On Thu, Nov 28, 2013 at 4:05 PM, Jeswin <phillyj101@gmail.com> wrote:
I thought the whole hullabaloo was the fact they were interpreting thedata. Sure, you need accurate sequence reads but don't you cross a
certain regulatory line when you start interpreting the data? Doesn't
it then become a medical device like a glucose meter? I think the FDA
sees potential for misuse. Didn't they start to regulate smartphone
app makers who started to venture into the medical device area?
That was my impression as well, though I didn't read the letters myself. If 23andMe wants to give people their genetic data and let them analyze it themselves, that would probably be fine. But if you start telling people that they have genes that predispose them to a certain disease, they may take action based on that and suddenly 23andMe is providing a medical diagnosis.
I saw the other thread where some people were upset that the FDA would do such a thing, and while I am generally a fan of freedom of information I can also see the argument against 23andMe giving people this kind of information about themselves without the proper context or responsibility.
-Dan
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