FDA Tells 23andMe to Halt Marketing Personal Genome Service | GenomeWeb

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has told 23andMe that it must stop marketing its spit test and genome service to consumers because it has failed to address FDA's questions about the clinical and analytical validity of the product.

In a letter sent to company CEO Anne Wojcicki on Friday, the FDA said 23andMe must cease marketing the Saliva Collection Kit and Personal Genome Service to consumers immediately, and may not start marketing it again until it has received the agency's authorization.

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