FDA Ruling Makes Direct-to-Consumer Genetic Tests More Accessible

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Genome Magazine

November 10, 2017

Consumers are likely to see more genetic health risk tests on the market due to a new approval system announced by the Food and Drug Administration (FDA) on Monday.

Now, test manufacturers, such as 23andMe and Pathway Genomics, will only need to apply for approval of their companies and not the individual tests they produce. If companies meet the FDA’s requirements, they can send new genetic tests to market without additional review.

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Image: MIKI Yoshihito/CC BY 2.0

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