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News From the Food and Drug Administration
April 7, 2015

FDA Okays First Direct-to-Consumer Genetic Test

JAMA. 2015;313(13):1306. doi:10.1001/jama.2015.2809

The personal genetics company 23andMe made regulatory history recently when the US Food and Drug Administration (FDA) announced that its carrier test for Bloom syndrome could be marketed directly to consumers, a first for a genetic test (http://1.usa.gov/1EgzEy4).

In November 2013, the FDA had sent 23andMe a warning letter directing the company to stop marketing its personal genome service because it had never demonstrated to the agency that its tests, which included information about genes linked to breast cancer and Alzheimer disease risk, were accurate, reliable, and clinically meaningful (http://1.usa.gov/1w39FJk).

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