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U.S. Department of Health and Human Services

Safety

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At-Home Genetic Tests

Audience: Consumers and genetics healthcare professionals

[Posted 07/31/2006] FDA, the Federal Trade Commission, and the Centers for Disease Control and Prevention alerted consumers about the facts surrounding the direct-to-consumers marketing of genetic tests.

According to the FDA, which regulates the manufacturers of genetic tests, and the CDC, which promotes health and quality of life, some of these tests lack scientific validity, and others provide medical results that are meaningful only in the context of a full medical evaluation. The FDA and CDC say that because of the complexities involved in both the testing and the interpretation of the results, genetic tests should be performed in a specialized laboratory, and the results should be interpreted by a doctor or trained counselor who understands the value of genetic testing for a particular situation.

[July 31, 2006 – News Release – FDA/CDRH/OIVD]