FDA warns genetic testing service to halt sales, seek formal approval

The FDA has order genetic testing services company 23andMe Inc. to immediately discontinue marketing its Saliva Collection Kit and Personal Genome Service without agency clearance.In a letter to company founder and chief executive Anne Wojcicki dated Nov. 22 and made public today, the FDA said most of the intended uses for the service are “medical device uses … that require premarket approval or de novo classification, as the FDA has explained to you on numerous occasions.”The warning letter points out that the agency has been “diligently working” to help 23andMe (Read more...)

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