FDA Points To Premarket Clearance For Direct-To-Consumer Genetic Tests
This article was originally published in The Tan Sheet
FDA tells direct-to-consumer genetic testing company 23andMe that it should immediately stop marketing its Personal Genome Service in a strongly worded, lengthy warning letter that experts say could provide guidance across the sector. The firm says it will address the agency’s concerns.
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The seller of a $99 direct-to-consumer genetic test service is running ads with actors discussing the values of learning one’s personal DNA profile. But the firm’s continued marketing of the testing services and now its high-profile ads may raise questions about the regulatory status of its offerings.
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