In Vitro Diagnostics Services | Research, Development, Test, and Evaluation
Emerging Infectious Disease
MRIGlobal’s emerging infectious disease services span all stages of the in vitro diagnostic product development process, beginning with research and development through FDA Clearance.
Our infectious disease diagnostics services include development of methods, platforms, and molecular and immunological assays. These services provide a turnkey, outsourcing solution for commercial companies and government agencies seeking to accelerate product development into later clinical verification and validation phases. In addition, MRIGlobal’s CRO offerings include BSL-2+ and BLS-3 biocontainment laboratories, CAP accredited CLIA reference laboratories, and clinical sample acquisition.
MRIGlobal offers comprehensive assay and protocol development for the diagnosis of emerging infectious disease:
- Assay Design
- Assay Development
- Sample Prep Design & Development
- Analytical Verification Studies
- Clinical Validation Studies
- CLIA Reference Laboratory Studies
- Comparator Studies
- Bridging Studies
- Stability Studies
- Genomics-based methods for clinical diagnostics
- Genomics-based methods biosurveillance
- Genomics-based methods forensic applications
- Ultra-portable laboratory platforms and field-forward genomics
- Sequence Assembly, Genome Mapping and Annotation, Gene Ontology, and Visualization
- Turn-key Molecular Assay Design Algorithms
- Genotype-to-Phenotype Predictive Modeling
MRIGlobal’s biocontainment facilities have more than 64,000 ft2 of BSL-2, BSL-2+ and BSL-3 workspace, including three BSL-3 labs contiguous with ABSL-3. Our services include:
- Instrument development, testing, and evaluation
- Decontaminant technology development, testing, and evaluation
- Fate and transport studies
- Other threat agent research options
Our facility includes the College of American Pathologists (CAP) accredited and Clinical Laboratory Improvement Amendments (CLIA) certified laboratories. The laboratories are designed specifically for use for all phases of in vitro diagnostic product development to meet FDA clearance requirements.
Kyle Parker inspects a reagent cartridge prior to loading clinical samples for analysis with a point-of-care device.
MRIGlobal scientists conduct research and development with commercial companies to improve emerging infectious disease diagnostic technologies with the goal of advancing these technologies into verification and validation phases of clinical product development.
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MRIGlobal looks forward to contributing our expertise where it matters most.
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