To address the growing need for molecular diagnostics, officials at the Florida Division of Midwest Research Institute (MRI) announces 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 regulatory environment. MRI’s recent accreditation opens the door for the institute to participate in clinical trials and third party validation of clinical diagnostics," said Roy R. Swiger, Ph.D., Director of MRI’s Florida Division. "This initiative builds on MRI’s strengths and capabilities and we have positioned our laboratory to support this rapidly growing niche."
In particular, 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.
Specific services that MRI will provide include:
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 PhD scientists with experience in diagnostic assay development and are dedicated for pre-submission activities, licensed for performing clinical laboratory services, and 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 samples.
MRI will have an exhibit at the Clinical Virology Symposium that will be held in Daytona Beach, Fla, April 19-22 at the Hilton Daytona Beach Oceanfront Resort. MRI staff will be available at the exhibit to provide more detail on the Clinical Molecular Diagnostics Laboratory.
Source: Midwest Research Institute