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News From the Food and Drug Administration
August 16, 2016

Regulating Genetic Tests

JAMA. 2016;316(7):703. doi:10.1001/jama.2016.10675

As part of its role in the federal Precision Medicine Initiative, the FDA has released draft recommendations outlining the agency’s approach toward ensuring that diagnostic tests based on next-generation sequencing technology are safe and effective.

The current regulatory landscape is appropriate for conventional tests that measure limited indicators of disease, such as blood glucose or cholesterol levels, agency officials said. But new sequencing technologies that can examine millions of DNA variants at a time require a more flexible, streamlined approach that’s adapted to these novel types of tests.

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