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Genetic Companies in Trouble in California

Months before, Steve and I, we both said it would happen. And now look at this announcement:

The California Department of Public Health has issued notices to 13 laboratories to cease and desist performing genetic testing for California residents until the laboratories meet the requirements specified in state law.  Any laboratory offering genetic tests to California residents must be licensed as a clinical laboratory in California. The tests must be ordered by a licensed physician and validated.  Tests for paternity and genealogy are not subject to these laws.

Just an example from one of the letters:

23andMe must immediately Cease and Desist offering genetic tests to citizens of California until a license has been issued by the Department. Any advertising for genetic services, whether it be in written word or by internet, must clearly state that this testing is prohibited for California residents. 23andMe shall not take any unsolicited requests for genetic tests from California residents.

Genetic tests are not funny or interesting products, but tools in the hands of qualified physicians who know what genomic medicine is about.

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7 Comments Post a comment
  1. Berci,
    It’s funny how we talked about these things way before the Big 3 ever came into existence. It think that DTC will have to morph. I imagine that they will now have to get into the physician education realm……I am certain that will be their next foray!!

    Take Care
    -Steve

    July 3, 2008
  2. Why would a physician even want to be involved in the decision whether someone should get an SNP profile? Isn’t this more the job of the FDA?

    Let’s be clear here: Do we simply want the companies to be CLIA-certified and to refrain from making false promises about the results, or do we think they should only be allowed to offer their services to physicians instead of direct to consumers? If it’s really about protecting consumers, can’t they get a referral to a qualified geneticist after the test?

    July 3, 2008
  3. Steve, you knew exactly how to launch the service and chose the right way with your physician-based system.

    Mr. Gunn, this is not the job of the FDA, but the job of qualified geneticists.

    July 4, 2008
  4. Berci, I am not a qualified geneticist, nor are a few other people I know who have been genotyped. If I could afford it, I would have got myself genotyped a while ago. I don’t need a physician to tell me that. It’s basic information, about me.

    If I want to do something based on that information, absolutely, a physician will be brought in, cause I am not going to make the treatment decisions without them.

    Now lets take a look at people self-medicating after reading something about their cough and fever on WebMD, perhaps even using some antibiotics they might have lying around. Should WebMD be shut down?

    The point is this, sequence data is not a test, and in fact that is not how a diagnostic is developed. You cannot use high density microarrays for diagnostics (Illumina has the BeadXpress platform for that). So even is a physician was using those arrays to predict treatment, he/she would have to ask them to take a specific test so that the statistics and specificity are right, so lets not make things what they are not.

    July 5, 2008
  5. Deepak, you’re absolutely right about that you can request to be genotyped. It’s your genome, it’s your data. You can also request to have a CT image of you chest. That’s your body, that’s your image.

    But I believe, to make a medical decision based on these data is a job of a qualified physician.

    To know whether you produce the odorous compounds after eating asparagus or not, that’s a funny thing these companies can tell you. But to change your Coumadine dosage because of your genotyping data, that is not a decision a layman can make.

    Anyway, I think we’re saying the same. What do you think?

    July 5, 2008
  6. N/A #

    I think the point is that these companies (some of them at least) are very specifically telling you NOT to make medical decisions based on the information you are getting (from 23andMe’s website “we cannot and do not diagnose diseases or medical conditions, provide medical advice or otherwise assess your health. You should always contact your physician, a genetic counselor or other professional if you have any questions or concerns about what you learn through 23andMe”. Navigenics has something similar under their terms and conditions page).

    July 5, 2008
  7. Anonymous #

    Physicians are not geneticists until they are certified with the proper training.

    April 28, 2009

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