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Who Regulates Genetic Tests?

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Publication Date: February 2006

Publisher(s): Genetics and Public Policy Center

Author(s): Gail Javitt; Audrey Huang

Funder(s): Pew Charitable Trusts

Funder(s): Pew Charitable Trusts

Topic: Health (Medical research and technology)

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.