MRIGlobal’s Diagnostics Services Facilitate New Product Development
MRIGlobal’s highly experienced scientists in the Molecular and Clinical Diagnostics laboratories are dedicated to the development, evaluation, and validation of molecular diagnostic assays for product development, and clinical trials/studies for new molecular diagnostic tests.
MRIGlobal’s in vitro diagnostics and clinical diagnostics labs operate in accordance with the requirements of the U.S. Food and Drug Administration (FDA) regulations for Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and the Clinical Laboratory Improvement Amendments (CLIA).
Our Capabilities:
- Assay development for manufacturing services, for GMP and non-GMP standards
- Reagent and reaction optimization
- Optimized assay design and feasibility, including workflow and bench procedures
- Laboratory-developed assays
- Oligonucleotide designs
- Assay specification reports
- Esoteric testing and third-party evaluation
- Clinical validation and clinical trial services
- Pre-market submission support, including technical verification and comparison studies
- Post-production marketing and technical support services
- Dedicated facilities, accredited by the College of American Pathologists
MRIGlobal’s Molecular and Clinical Diagnostics Successes:
- Assay Development and Assessment: MRIGlobal has developed or evaluated assay formats including various qualitative and quantitative molecular and immunoassay designs using single and multiplexed approaches.
- Technology Transfer to industry and government clients: MRIGlobal has delivered custom assay designs, optimizations, risk management, training, method and process documentation, as well as clinical validation and trial services, facilitating timely FDA approval of new products.
- Biorepository: MRIGlobal maintains a collection of more than 10,000 samples of high quality clinical specimens for assay verification and validation services. MRIGlobal’s infrastructure, facilities, and quality systems adhere to the best practices of the International Society for Biological and Environmental Repositories.