4 ms·

Sergey's wife has a bad day: ordered to shut down by State Health officials

16 points by gscott 18y ago

gojomo 18y ago
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.
Zak 18y ago
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....
- deleted 18y ago
  [deleted]
- timr 18y ago
  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 18y ago
    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 18y ago
      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 18y ago
        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 18y ago
        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_geneticsop20.html http://seattletimes.nwsource.com/html/opinion/2004425391_gen...
        Zak 18y ago
        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 18y ago
http://thegenesherpa.blogspot.com/ http://thegenesherpa.blogspot.com/ has the best coverage on this issue, in my opinion
- bbgm 18y ago
  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.html http://blog.wired.com/wiredscience/2008/06/attention-calif.h...
  - rms 18y ago
    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-genomic-services/ http://www.thinkgene.com/absence-of-high-penatrance-in-snp-g... 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-snpedia-for-23andme-and-decodeme/ http://www.thinkgene.com/tell-me-everything-how-to-use-snped...
    - bbgm 18y ago
      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.
babo 18y ago
Were you a tabloid news editor in your previous life? :-)
DaniFong 18y ago
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.

16 points by gscott 18y ago

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.

Zak 18y ago

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....

deleted 18y ago
[deleted]
timr 18y ago
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 18y ago
  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 18y ago
    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 18y ago
      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 18y ago
        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_geneticsop20.html http://seattletimes.nwsource.com/html/opinion/2004425391_gen...
        Zak 18y ago
        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 18y ago

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

bbgm 18y ago
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.html http://blog.wired.com/wiredscience/2008/06/attention-calif.h...
- rms 18y ago
  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-genomic-services/ http://www.thinkgene.com/absence-of-high-penatrance-in-snp-g... 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-snpedia-for-23andme-and-decodeme/ http://www.thinkgene.com/tell-me-everything-how-to-use-snped...
  - bbgm 18y ago
    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.

babo 18y ago

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

DaniFong 18y ago

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.