Diagnostics - MRIGlobal

Clinical Diagnostics

Customized Solutions for Diagnostics

MRIGlobal is your trusted partner for contract research and development. From early product design to FDA 510(k) or CE-IVD submission, we offer a broad and deep portfolio of laboratory services, facilities, and scientific expertise to support and accelerate the development of in-vitro diagnostic products.

Extensive Nucleic Acid Sample Prep and Isolation Services
PCR Test, Evaluation, Validation Services (TEVS)
Product Development Services
Diagnostic Product Test and Evaluation Services
CLIA (CAP accredited) Reference Laboratory Services
Influenza Virus Research Program
Next Generation Sequencing
Assay Design, Verification, and Validation Services
Unique Access to Samples
Biomarker Development
EIA and Bead-based Assays
Bacterial and Viral Pathogens, including High Path Influenza and Select Agents
Preparation and Design of Package Inserts
Analytical Methods Development and Technology Transfer
Engineering, Software, and Systems Integration Services
BSL-3 and BSL3+ Laboratories

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Featured Work

MRIGlobal Supports Global Health with BARDA Medical Countermeasures Development

Under the 5-year, Indefinite Delivery/Indefinite Quantity contract with a potential value of up to $100 million, MRIGlobal will support BARDA's mission to develop medical countermeasures and supportive reagents and assays against chemical threat agents for regulatory acceptance in the U.S. “MRIGlobal has a rich history of providing innovative science and technology solutions to BARDA and we are honored to continue…

Assay Design & Development Solutions

R&D, IVD, LDT, CLIA-WAIVABLE, and RUO products
FDA 510(k), PMN, and CE Mark Submissions

Analytical Verification Studies

Limit of Detection
Inclusivity (Reactivity)
Exclusivity (Cross-Reactivity)
Interfering Substances
Reproducibility
Sensitivity and Specificity

Limit of Detection
Inclusivity (Reactivity)
Exclusivity (Cross-Reactivity)
Interfering Substances
Reproducibility
Sensitivity and Specificity

Clinical Validation Studies

Limit of Detection
Inclusivity (Reactivity)
Exclusivity (Cross-Reactivity)
Interfering Substances
Reproducibility
Sensitivity and Specificity

Stability Study Services

Accelerated and Real Time (-80C, -20C, 4C, RT)

CLIA (CAP accredited)

CLIA (CAP accredited) Reference Laboratory Services & Support for Diagnostics Comparative Studies

Dedicated, high-quality resources for rapid turnaround

CAP-accredited CLIA Reference Laboratory
BSL-3 and BSL-3+ Laboratories for Handling Emerging Infectious Diseases & Select Agents
Highly Secure Facilities
60+ Scientists, Engineers, Bioinformatics Specialists and Program Managers available to support and develop your product

We deliver high-quality solutions for every client, every day

cGLP
cGMP
Quality System Regulation (QSR)
ISO 9001
ISO 17025
CLIA (CAP-accredited) Reference Laboratory
Successful audit history with FDA, CAP, ISO, DoD, CDC, EPA, DHA, USDA

Trusted Partner in Product Development Since 1944

From early product development to FDA or CS-IVD approval, MRIGlobal provides scientific and laboratory services for the development of molecular diagnostic products that will accelerate your timeline, provide high-quality, customized solutions and dedicated laboratory space and staff and allow you to retain intellectual property.