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DNA Helix

23andMe in the Medical Space

February 14th, 2009 by Andrew Yates

I like 23andMe. I like to have unfettered access to all information —including my genomics —even if that means “bending” the rules. However, while the medical intentions of 23andMe were ambiguous before, BRCA and pharmacogenomic testing for statins are unambiguously medical tests. Unlike other genomic testing companies who misrepresented themselves as endorsed by the medical community — 23andMe pretended no such endorsement. I liked that. I like honest rule breakers when the rules are wrong.

But now…

I sure as hell hope that the people at 23andMe know something that I don’t, because this looks to me like an excuse to call down the federal ban hammer, and what a shame that would be simply because a few people in Mountain View didn’t bother to file some paperwork. Surely, 23andMe has access to the political will, talent, and funding to secure any licenses if they chose to, so this is a deliberate attempt to push the rules.

Well, I’m going to hold on my opinion, other than state that while I eagerly anticipate the application of genomic sequences in health care, I don’t know how 23andMe expects to be integrated into medicine when 23andMe’s terms of service clearly state that it is NOT to be integrated into medicine. I suppose some other company will eat that lunch? Who knows.

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    I remain very confused about your opinion on DTC in general, and 23andme in particular. Why don't you make a post outlining, exactly, what your views are, and what you think DTC companies should do specifically?


    - What "paperwork" should 23andme file?

    - What "licences" should they obtain?

    - Should people be allowed to order "non-medical tests" that can nonetheless reveal medical information, without going through a doctor?

    - If a company wants to offer a cheap novelty product (eg: DNA, fingerprint, or blood tests), but doesn't want to run it's labs to medical / FBI / courtroom standards, what kind of legal disclaimer should it have?

    - Why are the BRCA or statin tests necessarily "medical tests"? 23andme's position is basically: "These are tests for the curious. You cannot act medically on them. If you have health concerns, talk to your doctor and get yourself tested again by a real medical lab." Why is this not a legitimate position in your view?
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    I'll respond to this more thoroughly later this week. I do have a Q/A about 23andMe from a few weeks ago:
    http://www.thinkgene.com/if-somebody-came-to-yo...

    The honest truth is that I'm still forming my opinions.
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    Why should you ever have to retest DNA?
    CLIA certification is a start, NYS and Ca State registration is a plus, ISO certification is even better.

    Some states allow patients to order medical tests, some don't. Why not just call these few SNPs what they are, medical tests and let the law decide who orders what?

    The disclaimer should read:" We are running a cheap knock off production and charging you entirely too much for it. In addition we are stealing your data and selling to the highest bidder. If you STILL want to use us rather than have your data safely protected from others looking to obtain your data...Heck, sign on up and join the conversation"

    This is a clear move towards Clinical Applicability, stop fooling yourself.

    -Steve
    www.thegenesherpa.blogspot.com
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    You should retest DNA because the test could be wrong! Contamination, untrained personnel, software errors, hackers, etc. But a company is allowed to offer a cheap novelty grade test and let others charge more for "certain enough to be actionable" tests.

    My Casio says "not for use in diving", even though everyone knows it is waterproof to 100m. I use it when I snorkel. But when I dive, I pay extra for the SCUBA certified equipment. Should Casio be banned from making waterproof watches?

    Your claim that 23andme is stealing data is (1) false, since their terms of consent are clearly spelled out; and (2) slanderous.

    Your claim that they are charging too much is interesting. How much would YOU charge me to get the same tests and detailed background info I got from 23andme?

    Face it: more people are interested in DTC companies' services than yours. Your attempt to use the government to prevent people from cheaply accessing their genetic data is unethical. YOU don't get to decide if I am allowed to access my OWN data.
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    Ouch,
    I have never stated that 23andME should be represented by this disclaimer I suggested.

    DNA retesting should not be prompted by whether the first test was cheap or not. It should be guided by how well do you trust the labs results. If the test results are not to be trusted, then even the public should not place their trust in them. Most tests are reliable.

    As for your right to know your DNA......sure. But does a company have the ability to give you a clinical interpretation without accepting regulations THAT WE ALL HAVE TO ABIDE BY when we give clinical interpretation????

    What is clinical interpretation? Descriptions which MAY be interpreted by the average person as able to be used for healthcare guidance. Plain and simple.

    Have your As, Gs, Cs and Ts.......just skip the interpretation and my argument will be destroyed.

    -Steve

    www.thegenesherpa.blogspot.com
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    I sure as hell hope that the people at 23andMe know something that I don’t, because this looks to me like an excuse to call down the federal ban hammer
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    Hi. A search about 23andme led me to this blog post. I'm thinking of getting a DNA test done with them. I've read that Google was one of the companies that invested in 23andme so I'm thinking maybe they're a reliable group, but I'd like to know what happened to 23andme a year ago? This post is unclear.

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