Custom Diagnostic Assays and Kit Design
Through our Custom Diagnostics division, we offer customized diagnostic, analytical and OEM assay and kit development and contract manufacturing for a variety of applications. We provide GMP or GLP environments to meet the needs of your project.
A few of the more common services we provide:
- Assays, reagents or final kits for research, preclinical (non-clinical) or clinical studies
- Final product kits for manufacture and U.S. or global distribution
- Molecular and non-molecular IVD development
- OEM diagnostic or analytical assays, reagents, kit components and final kits
- Certificates of Analysis (COA)
- Sample collection kits
Project Management and Scientific Support
Every project is tailored to your needs and has a dedicated project manager to guide and ensure your project stays on target with your goals and schedule. All projects are evaluated and designed by experienced PhD-level scientists and input from medical experts as needed. All development projects undergo analytical or clinical testing as required to meet quality and regulatory requirements, and/or the needs of the project.
We provide a broad range of approaches for customized product and kit development. Please see our list of technology and platform capabilities.
ResearchDx maintains manufacturing facilities and compliance with cGMP regulations as required by the Food and Drug Administration, 21 CFR part 820, for medical devices (Quality System (QS) Regulation/Medical Device Good Manufacturing Practices).