

Sergey's wife has a bad day: ordered to shut down by State Health officials - gscott
http://news.cnet.com/8301-10784_3-9971383-7.html

======
Zak
_They also must show that tests ordered on their sites have been at the
request of a doctor, as required by state law_

Does anyone else find this to be an absurd intrusion of the government in to
the rights of individuals to learn about their own medical conditions? For
those of you who live there, rumor has it, California has a pretty effective
voter refferendum system....

~~~
timr
It's really not absurd.

The problem with these tests is that they can be extremely difficult to
interpret, tricky to run correctly, and bad/incorrect results can easily lead
to drastic consequences (i.e. expensive follow-up tests and procedures).

These companies are effectively selling medical equipment, but so far, they've
side-stepped the usual regulations by selling direct-to-consumer. It was
inevitable that this situation would change.

~~~
natrius
If I think I can interpret them correctly, I should be allowed to get the
tests done, regardless of what the government thinks about it. Stick a
disclaimer on them if you must, but prohibiting the request of such tests by
laypeople is fundamentally illiberal.

~~~
timr
It's not just the interpretation that's important. Medical tests are carefully
regulated and tested to ensure that they're accurate. These "tests" are not.

In other words, this argument gets filed in the same bin as those that would
suggest that FDA regulation of food and drugs is overbearing, and that we
should all be allowed to eat whatever we want. It goes beyond personal choice;
it's a matter of public health.

~~~
jey
OK, so legislate the need for accuracy through licensing, etc -- I don't see
how a doctor's order would make the test more accurate.

~~~
timr
Part of the problem is that these tests aren't for specific diseases, and
really _can't_ be made more accurate. Nobody knows what these genetic
association studies mean on a clinical level.

For example, if a woman is found to have a SNP marker that is associated with
breast cancer, you might conclude that she shouldn't take birth control, since
that raises the risk. But what if she _also_ has a marker associated with
ovarian cancer? Hormone therapy helps with that. What then? There are dozens
of stories like this one, and even doctors are over their heads when it comes
to this stuff. There's absolutely no chance that a layperson is going to be
able to interpret the data of such a clinically dubious test.

It may not be the best idea to enforce a doctor's order for these things, but
there's a legitimate argument to be made, and it goes well beyond a simplistic
interpretation of personal liberty. If enough people shell out for these
scans, it's going to cause panic, over-medication and over-utilization of the
medical system. Again, it's a question of public health.

But don't take my word for it...here's a great editorial with some even better
examples of the problems:

[http://seattletimes.nwsource.com/html/opinion/2004425391_gen...](http://seattletimes.nwsource.com/html/opinion/2004425391_geneticsop20.html)

~~~
Zak
The tests for various SNP markers can be verified as accurate or not. The
interpretation of the presence of a given marker may be up for debate, and
these companies should not be making exaggerated claims about the ability of
these tests to predict a person's risks for specific diseases.

In short, if something should be regulated here, it's the claims these
companies make about the value of the tests.

~~~
rms
They make little or no claim about the value of the tests. The argument
against what they are doing is saying that offering _any_ information about
disease risk is an inherently medical topic.

------
DaniFong
This headline irks me. Anne Wojcicki isn't just "Sergey's wife", 23andme isn't
just Anne Wojcicki, and they weren't ordered to shut down, just to hold their
tests while officials investigate.

------
rms
<http://thegenesherpa.blogspot.com/> has the best coverage on this issue, in
my opinion

~~~
bbgm
Unfortunately, Steve has it all wrong. I appreciate his point of view, but his
proposed solutions are just not right. To me, this move smells of lobbyists. I
like Tom Goetz' response

[http://blog.wired.com/wiredscience/2008/06/attention-
calif.h...](http://blog.wired.com/wiredscience/2008/06/attention-calif.html)

~~~
rms
Steve takes it to an extreme conclusion, but I think whether he is right or
wrong, his ideas are ultimately going to be carved into legislation.

Right now the bigger problem is education about genetic testing and genomics.
There is a lot of work to be done in this space.

23andme and Navigenics provide reasonable informational genetic testing. But
they are only so useful because they purposely avoid testing for high
penetrance mutations. [http://www.thinkgene.com/absence-of-high-penatrance-in-
snp-g...](http://www.thinkgene.com/absence-of-high-penatrance-in-snp-genomic-
services/) High penetrance tests are the ones that are really medically
important, and in the coming years of genomic medicine, Navigenics and 23andMe
can only get so far without high penetrance tests. Unfortunately most of the
high-penetrance tests are patented, but the patents will be gone by the time
everyone can afford a real genome scan.

If you've had a 23andme test, you can actually dump the raw data and check
yourself for some patented high penetrance genes.
[http://www.thinkgene.com/tell-me-everything-how-to-use-
snped...](http://www.thinkgene.com/tell-me-everything-how-to-use-snpedia-
for-23andme-and-decodeme/)

~~~
bbgm
I believe 23andme uses the Illumina marker panel + some additional custom
markers.

First of all a diagnostic array will almost never be a high throughput array.
Illumina doesn't market its 550K or 1M chips for diagnostics. The diagnostic
assay will use something like beadxpress or other targeted chip. The business
model is one of providing information, that's it. If that's going to be
regulated, the only regulation should be in ensuring CLIA facilities, and
making sure that the companies do not offer services that might make patients
think that they were providing a diagnosis (Navigenics is the one I worry
about here).

Having been directly involved in this space over the years, it's clear that a
lot of work is needed, and even if we knew about disease causing SNPs and had
high risk factors, we really don't have the drugs that are married to any
diagnostics yet (with exceptions), but that shouldn't stop us from getting
access to the information, especially since the costs pretty much act as a
barrier at this time.

------
gojomo
Despicable Valleywag-like headline, hiding an interesting story.

23andMe and a dozen other California-based genetic testing services are
affected. They might be able to resume sales in a few weeks. Also, California
law apparently requires such DNA tests to be ordered by a doctor.

------
babo
Were you a tabloid news editor in your previous life? :-)

