Who Regulates Genetic Tests?
Publication Date: February 2006
Publisher: Genetics and Public Policy Center
Author(s): Gail Javitt; Audrey Huang
Research Area: Health
Keywords: Genetic testing; Regulation
Type: Brief
Coverage: United States
Abstract:
Like other diagnostic laboratory tests, genetic tests are subject to some federal regulatory oversight. Currently there is no uniform or comprehensive system to assess
the analytic and clinical validity of tests before they are offered to patients, and there are no laboratory standards that specifically address molecular or biochemical genetic
testing or require laboratories to enroll in proficiency testing programs that assess their ability to perform the tests correctly.
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