FDA orders 23andMe to stop selling DNA test kits
Federal regulators have ordered the genetic testing company 23andMe to stop marketing its mail-order DNA sampling kits. The FDA says 23andMe has not proven the validity of the kit’s results. 23andMe’s co-founder is Anne Wojicki, the estranged wife of Google’s Sergey Brin, and Google is a major backer of the company.
The website offers a mail-in service that lets you know more about your ancestry, and in turn information on your health and the future of your wellbeing. 23andMe includes analysis of a number of health conditions, diseases you might be a carrier of, and how your body might respond to specific drugs.
The FDA is worried about patients acting on false results — getting treatment they don’t need if those results are false positives, putting off doctor’s visits if they get false negatives. The FDA wants to make sure 23andMe’s kits do what they say they’re going to do, and the agency says it doesn’t have assurance from 23andMe that the test works the way the company says it does.
23andMe has 15 business days to respond to the FDA. If they don’t respond in a way the FDA is happy with, the FDA may take additional action.
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