Re: [DIYbio] Text of 23andme email

On Wed, Nov 27, 2013 at 3:28 PM, Bryan Bishop <kanzure@gmail.com> wrote:
> They blasted this out a few minutes ago:
>
> """
> Dear 23andMe Customers,
>
> I wanted to reach out to you about the FDA letter that was sent to 23andMe
> last Friday.
>
> It is absolutely critical that our consumers get high quality genetic data
> that they can trust. We have worked extensively with our lab partner to make
> sure that the results we return are accurate. We stand behind the data that
> we return to customers - but we recognize that the FDA needs to be convinced
> of the quality of our data as well.
>

I thought the whole hullabaloo was the fact they were interpreting the
data. 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?

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