Tuesday, November 26, 2013

FDA orders 23andMe to halt sales of its its Saliva Collection Kit and Personal Genome Service

November 26, 2013
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(Credit: 23andMe Inc.)
The FDA has told 23andMe Inc., the Google Inc.-backed DNA analysis company co-founded by Anne Wojcicki, to halt sales of its Saliva Collection Kit and Personal Genome Service (PGS).
In a letter, the FDA said the company was acting “without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act (the FD&C Act)….”
“Most of the intended uses for PGS listed on your website, a list that has grown over time, are medical device uses [that] have not been classified and thus require premarket approval or de novo classification.”
“We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission,” 23andMe responded in a statement. “Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.”
With more than 500,000 genotyped customers, 23andMe enables individuals to gain deeper insights into personal ancestry, genealogy and inherited traits. It offers $99 saliva-testing kits that customers can use at home and then send to the company for reports on how they might be at risk for a range of inherited health conditions and how they are likely to respond to certain drugs.


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