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23andMe Launches TV Ad Campaign For DTC Gene Testing Service While Seeking 510(k)

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.

23andMe launched a national TV ad campaign for its personal genetics testing services Aug. 5 even while the company seeks 510(k) clearance for its Personal Genome Service genetic test.

23andMe is one of the leading direct-to-consumer genetic testing services, offering consumers the ability to have their DNA analyzed for disease risk, drug response, physical traits and ancestry information. Consumers...

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