I just finished emailing David Ewing Duncan (Who has a great new blog) about the frustration I have. You see, everyone is saying....these SNP tests are information/data, not really medicine. But I reminded him that there were 11 others named and letter sent. It turns out our friends at Wired show that a DTC genetic testing company was named. The cease and desist letter is clear enough.
So what is DNA Traits?
From the site
DNATraits was founded on one simple idea: if science can tell us whether we carry inheritable disorders, we have the right to know, for our own health and for the future of our families.
With years of experience in genotyping for large corporations and delivery of DNA-related information to hundreds of thousands of customers, a group of scientists and entrepreneurs formed DNATraits to lead a paradigm shift in the way DNA tests related to inherited traits are made available to the general public.
This is single gene testing and bundled packages of some valid tests. So why did they receive a letter? Simple, they sold tests online. Did they offer phone counseling? Absolutely....Free
So why did they receive a letter? They sold testing online without involvement of a physician. And no clinical lab license in California. This is why Ryan is so smart. She doesn't run labs!!! This is the hook guys. If you run a lab, then you have to meet some stringent criteria. If you are the middle man...you'll be ok. Provided you work with healthcare providers.
In addition, ASH is no longer endorsing thrombophilia testing. The genetic change and risk is minimal. The family history or medical history of clots is much more telling.
You will see, the other 11 failed to meet some serious issues. As we see more of the companies named we will begin to see that there are certain benchmarks required....have been for the last 20 years. This is not new regulation guys. Some lawyer for each company dropped the ball. Or, misinterpreted the laws. Take your pick.
I hope the journalists cover this, rather than hype the "Big Brother is Gonna Getcha" model.
The Sherpa Says:
I have no beef with the big 3's ideals. They took a brave step. Their lawyers were dead wrong. But, I do have a beef with anyone who says medical interpretation of tests to indicate risk is NOT medicine. It is. I have always said this and will stand my ground.
Thursday, June 19, 2008
DNA Traits among the 13
Subscribe to:
Post Comments (Atom)
3 comments:
hmm. interesting point. I've been wondering why they left DNA Direct alone. Yes, we'll follow this up at Wired.
I would be more likely to share your view were the personal genetics companies providing solely information for diagnosis. However, there are some interesting genealogically information as well. I don't think I should have to go through a physician to determine if my ancestors came from eastern europe.
well, I'm with you on this one. I know a company that got a letter, but this is their defense (and I presume it's a good one): the company only works through doctors, does not sell tests online, agrees that looking at ANY SNPs requires the intervention and mediation of a doctor, even if its "intention" is "non medical", does not own or run a lab, and the labs that process the tests are CLIA certified. I'll keep you posted how it turns out, but at least you can see the laziness of government bureaucrats at work, when "catchall" letters go out without any attempt to figure out the "good" from the "bad"... I think public mistrust of government is often based on what a crappy job the bureaucrats do, more than people not wanting regulations in place. If you practiced medicine the way many people in the public sector perform their duties, you would lose a lot of patients.
Post a Comment