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CTSI: CLIA - Translational Genomics Laboratory

The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA) to ensure quality laboratory testing. In order to utilize genetic information to guide therapy, both in research and in patient care settings, testing must be performed in a CLIA-approved laboratory environment. While most hospital-based clinical molecular pathology laboratories offer CLIA-approved genetic testing for diagnostics that are considered to be standard of care and reimbursable by health insurance companies, mechanisms do not exist in these facilities for clinical and translational genomics research.  For example, as part of the NIH-funded multicenter COAG Trial (the University of Maryland is one of 12 sites; Richard Horenstein,UM PI), rapid turn-around CYP2C9 and VKORC1 genotyping is required to test the efficacy of personalized warfarin dosing. Studies such as the COAG trial will provide the evidence base for our ultimate goal to implement genomic and pharmacogenetic testing into routine medical care to improve outcomes, minimize adverse events and decrease health care costs.