FDA Comes Down Hard On 23andMe, Putting Consumer-Directed Genetic Testing On Notice
The agency tells direct-to-consumer genetic testing company 23andMe in a strongly-worded warning letter that it should immediately stop marketing its Personal Genome Service until it can gain clearance. The firm says it will address the agency’s concerns.
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23andMe’s battle with FDA is another reminder that genomics is rapidly becoming incorporated not only into the clinic, but also into everyday life. It is forcing FDA and other agencies to take a stand on critical technical, legal, and ethical issues, which will influence the strategies of medical diagnostics and pharmaceutical companies as well as labs performing tests directly for the consumer.
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