ResearchDx
Founded in 2008, Philip D. Cotter, PhD, and Mathew W. Moore, PhD, established ResearchDx as the first CDO (diagnostic-focused CRO) business model to integrate and manage all IVD diagnostic development expertise and services within a single organization. This decision was driven by the accelerating demands of personalized medicine and the need for a more straightforward path for aligned development and regulatory approval of a therapeutic and its companion diagnostic.
Although pharmaceutical companies have well-established pathways for drug development, none exist for the co-development of FDA-approved companion diagnostics. To acquire the diagnostics expertise needed, biopharma must outsource to multiple vendors or a large diagnostic company. If they outsource to multiple vendors, they must manage a complex process that is neither flexible nor dynamic. If they outsource to a large diagnostic company, diagnostic development will be limited to its existing technology, product lines, and platforms, which may not be best suited for the companion diagnostic. The choice of platform also affects deployment in the clinical laboratories that may offer the test.
The ResearchDx business model reduces an over-burdensome process by its organizational structure without competing interests and allows for consideration of emerging molecular technologies in the development process.
ResearchDx Today
Customized or “genomic” therapeutics have become the focus for pharmaceutical discovery, generating the need for matching companion diagnostics. As a full-service diagnostics organization, we offer a ‘start-finish’ partnership for the co-development of companion diagnostics. Providing independent and unbiased guidance, we design, manage and coordinate all aspects of the diagnostics development process, from concept through regulatory approval, based on your goals and objectives. As a single outsourcing partner, we provide a flexible process adaptable to changing needs, priorities, and schedules.
Supported by our fully accredited clinical laboratory PacificDx, and our ISO 13485 and GMP compliant Manufacturing facility, Custom Diagnostics, ResearchDx offers a comprehensive range of services and specialty consulting for all diagnostic and co-development project needs.