Monday, 25 November 2013

23andMe battles US FDA

On Nov 22, 2013 Ann Wojcicki, CEO of 23andMe, Inc. was sent a letter by the US Food and Drug Administration stating that "23andMe must immediately discontinue marketing the PGS (Personal Genome Service) until such time as it receives FDA marketing authorization."
The letter cites 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications over more than a year attempting to bring 23andMe into compliance with FDAs interpretation of US regulation.
FDA's concern is 23andMe's health interpretation of the DNA results, the ancestry service would only be impacted if it was sideswiped. More likely the company will continue its battle - as of noon EST on Monday there is no change evident on the site.
However, to be on the safe side I've downloaded the raw data for those I've had tested by the company. From your 23andMe account home page click your profile, fourth from the left on the top menu bar. Select BROWSE RAW DATA, then select DOWNLOAD which is second from the right in the second menu bar from the top. You need to re-enter your password and answer you secret question before download starts. Then save the zipped file.  You might also want to save the health overview file. Click on HEALTH OVERVIEW from your main page, print to pdf and save.

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