

23andMe Provides An Update Regarding FDA’s Review - peyton
http://admin.blog.23andme.com/news/23andme-provides-an-update-regarding-fdas-review/

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mikkelewis
_As we work with the FDA to get clearance, there will be some significant
changes to the site. Customers who purchased kits on or after the FDA’s
warning letter of November 22nd will not have access to health-related
results. Those customers will have access to ancestry-related genetic
information and their raw data without 23andMe’s interpretation of that data.
They may receive health-related results in the future, depending on FDA
marketing authorization._

This paragraph is by far the most disappointing with regards to the short-
medium term future of 23andMe.

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tokenadult
"23andMe will comply with the FDA’s directive and stop offering new consumers
access to health-related genetic tests while the company moves forward with
the agency’s regulatory review 23andMe_Logo_blogprocesses."

And that means 23andMe can't follow its business model of crowd-sourcing lots
of personal genomic and medical history data to number-crunch its way into
having actual information to offer consumers years after they have paid to
send their DNA to 23andMe.[1] That plan looked clever to some investors just a
while ago, but now investors are finding out that 23andMe is clueless at the
top, and trying to make its way in a heavily regulated industry for which the
regulator is not about to cave in to cute marketing campaigns.

After it announces its service changes, the company lets us know, "This is
clearly a much different service than in the past, so we are offering
customers who purchased kits on or after November 22, 2013 a full refund if
they wish. Those customers will get an email from 23andMe with details on the
refund policy. Eligible customers who do not receive an email are encouraged
to check their spam email folders for the email with their personalized
instructions or contact our Customer Care Team."

A funny detail is that the blog post on the company blog itself has an ad
linking to signing up to send in DNA for $99 from the DNA donor, but following
the link leads to an announcement that the company is out of that business for
a while.

[1] [http://www.fastcompany.com/3018598/for-99-this-ceo-can-
tell-...](http://www.fastcompany.com/3018598/for-99-this-ceo-can-tell-you-
what-might-kill-you-inside-23andme-founder-anne-wojcickis-dna-r)

~~~
ljd
Maybe you haven't seen what "clueless at the top" looks like.

It doesn't look like a successful company that's torn down by heavy handed
regulators.

~~~
tokenadult
What's successful about 23andMe so far? (I'm asking genuinely, as the company
is new, and I wonder what the benchmark for success that you have in mind is.)

~~~
ljd
That's a fair question.

They created a product/service that people willingly pay for and they do it on
a large scale.

A clueless company looks like the guy that sent me a kickstarter link last
week with copy that says, "The Next Big Thing" and it was a photo sharing
application.

The leadership from Exhibit A tend to build companies like Google, McDonald's
and Walgreens. You would have to be daft to consider them clueless.

The leadership from Exhibit B don't build anything of significance but do
occasionally luck out, reinforcing a massive selection bias that fuels the
next 100 startups that are just like it.

I just think that rhetoric is important on a site like HN. Calling someone
clueless that did what we all want to do with our own endeavors seems pretty
harsh. I know I personally feel for the management team tonight. It has to be
hard to spend so many years building something great only to be smashed down
by regulators.

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Fr0styMatt
I feel really sorry for them too, but from the FDA's letter I got the
impression that 23andMe just stopped working with the regulator altogether,
even though they were given the opportunity to do so. If that is the case,
that's really what I don't understand.

Bummer, I was almost ready to order one of the kits. Would have been
fascinating.

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dustyreagan
I downloaded my raw data and took screenshots of my results just in case they
get shut down. :(

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ljd
I think this means I can scalp my pre-Nov 22nd, unused kit.

All kidding aside, this is pretty disappointing. I bought one for myself a
year ago and it was a life altering experience. I know that 23andMe have come
under scrutiny with regards to not only the accuracy of their findings but the
manner in how they communicate it but I have not had problems with either.

I hope the FDA allows this company to continue what they are doing. It's rare
that such an opportunity exists for the layman to understand their genetics.

EDIT: I've verified the more dramatic findings outside of 23andMe. I never saw
23andMe as an authoritative source, but it is a great guide.

~~~
auctiontheory
It's only life-altering (in a good way) if the analysis 23andMe sent you was
accurate, and many professionals in the field of the genetics say that it
often is not. You say you haven't had problems with the accuracy of their
findings, but unless you've had the test repeated by a research university,
I'm not sure how you'd know.

Don't get me wrong - I want all this data for myself - but I don't want to be
misled or falsely worried.

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baddox
Well, that's ridiculous. I just bought a kit two days ago. I wonder if I
should send the kit back _then_ ask for the refund, or just send the kit back
unused.

