FDA, 23andMe settlement setback for personal analytics

FDA, 23andMe settlement setback for personal analytics

Summary: Genetic testing service 23andMe said it will comply with an FDA order and that means you'll get a DNA data dump without any interpretation. What's the point?


23andMe said it will only provide ancestry analysis for its genetic testing service and raw data without interpretation following a scuffle with U.S. Food and Drug Administration.

In other words, the most important part of 23andMe's business and a cog in the quantified self movement---you and your health as a ecosystem to be measured and analyzed---took a hit.

The FDA's beef was that 23andMe, which offered genetic tests and then analyzed the data for individuals, shouldn't be able to advertise and offer analysis without its approval. In a blog post, 23andMe CEO Anne Wojcicki said the company had been talking to the FDA since 2008 and submitted an application for clearance in July 2012.

So now 23andMe will comply with the FDA and end consumer access to its health related genetic tests pending a review. What's left is ancestry-related analysis and raw genetic data without the interpretation.



Add it up and 23andMe now has to offer a big data firehouse without the analytics. Thanks for nothing.

Customers who received or purchased kits for health-related results before Nov. 22 will still have access to the data and analysis.

It has been an open question whether consumers would rush out to get their genes analyzed to flag potential problems, but enough folks used 23andMe to indicate that there's a business there. The FDA is late to the game and hampering what could be called a window into personal analytics.

Topics: Big Data, Government, Health

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  • FDA goes Feudal

  • Direct-to-Consumer Genetic Testing: Let the Debate Begin

    With continued development in the world of genomics, we will see more companies like 23andMe develop affordable direct-to-consumer tests, which will be met by questions regarding whether or not direct-to-consumer genetic tests should be regulated as the practice of medicine, as a medical device, and/or as personal health information?

    We recently published two articles covering both sides of the issue, which can be read here: http://lifesciencesnow.com/category/genetics/

    We'll also be hosting a complimentary webinar covering this issue next Thursday: http://reaction.dbr.com/rs/vm.ashx?ct=24F76F1DD1E10AEDC1D180ABDB2B901DDFBE7BB3D38714DD4CF371647BF8D90DDD78031
    Life Sciences Now
  • Pending a review?

    By whom? By a court, I would hope.

    Since there really isn't any risk to these sorts of analyses (other than it might be wrong) all that really should be required is a disclaimer.
    John L. Ries
  • oh please, this is TOTALLY reasonable

    Take the data dump to a professional who can interpret in context of you what the data says.
    What that were doing was 'junk science' and , as Leo Laporte pointed out, a toy rather than a diagnostic. Telling people false/useless medical data should always be illegal unless stated with large fonts in the beginning , middle and end that the report is not a diagnosis.