Text of 23andme email

[Bryan Bishop]

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.

23andMe has been working with the FDA to navigate the correct regulatory path for direct-to-consumer genetic tests. This is new territory, not just for 23andMe, but for the FDA as well. The FDA is an important partner for 23andMe and we will be working hard to move forward with them.

I apologize for the limited response to the questions many of you have raised regarding the letter and its implications for the service. We don't have the answers to all of those questions yet, but as we learn more we will update you.

I am committed to providing each of you with a trusted consumer product rooted in high quality data that adheres to the best scientific standards. All of us at 23andMe believe that genetic information can lead to healthier lives.

Thank you for your loyalty to 23andMe. Please refer to our 23andMe blog for updates on this process.

Anne Wojcicki
Co-founder and CEO, 23andMe

"""

- Bryan
http://heybryan.org/
1 512 203 0507

[Jeswin]

On Wed, Nov 27, 2013 at 3:28 PM, Bryan Bishop <kan...@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?

[Daniel C.]

On Thu, Nov 28, 2013 at 4:05 PM, Jeswin <phill...@gmail.com> wrote:

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?

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

[Cathal Garvey]

Aye, that'd be my idea, too. It's abhorrent to suggest that people
should be locked out of their own genomes, but it's irresponsible to
suggest that someone should be allowed to tell *others* what their
genetic fate is without any responsibility for the consequences.

Data is not diagnosis; I can tell someone "you look pale, you might be
anaemic", and that's not a diagnosis, it's merely data; particularly
if suffixed with "you should see a doctor/qualified nutritionist". If I
offer a service where people send me selfies and I tell them whether or
not they *are* anaemic, then I (in a hypothetical scenario where I'm
under their auspices) deserve the FDA's ire.

[Jordan Miller]

no one would advocate for an early pregnancy test on the market that
can give a result 3 weeks earlier but comes with a 40% error rate. it
sounds like 23andMe did not adequately quantify their error rates or
prove their science according to FDA standards.

also, please don't misconstrue "genomic data" as automagically
factual. Sample prep and readout thresholds make a big difference,
amongst other sources of error. are they doing samples in triplicate?
are they doing 10 runs per gene fingerprint? are they just doing one?
what are their positive and negative controls and how often are they
run? I don't think anyone knows what their protocols are or how they
do QA/QC.

these are just growing pains of a new industry. it's not going to kill
23andMe, and I expect the consumer will benefit from this additional
scrutiny (though prices may increase).

jordan