Icelandic genomics company deCODE Genetics has received a license to market direct-to-consumer genetic tests (such as the genome scan provided by daughter company deCODEme) in the state of California. This follows the regulatory crackdown by California's public health department last June, which sent nervous ripples through the direct-to-consumer genetic testing industry.
Personal genomics rivals 23andMe and Navigenics both received their own licenses last August, and it's unclear to me why it's taken so long for deCODEme to follow suit (please feel free to speculate wildly in the comments).
In the press release, notoriously gruff deCODE CEO Kari Stefansson (pictured above) can't resist a dig at his competitors:
Our competitors outsource the science, the DNA-analysis, or both. But
for us this is the real foundation of personalized medicine, and we are
committed to delivering only the best validated tests and the highest quality
results, all in-house.
The fact that deCODE performs its own (extremely high-quality) genetic research has always been the major point that deCODEme has tried to emphasise in the war to differentiate itself from its rivals. However, I don't think it's likely to be a major issue for the average consumer, who's typically only interested in whether a personal genomics provider can explain the meaning of their genetic data in a clear, simple and accurate manner - something that generally seems to be done better by 23andMe.
23andMe doesn't seem to have any trouble taking deCODE's results and converting them into useful product for their own customers - in fact, one of the nerdier ways I sometimes amuse myself is to count the proportion of genetic associations featured on 23andMe's blog The Spittoon that were generated by deCODE's scientists (at the current time, 3 out of 10 posts on the front page feature deCODE's work). I somehow suspect this game would strike Stefansson as less than hilarious.
(Hat tip: GenomeWeb.)
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more like HEYme2...
It's great that deCODEme does science work. I encourage them. But as a consumer, it's of little value to me because most results will in any case be obtained by outside parties (NIH, university labs, etc.).
So the real value comes in
(1) Providing a platform that allows me to test my genes without getting a doctor's authorization and
(2) Providing clear and concise analysis of the research data that's out there.
I don't have time to read through and track all the studies myself to see which were done well, which have been replicated or discredited, etc.
There is little evidence for a need for regulation of legitimate personal genomics companies.
Labcorp will probably clone the winning company's formula or buy them out. They'll have clout to wave the lawyers off. Fat cat venture cap money right now would love to scare off competitors by erecting nonsense barriers to entry.
The markets and maybe fraud statutes can sort this one out.
Let 'em play.
@ Anomalous
I agree, let them play.....on the same field as Monogram biosciences or as any other CLIA, CAP, NYS, ISO, approved diagnostic lab in the country......
A medical test IS a medical test.....BRCA testing IS medical testing.....to state otherwise is pretending you are arguing over what the meaning of the word "Is" is......
-Steve
www.thegenesherpa.blogspot.com
@ Daniel,
So you only discovered 30% of what these other companies sell as if it's their own.........Hasn't Kari heard of Myriad before? Tsk....Tsk......you snooze, you lose buddy.
-Steve
p.s. At least Kari is actually TRYING to create clinically usefuls tests, not Denying that he is.....
Of course he's p***...upset. Especially when Time magazine nominated 23andme as "invention of the year" - "stolen invention of the year" according to decode, and not without some justification...has he ever been invited to as spit party i wonder? I expect he would like to find some inventive things to do with the contents of the spitoon.
Keith