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At-home genetic tests scrutinized

This article was originally published in The Gray Sheet

Executive Summary

"No at-home genetic tests have been reviewed by the FDA, and the FDA has not evaluated the accuracy of their claims," writes the Federal Trade Commission in a July 27 consumer fact sheet. FTC notes that at-home genetic tests, which range in price from $295 to $1,200, are not backed by "valid scientific studies" showing their safety and efficacy. "Because of the complexities involved in both the testing and the interpretation of the results, genetic tests should be performed in a specialized laboratory," with results interpreted by a clinician, the fact sheet notes. FTC has been criticized for its limited oversight of genetic testing claims (1"The Gray Sheet" Nov. 3, 2003, p. 16)...

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