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MIDWEST RESEARCH INSTITUTE RECEIVES FULL ACCREDITATION FROM COLLEGE OF AMERICAN PATHOLOGISTS
National Accreditation ensures highest laboratory standard

PALM BAY, Fla. – Midwest Research Institute (MRI) has been awarded full accreditation by the Commission on Laboratory Accreditation of the College of American Pathologists (CAP). Known as the quality standard for clinical laboratories, MRI’s CAP accreditation was based on the results of a recent stringent inspection requiring the lab pass comprehensive inspection of laboratory records and quality procedures. All management, facilities, safety and quality programs were held against this standard and found to be in complete compliance with no deficiencies of record. MRI’s greater than 65 years of experience in independent scientific research led to this accreditation through rigorous inspections of all laboratory policies and procedures.

MRI’s Clinical Molecular Diagnostics Laboratory offers dedicated facilities and staff committed to support molecular diagnostics assay developers with clinical trials and clinical validation for PMA and 510k submission to the Food and Drug Administration. MRI’s Palm Bay laboratory registrations and certifications – all of which add up to top level accreditation within the industry—include:

•         Certificate of Registration from the U.S. Department of Health and Human Services Centers for Medicare & Medicaid Services (CMS) regulated through the Clinical Laboratory Improvement Amendments (CLIA)
•         Accreditation from the College of American Pathologists (CAP)
•         State of Florida Laboratory License enabling the laboratory to begin high complexity clinical testing services
•         Certification for ISO/IEC 17025:2005

According to MRI officials, molecular diagnostics is one of the fastest growing sectors of the in vitro diagnostics industry. This growth, coupled with evolving FDA guidance and regulatory requirements for in vitro diagnostic devices, has created a need for more CLIA certified laboratories with the capability for conducting validation studies and clinical trial testing for newly developed diagnostic tests.

This accreditation and licensure allows MRI’s Clinical Molecular Diagnostics Laboratory to offer dedicated facilities and staff committed to support molecular diagnostics assay developers with clinical trials and clinical validation for PMA and 510k submission to the Food and Drug Administration.

•           Molecular diagnostic assay development and validation
•           Clinical trials support
•           Comparisons to “Gold Standards” or predicate devices
•           Assay and platform evaluation at all levels of development

In addition to state-of-the-art laboratories, MRI has an expert staff including Ph.D. scientists with experience in diagnostic assay development and who are dedicated for pre-submission activities. Support staff are licensed for performing clinical laboratory services and are highly trained in Molecular Biology, Genetics, Microbiology, and Immunology. MRI’s Florida Division also has extensive experience in supporting large contracts with the U.S. government to validate platforms and assays for use by public health and criminal laboratories to identify pathogens within complex environmental and clinical samples.

Midwest Research Institute (MRI), a not-for-profit scientific/engineering organization with nearly 2,800 employees under management nationwide, performs scientific research and engineering technical services for clients in government, industry, and academia. Established in 1944, MRI conducts technical services in the areas of national security and defense, energy and environment, life sciences, food and agriculture, and transportation safety. With headquarters in Kansas City, Mo., MRI also has operations in Colorado, Florida, Kansas, Maryland, North Carolina, Pennsylvania, Virginia, Washington, D.C., and West Virginia.

MRI is a partner in and chair of the Alliance for Sustainable Energy, LLC, which manages and operates the National Renewable Energy Laboratory (NREL) in Golden, Colo., for the U.S. Department of Energy.