ResearchDx, a new company based in Irvine, Calif., has launched on a platform of bridging gaps between biopharmaceutical and diagnostic R&D to address the shift toward personalized, or stratified, medicine, PharmaTimes has reported.
Billing itself as the “first ever” contract diagnostics organization (CDO), ResearchDx is targeting both biopharmaceutical and diagnostics companies with “integrated, flexible” services for the diagnostic development process, from initial assay concepts and discovery through to clinical research and regulatory approval.
With experience in managing clinical laboratories, designing and managing clinical research, and navigating the complex regulatory environment for diagnostics, ResearchDx said it saw an opportunity to fill an unmet need for partnership with both industries. It cited recent FDA initiatives such as the Critical Path program and the Drug-Diagnostic Co-Development Concept Paper as spurring biopharmaceutical company interest in biomarker research for the purpose of developing companion diagnostics.
Traditional CROs, with their focus on clinical trials for pharmaceutical products, cannot meet the need both for both in-depth knowledge of the diagnostics industry and the ability to run diagnostic tests in a clinical laboratory, ResearchDx said. And diagnostics companies “lack the ability to perform clinical testing and have an incentive to steer diagnostic development toward their existing products’ technology platforms.”
ResearchDx said its co-founders and principals—Philip Cotter and Mat Moore—“have a passion for the advancement of personalized medicine.” Cotter was vice president and laboratory director at Biocept, laboratory director at the Illumina Clinical Services Laboratory and laboratory director for Combimatrix Molecular Diagnostics.
Moore was vice president of R&D at Neogenomics, vice president of R&D at CombiMatrix Molecular Diagnostics and senior scientist at US Labs (Laboratory Corporation of America).