

An Update Regarding The FDA’s Letter to 23andMe - loopasam
http://blog.23andme.com/news/an-update-regarding-the-fdas-letter-to-23andme/

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loopasam
Original text, the blog seems down:

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

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SpikeDad
The FDA has bent over backwards - pretty much everything that 23andMe needs to
do in order to sell legally has been laid out, and ignored.

The Google egotistic approach is well ensconced in 23andme

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logjam
That's not an "update" \- it's corporate bullshit that says nothing.

23andMe is _finally_ learning that there are actual, legitimate reasons why
regulations exist around medical testing.

Off topic: when did the smarmy cliche "reach out to you" become the ubiquitous
way to say "contact you"?

