FDA Tells Google-Backed 23andMe to Halt DNA Test Service
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23andMe Inc., the Google Inc.-backed DNA analysis company co-founded by Anne Wojcicki, was told by U.S. regulators to halt sales of its main product because it’s being sold without “marketing clearance or approval.”
The Saliva Collection Kit and Personal Genome Service, or PGS, tells users whether they carry a disease, are at risk of a disease and would respond to a drug. Most of the uses fall into the category of a medical device and require Food and Drug Administration approval, the agency told the Mountain View, California-based company in a Nov. 22 letter made public today.