FAQ
Contract Diagnostics Organization
Q: What is a Contract Diagnostics Organization (CDO)?
A CDO is a unique entity where all IVD diagnostic services are integrated within one organization. A CDO provides the opportunity to work with one provider for all necessary in-vitro diagnostic services, concept to regulatory approval, in the IVD development pathway. As a CDO, ResearchDx provides diagnostic services to biopharmaceutical companies seeking to develop an FDA-approved companion diagnostic and to diagnostics companies who may lack specific expertise or resources to complete product development.
Q: Why would you choose a CDO?
A CDO eliminates the need to source and manage multiple vendors for the various IVD diagnostics services needed to develop and complete your diagnostic assay. All required services are integrated into a single organization that attains operational and cost efficiencies as well as accelerating the time to market. Because your IVD diagnostic and drug are developed in parallel, shifting needs and priorities during the drug development process and clinical validation can be accommodated efficiently when your diagnostics resource is a single partner.
Q: How are projects and client communications managed at ResearchDx?
Every project is unique and led by an experienced Project Manager (PM). The PM, as the central point of contact, will guide, coordinate and manage all project activities, including client communications. Unlike working with multiple partners with multiple points of contact, when unexpected interruptions or delays occur that will impact the IVD development timelines, a CDO can readily adjust with a single phone call to the PM.
Companion Diagnostics
Q: What is a companion diagnostic?
A companion diagnostic is an in vitro diagnostic assay designed to qualify a person for a therapeutic intervention or identify a person that will not respond to a particular intervention. Other uses include customizing drug dosage based on metabolism biomarker status or monitoring therapeutic treatment. Drug and IVD development occur simultaneously in a parallel co-development path.
Q: What are key challenges for a pharmaceutical company developing a companion diagnostic?
The traditional path for pharmaceutical companies needing to develop an FDA-approved companion diagnostic is to outsource and coordinate the various diagnostic activities with multiple vendors. Since every diagnostic activity requires in-depth knowledge in those areas, biopharma may be coordinating development activities with many different vendors for biomarker identification, assay and kit development, platform identification and adaptation, multicenter clinical trial services, regulatory IVD compliance services, accredited clinical laboratory services, IVD manufacture and deployment. The coordination of timelines is complex and challenging. When unexpected results or delays occur during drug development or trials, multiple vendors must be notified and activities altered or ceased.
Since a clinical laboratory will ultimately purchase and offer the final approved IVD, employing a technology and platform that is accepted and common in the community is a vital consideration for deployment. Oftentimes, large diagnostic companies are approached that are predisposed to using their existing technology and platforms that capitalize on their own internal synergies and interests instead of exploring what is best-suited for the IVD.
At ResearchDx, we simplify the process by being a single source vendor that integrates all IVD diagnostic development activity. We provide an agnostic approach to selecting technology and platforms as we have no competing interests or arrangements with manufacturers of instrumentation. We focus on our client’s needs to ensure their objectives are being met by using technology and platforms that align with their goals and commercialization strategies. Building and validating assays of any type, start-to-finish, is what we do.
Learn more about FDA-Approved companion diagnostics.
Q: What are “custom” diagnostics services?
At ResearchDx, we provide IVD diagnostic development services tailored specifically to the needs of the client. Every project is unique. Together, programs are designed and developed to meet client specifications, goals and commercialization strategies.
Custom IVD Diagnostics
Q: What is a common example of a custom service?
We work with clinical laboratories who may not have the resources to initiate or complete development of a Laboratory Developed Test (LDT). LDTs have become a regulatory focus in recent years as they have similar clinical utility to current medical devices that require compliance to certain regulations and FDA approval. Therefore, studies showing accuracy, clinical and analytical validity and clinical utility have become increasingly important. At ResearchDx, we develop LDTs and perform the various studies that are increasingly requested by the more stringent CLIA regulations and other accreditation bodies.
Learn more about IVD Diagnostics development.
Technology and Platform Development Capabilities
Q: Does ResearchDx have associations with instrument manufacturers that would bias platform recommendations?
No, we have no proprietary testing platform or arrangements or partnerships with any instrument manufacturers. Selection of the platforms are those best-suited to the assay and the client’s needs.
Q: Are there limitations for sample types for use in assay development?
The type of sample is determined by the assay requirements and the applied technology; however, the overall assay specifications are predetermined by the client’s goals and commercialization strategy.
Q: If I have specific questions regarding your ability to design an assay for a particular platform, whom do I call?
We would be happy to discuss any questions you may have, give us a call at 866-225-9195 or 949-812-6902 or contact us.