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Fda, Clia, Or A "Reasonable Combination Of Both": Toward Increased Regulatory Oversight Of Genetic Testing, Douglas A. Grimm

University of San Francisco Law Review

This Article examines the current regulatory scheme for genetic testing and calls for a unification of the testing standards. It advocates consolidating the standards under a single governmental agency, FDA, in order to ameliorate the potential for immediate and future harm to patients and their families. In order to be effective, future regulations must apply to all providers of genetic testing and create meaningful, reasonable criteria for testing processes and outcomes.