23andme and FDA

FDA had asked 23andme to stop its direct-to-consumer genetic testing and as a result 23andme has issued the following statement:

After discussion with officials from the Food and Drug Administration today, 23andMe will comply with the FDA's directive and stop offering new consumers access to health-related genetic tests while the company moves forward with the agency's regulatory review processes.

Customers who purchased kits on or after the FDA's warning letter of November 22nd will not have access to health-related results. Those customers will have access to ancestry-related genetic information and their raw data without 23andMe's interpretation of that data. They may receive health-related results in the future, depending on FDA marketing authorization.

Customers who purchased kits before November 22, 2013 will continue to have access to all the reports they've always had.

While I am disappointed at this turn of events, for our project it does not change much since 23andme will still provide raw data downloads as well as ancestry information.

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5 Comments.

  1. I really enjoy their health testing, too bad Govt thinks otherwise.

  2. Off Topic:
    if you have 23and me data+ have more than 75 relative finder results + you have south Asian ancestry + All 4 grandparents are from same ethnicity/caste/tribe, the please contribute to this thread.
    http://www.anthrogenica.com/showthread.php?1707-Relative-finder-distribution-of-South-Asian-Caste-and-Tribal-Haplogroups