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Midwest Research Institute Launches Clinical Molecular Diagnostics Laboratory
Date:4/17/2009

Receives CLIA Certification and CAP Accreditation

PALM BAY, Fla., April 17 /PRNewswire-USNewswire/ -- To address the growing need for molecular diagnostics, officials at the Florida Division of Midwest Research Institute (MRI) announced today that they have established a Clinical Molecular Diagnostics Laboratory that is now fully accredited, licensed and operational.

MRI, headquartered in Kansas City, Mo., is one of the nation's leading independent scientific research organizations conducting contract research for business, government, and academia for 65 years.

In preparing for the Clinical Molecular Diagnostics Laboratory, MRI's Palm Bay laboratory applied for and received numerous registrations and certifications -- all of which add up to top level accreditation within the industry. The laboratory's accreditations 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 clinical testing services
  • Certification for ISO/IEC 17025:2005

According to MRI officials, molecular diagnostics is one of the fastest growing segments of the in vitro diagnostics industry. Growth in this sector, coupled with increasing FDA guidance for labeling in vitro diagnostic devices requiring clinical validation or clinical trials, has created a need for more CLIA certified laboratories with the capability for conducting clinical tests for diagnostic kits and reagents.

"MRI anticipated the need for more CLIA certified laboratories required to support diagnostics R&D within the proper regulator
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SOURCE Midwest Research Institute
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