ability to carry out clinical testing and will understandably tend to focus on the development of products for their own product platforms. In contrast, ResearchDx says it will offer all the necessary discovery, development, and regulatory services tailored to each client’s projects and requirements.