Re: [DIYbio] Text of 23andme email

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



> On Nov 28, 2013, at 7:44 PM, Cathal Garvey <cathalgarvey@cathalgarvey.me> wrote:
>
> 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.
>
> On Thu, 28 Nov 2013 17:31:35 -0700
> "Daniel C." <dcrookston@gmail.com> wrote:
>
>>> 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
>>> 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
>

--
-- You received this message because you are subscribed to the Google Groups DIYbio group. To post to this group, send email to diybio@googlegroups.com. To unsubscribe from this group, send email to diybio+unsubscribe@googlegroups.com. For more options, visit this group at https://groups.google.com/d/forum/diybio?hl=en
Learn more at www.diybio.org
---
You received this message because you are subscribed to the Google Groups "DIYbio" group.
To unsubscribe from this group and stop receiving emails from it, send an email to diybio+unsubscribe@googlegroups.com.
To post to this group, send email to diybio@googlegroups.com.
Visit this group at http://groups.google.com/group/diybio.
To view this discussion on the web visit https://groups.google.com/d/msgid/diybio/6882645196875951302%40unknownmsgid.
For more options, visit https://groups.google.com/groups/opt_out.