FDA Warning Letter to 23andMe

Re:FDA Warning Letter to 23andMe by evan_ on Monday November 25, 2013 @11:05AM (#6794811)

23andMe is very clear at every step of the way that it is not diagnosing anything.

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Re:FDA Warning Letter to 23andMe by sqrt2 on Monday November 25, 2013 @11:18AM (#6794932)

This is what 23andMe said about that person's genome:

"Has two mutations linked to limb-girdle muscular dystrophy. A person with two of these mutations typically has limb-girdle muscular dystrophy."

Of course this not a diagnosis in a technical sense, but to a lot of people it will sound like it is. Specifically, I don't see how this is "very clearly" not a diagnosis.

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Re:FDA Warning Letter to 23andMe by anigbrowl on Monday November 25, 2013 @12:40PM (#6795514)

https://www.23andme.com/store/cart/

Knowledge is power.

23andMe empowers you to better manage your health and wellness.

$99 [Add a kit]

There are no disclaimers on this page, just an aphorism, an assertion, and a call to action. Now I like the idea of 23andme, I like the company, and I'm educated and skeptical enough to enjoy some fluffy scientism for a hundred bucks, but don't tell me they're not selling the hell out of this.

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Re:FDA Warning Letter to 23andMe by arrrg on Monday November 25, 2013 @11:21AM (#6794953)

Well, the FDA seems to think that 23andMe does market its product as diagnosing something. That’s what this whole letter is about.

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