In Vitro Diagnostics EXPERTISE at MRIGlobal
Product Development to Improve Patient Health
In vitro diagnostic tools increase the opportunity for reliable diagnoses, resulting in more effective treatment.
We provide scientific and subject matter expertise to expand and accelerate the delivery of high quality clinical diagnostic products.
MRIGlobal offers government and commercial clients services that include assay design and clinical development through regulatory submission. We provide extensive research and product development expertise; facilities, analytical services, clinical trial site, and clinical trial services and support; and regulatory guidance to support FDA submission filings.
About In Vitro Diagnostics
MRIGlobal manages a variety of in vitro diagnostic programs.
Our solutions range from the development of cutting-edge molecular and immunological assays focused on diagnosing infectious disease to the advancement of novel, highly sensitive diagnostic assays for confirming exposure to radiation and chemical agents.
We offer a broad range of research and clinical laboratory services to accelerate product development and reduce time to market.
MRIGlobal has more than 60 dedicated, experienced staff with expertise in molecular biology, immunology, microbiology, bioinformatics, and engineering. This includes staff expert in clinical diagnostic quality and regulatory frameworks, and program management. Our culture of trust and integrity, in partnership with our clients, solves complex clinical diagnostic problems to help create a safer, healthier, more sustainable world.
Featured Program | Diagnostics
BARDA – Development of FDA-Cleared Biological Threat Agent Diagnostic Assays
This program focuses on the development and validation of a FDA-cleared diagnostic assay for Bacillus anthracis, the disease causing agent of anthrax. Together with ThermoFisher and MDC Associates, MRIGlobal is conducting advanced development of a real-time PCR-based multiplex assay for the presumptive diagnosis of anthrax using instrument platforms widely fielded in clinical laboratories. As part of a Design Control Process, analytical and clinical performance testing will be conducted to support 510(k) submissions to FDA.