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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

Contact

Rich Masino
858-342-1574

Request Information

Featured Work

MRIGlobal Supports Global Health with BARDA Medical Countermeasures Development

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…

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Upcoming Events

  • Sun
    06
    May
    2018
    Wed
    09
    May
    2018

    ASM CVS (American Society of Microbiology Clinical Virology Symposium)

    Palm Beach County Convention Center in West Palm Beach, Florida

Customized Solutions

  • R&D, IVD, LDT, CLIA-WAIVABLE, and RUO products
  • FDA 510(k), PMN, and CE Mark Submissions
  • 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
  • Limit of Detection
  • Inclusivity (Reactivity)
  • Exclusivity (Cross-Reactivity)
  • Interfering Substances
  • Reproducibility
  • Sensitivity and Specificity
  • Accelerated and Real Time (-80C, -20C, 4C, RT)
  • 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.