solutions for a safer, healthier world

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SOLUTIONS FOR A SAFER, HEALTHIER WORLD MRIGlob In Vitro al Diagnostics Solutions Advantages: • A Culture of Trust & Integrity • Dedicated Project Teams • Technology Agnostic • CAP-Accredited CLIA Laboratory • BSL-3 Laboratories for Infectious Disease & Select Agents • Highly Secure Facilities and Environment • 60+ Dedicated Scientists, Engineers, & Program Managers Quality Assurance: • ISO 9001, ISO 17025 • GLP & cGMP • CAP-Accredited CLIA Laboratory • Successful Audit History with FDA, CAP, ISO, CDC, & USDA Your trusted partner for contract research since 1944 Applications: • Sample Preparation and Processing • Nucleic Acid Isolation and Amplification • Immunological Assays • Microbiology • Next Generation Sequencing and Bioinformatics Rich Masino, Global Head of Business Development Global Health Surveillance & Diagnostics, Commercial Division O. 816.326.5021 • C. 858.342.1574 • [email protected] Ebola sample inactivation training inside the mobile diagnostic laboratory at Ratoma, Guinea. Contact: Basic Research Prototype Design or Discovery Preclinical Development FDA Filing Approval & Launch Clinical Phase 1 Phase 2 Phase 3 Phase 4 Target Selection Target Validation Marker Assay Validations Analytical Validation Diagnostic Kit Clinical Validation Diagnostic Kit, Final Platform Clinical Validation Label Considerations Based on Market Status Identification of Stratification Clinical Utility for Stabilization Label Considerations Based on Trial Platform Change MRIGlobal Capabilities MRIGlobal solves technological challenges facing government and industry, applying scientific expertise to the full spectrum of research and development. As an independent, not-for-profit institute, we deliver innovative thinking and unbiased results to our clients. MRIGlobal capabilities - Our broad portfolio of laboratory solutions, expertise, and flexibility bring your products to market faster.

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SOLUTIONS FOR A SAFER, HEALTHIER WORLD

MRIGlob In Vitroal Diagnostics Solutions

Advantages:• A Culture of Trust & Integrity• Dedicated Project Teams• Technology Agnostic• CAP-Accredited CLIA Laboratory• BSL-3 Laboratories for Infectious Disease & Select Agents • Highly Secure Facilities and Environment • 60+ Dedicated Scientists, Engineers, & Program Managers

Quality Assurance:• ISO 9001, ISO 17025• GLP & cGMP• CAP-Accredited CLIA Laboratory • Successful Audit History with FDA, CAP, ISO, CDC, & USDA

Your trusted partner for contract researchsince 1944

Applications:• Sample Preparation and Processing• Nucleic Acid Isolation and Amplification• Immunological Assays• Microbiology• Next Generation Sequencing and Bioinformatics

Rich Masino, Global Head of Business Development Global Health Surveillance & Diagnostics, Commercial DivisionO. 816.326.5021 • C. 858.342.1574 • [email protected]

Ebola sample inactivation training inside the mobile diagnostic laboratory at Ratoma, Guinea.

Contact:

BasicResearch

PrototypeDesign orDiscovery

PreclinicalDevelopment

FDA FilingApproval &

Launch

Clinical

Phase 1 Phase 2 Phase 3 Phase 4

TargetSelection

TargetValidation

Marker Assay Validations

Analytical ValidationDiagnostic Kit

Clinical Validation Diagnostic Kit,Final Platform

ClinicalValidation

Label ConsiderationsBased on Market Status

Identification ofStratification

Clinical Utilityfor Stabilization

LabelConsiderationsBased on Trial

Platform ChangeMRIGlobalCapabilities

MRIGlobal solves technological challenges facing government and industry, applying scientific expertise to the full spectrum of research and development. As an independent, not-for-profit institute, we deliver innovative thinking and unbiased results to our clients.

MRIGlobal capabilities - Our broad portfolio of laboratory solutions, expertise, and flexibility bring your products to market faster.

MRIGlobal is an independent, not-for-profit life sciences organization serving government and industry clients for over 70 years

Missouri • Colorado • Florida • Maryland • Virginia • Kansas • Washington, D.C. 425 Volker Blvd., Kansas City, Missouri 64110 | Phone: (816) 753-7600 | Fax: (816) 753-8420

www.mriglobal.org | www.mriglobaldx.com | www.mriglobalsolutions.org 2

Global Health Security Solutions for Infectious Disease Detection, Diagnostics, and Medical Countermeasures

Contact:

• Biocontainment Lab Operations and Support• Assay Design, Development, and Validation• Rapid Engineering and Device Prototyping• Global Partnership Engagement• Medical Countermeasures• Pre/Nonclinical Studies Requiring High Containment

Joseph Bogan Jr., Ph.D., Director, Global Health Surveillance & Diagnostics 240.361.4005 • [email protected]

MRIGlobal is dynamic, nimble, and able to respond quickly to rapidly changing global health challenges. In time of crisis, MRIGlobal reliably mitigates delays and specific challenges that arise from global operations.

Trainee preparing to exit the sample inactivation/extraction unit of the mobile diagnostic laboratory at Conakry, Guinea. MRIGlobal continues to support training and sustainment of these laboratories as contracted by the USG.

APHL, CDC, DoD, Sierra Leone MoH, MRIGlobal, PHE, WHO and other key collaborators in front of Central Public Health Reference Laboratory in Lakka, Sierra Leone.

From years of expertise comes sound relationships. MRIGlobal builds cooperative research partnerships that provide ongoing mentorship for sustainable and programmatic success.

Mobile diagnostic laboratory at Conakry, Guinea. MRIGlobal deployed these labs to Guinea and Sierra Leone under a USG contract to support the Ebola outbreak.

MRIGlobal: Your Trusted Partner