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Biotech Your Rights Online

California Cracks Down On Genetic Testing 165

Posted by kdawson
from the first-salvo-in-a-long-campaign dept.
genie-out-of-the-bottle writes "California's Department of Public Health has sent cease-and-desist notices to 13 companies that market genetic testing directly to consumers. (We discussed these services when they launched.) Allegedly, under state law, California residents must submit a doctor's order to have a genetic test run. It will be interesting to see if the government will actually succeed in putting the genetic genie back in the bottle, given that all you need for testing is a few drops of saliva. The effort closely resembles US government attempts to block export of strong encryption product back in '90s." A Wired editor has up an opinion piece arguing that his DNA is his business and none of the government's.
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California Cracks Down On Genetic Testing

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  • by oodaloop (1229816) on Tuesday June 17, 2008 @04:54PM (#23829927)
    Patenting DNA was a problem maybe 10 or so years ago, but since then much of the patents and patentable information on DNA has been collected in open repositories of information. Drug companies have found it much more lucrative to open up this information and share it with other companies rather than keep it to themselves - shouldn't be too surprising to open-source enthusiasts. Instead, they have been concentrating on deriving income further downstream from the drugs produced from the DNA data. Right now, most of your DNA is open-source.
  • by MightyMartian (840721) on Tuesday June 17, 2008 @05:01PM (#23830075) Journal
    The issue is that these companies did not create the DNA. It was yet another abuse of the patent system, and the courts and the government didn't have the balls to ban it outright. If it ain't an invention, it shouldn't be patentable.
  • by sammaverick (771437) on Tuesday June 17, 2008 @05:06PM (#23830183)
    California requires a doctor's order form for not just genetic testing. The company I work for (www.biophysicalcorp.com)(is it kosher for me the link my company here?) does direct-to-consumer blood/ biomarker testing, and for California and about 9 other states, the individual consumer can not just order the test from us, they have to have their doctor sign a order form (Which creates a hassle for us and the client).

    Heck, in a few states (Cali included) we can't even send the client their report, we have to send it to the doctor's office.

    I am pretty sure this law is in effect partially to protect the interests of the doctors in general.
  • by commodoresloat (172735) * on Tuesday June 17, 2008 @06:13PM (#23831279)
    I heard that they will pass over your infringement if you post some of your DNA over your front door... Just put some blood on the door and you will be spared the C&D!
  • by WaltBusterkeys (1156557) * on Tuesday June 17, 2008 @06:17PM (#23831315)
    It's a pretty common misperception that somehow humans would have to pay license fees for use of DNA.

    What was being patented was a purified sequence of DNA for use in a diagnostic test. It's not the DNA itself--there's 10 million years of prior art for that--but the use of a particular sequence of DNA for diagnostics.

    The total human genome is over 3 billion base pairs. Companies were racing to figure out which small sequences (100 or so pairs) would be useful in diagnostics and possibly in therapy. The use of DNA for that purpose was completely new at the time.

    For example, check out this DNA patent application [uspto.gov]. The application refers to a specific DNA sequence, but the patent itself is for the use of that particular sequence for a specific kind of therapy.

    It's still perfectly legal to reproduce, sell your DNA in a bottle, and so forth. The only thing the patent covers is the use of one very short sequence in a particular kind of therapy.

    It might still be bad policy, but it's not as if you don't own your DNA.
  • by garett_spencley (193892) on Tuesday June 17, 2008 @07:03PM (#23831887) Journal
    I don't think you understand what patents are and how they work.

    There are 3 types of patents:

    Utility Patent - protects the way that your "invention" is used and works. Your "invention" does not have to be a machine or something tangible. It can be a business method or a process of doing something. For example, you can patent a method for making a pepperoni pizza so long as your method is novel. You did not have to have invented pepperoni pizza.

    Design Patent - protects the way something looks. I'm not 100% clear on this but I assume that this is different from copyright law in that it can cover the ornamental appearance of a tangible invention. To make further use of my pepperoni pizza example, you could file a design patent on the way your pizza looks so long as no other pepperoni pizzas invented prior looks the same etc. I'm sure that car companies get design patents all the time on the appearances of their vehicles.

    Planet Patent - government grant given to people who discover or invent new asexually reproducing plants and lasts for 20 years. Very simplified explanation, read more at http://smallbusiness.findlaw.com/patent/patent-types/plant-patents.html [findlaw.com] if you're interested.

    From what I gathered from the GP (I'm going by my interpretation of what he said, I'm not familiar with the patents themselves), the case in question was a patent on a METHOD for using specific gene sequences in a form of therapy. They weren't patenting the DNA itself.
  • by stranger_to_himself (1132241) on Tuesday June 17, 2008 @07:34PM (#23832293) Journal

    Do you have any actual data that backs this up?

    The US Government Accountability Office compiled a report of genetic testing that is available here [gao.gov], although it's only a smallish snapshot of the current situation.

    Both the positive and negative implications for widespread genetic testing are favourite subjects of Ron Zimmern and Muin Khoury, and if you're interested you'll find a lot of discussion of genetic test regulation by searching for them. There's a newspaper report of a study by Khoury here [guardian.co.uk], but annoyingly I can't find the original work.

  • by RDW (41497) on Tuesday June 17, 2008 @08:00PM (#23832613)
    'I don't know anything about California, but it could be that the government is trying to protect people from possible harms of bad and unnecessary testing.'

    The interesting thing is that this technology is evolving so rapidly that the type of testing California is cracking down on is going to look quaintly prehistoric in just a few years. Roche is expected to launch a commercial high resolution version of its 'sequence capture' platform in the next few months which, combined with a 'next generation' sequencing system (like Roche's own 454 machine), should allow complete human 'exomes' (all the well-defined mature gene transcript sequences in a sample) to be completely sequenced for a few thousand dollars. But this, of course, is just the first step. One or more of the future sequencing technologies currently in development is likely to bring entire human genome sequences into this price range:

    http://genomics.xprize.org/ [xprize.org]

    with the eventual Holy Grail of a '$1000 genome' now seeming pretty much inevitable. But some of the teams competing for the genomics X-prize don't intend to stop there - e.g., Reveo claims to be aiming to produce a practical nanotechnology-based instrument 'in 5-10 years that will cost less than $1000 and sequence the whole genome and simultaneously the epigenome (methylation code) nearly error free in a minute for pennies per genome.'

    So what happens if it's possible to buy an extreme throughput sequencer for the price of a laptop, and decode a genome as effortlessly as cracking CSS on a DVD? Is this particular genie really likely to stay in the bottle? And is it in any case defensible that knowledge of an individual's genome should ('for his own good') remain the province of an exclusive medical priesthood, rather than of the individual himself?
  • by mveloso (325617) on Tuesday June 17, 2008 @09:37PM (#23833507)
    Interesting study!

    "To complete our work, we investigated a nonrepresentative selection of four Web sites selling nutrigenetic tests.

    What's amusing is that they only had two DNA samples, from a 9-month old girl and a 48-year old man...but they submitted them 16 times to four separate sites with different profile information.

    The short of it is: the four sites in question seem to base their results off of your profile questions, not your DNA. In addition, they attempt to cross-sell supplements to you.

    I wish they had done more than 4 sites, but maybe that's all they could find back in 2006.

"Consequences, Schmonsequences, as long as I'm rich." -- "Ali Baba Bunny" [1957, Chuck Jones]

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