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Medical News and Perspectives
September 22/29, 2010

Inconsistent Results, Inaccurate Claims Plague Direct-to-Consumer Gene Tests

JAMA. 2010;304(12):1313-1315. doi:10.1001/jama.2010.1328

Despite having lived for 13 years with a pacemaker to treat atrial fibrillation, one “undercover consumer” participating in a recent Government Accountability Office (GAO) investigation was told by 4 companies providing direct-to-consumer genetic tests that he had only an average or below-average risk for developing the condition.

His results and those of 4 other DNA donors who participated in the GAO investigation raise serious concerns about the clinical validity and reliability of genetic tests that are marketed directly to consumers. Additionally, when the investigation probed the companies' marketing practices, it identified deceptive or misleading claims being used to sell the tests or other products.

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