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California Cracks Down On Genetic Testing
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.
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.
Tic-Tac-Toe, Global Thermonuclear War, and relationships all have the same winning move.
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.
The world's burning. Moped Jesus spotted on I50. Details at 11.
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.
[insert generic slashdot meme]
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. 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.
'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/
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?