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23andme has suspended health-related genetic tests
31–40 of 68 posts
Re: 23andme has suspended health-related genetic tests
#32If you think that's dumb, here are a couple of petitions you can sign: http://www.change.org/petitions/fda-administrator-margaret-h... https://petitions.whitehouse.gov/petition/overrule-fdas-deci...
I think those petitions are highly dubious. Neither of them accurately references the FDA's issue with 23AM.
> highly dubious
See: most things on Change.org.
Re: 23andme has suspended health-related genetic tests
#33We can learn a bit more about this dispute from how 23andMe has responded here. Given that 23andMe is still willing to release their raw genotype results, it seems clear that the FDA isn't objecting to that level of their work. That's comforting: evidently at least that is considered more or less accurate. Instead, they've only redacted "23andMe’s interpretation" of the data from their reports to new customers. My ta…
I agree - Here's a company that built a complex software system, loaded it with "if" statements pulled from research papers, and started marketing itself as a predictor of cancer and disease. How did they do their research? What is their threshold for determining if scientific evidence is conclusive enough to merit telling the world they could have a major disease? The FDA wants to know, and so do I.
Re: 23andme has suspended health-related genetic tests
#34We can learn a bit more about this dispute from how 23andMe has responded here. Given that 23andMe is still willing to release their raw genotype results, it seems clear that the FDA isn't objecting to that level of their work. That's comforting: evidently at least that is considered more or less accurate. Instead, they've only redacted "23andMe’s interpretation" of the data from their reports to new customers. My ta…
I agree - Here's a company that built a complex software system, loaded it with "if" statements pulled from research papers, and started marketing itself as a predictor of cancer and disease. How did they do their research? What is their threshold for determining if scientific evidence is conclusive enough to merit telling the world they could have a major disease? The FDA wants to know, and so do I.
So now, people will just export their data and third party companies will provide such interpretation and the FDA won't be able to touch them. How soon until github has an open source project to read and interpret 23andme data-dumps?
Re: 23andme has suspended health-related genetic tests
#35Earlier quoted context omitted.
I don't see how the results could be harmful or negative. My highest risk item was a 54% chance of Type 2 Diabetes. It's interesting information, but I'm not making any huge life decisions based on it..
Why haven't you made any huge life decisions based on it? Wasn't that the point of you ordering the test? If you do strenuous exercise several times a week and adopt a healthy diet, your risk will drop dramatically. Was it because you already do these things?
I got this test too, but it didn't show any terrifying results.
I wanted to know if I have awesome genetic material and it was true ;)
Re: 23andme has suspended health-related genetic tests
#36We can learn a bit more about this dispute from how 23andMe has responded here. Given that 23andMe is still willing to release their raw genotype results, it seems clear that the FDA isn't objecting to that level of their work. That's comforting: evidently at least that is considered more or less accurate. Instead, they've only redacted "23andMe’s interpretation" of the data from their reports to new customers. My ta…
That's comforting: evidently at least that is considered more or less accurate.
I'm not sure you can safely draw that conclusion from the way this has played out. I think it's equally, if not more likely, that 23andMe is able to continue offering raw and ancestry data simply because those things are outside the FDA's purview.
Consider, by analogy, the dietary supplement industry: the FDA has incredibly more power over a product that is advertised or marketed as intended to "diagnose, treat, or cure any disease." Notice how the manufacturer explicitly disclaims that exact verbiage on all those sorts of products? That's because anything that is marketed that way is immediately subject to a much higher degree of FDA jurisdiction, under which they can literally shut you down overnight.
When 23andMe runs your genome and sees a genotypic match for an arbitrary disease, and then tells you that you have that disease, they're diagnosing you. When they tell you that you're 72.3% Northern European, or give you a ginormous CSV (or however they encode their data dumps), they aren't.
That's the only thing I think you can meaningfully read from this situation: they're changing the way their product is marketed, and the services they provide, so as not to be subject to the FDA's nuclear option.
Re: 23andme has suspended health-related genetic tests
#37We can learn a bit more about this dispute from how 23andMe has responded here. Given that 23andMe is still willing to release their raw genotype results, it seems clear that the FDA isn't objecting to that level of their work. That's comforting: evidently at least that is considered more or less accurate. Instead, they've only redacted "23andMe’s interpretation" of the data from their reports to new customers. My ta…
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Re: 23andme has suspended health-related genetic tests
#38Government, once again, deciding they know what is best for you. I really hope people are paying attention and vote with their intelligence during the next several elections. We need less government. Everywhere. Not more.
Or they could have worked with the FDA which it appears they were more than willing to do (FDA that is).
But fuck it. Libertarian nerd rage. Disrupt!! There is a reason people outside your bubble think you are assholes.
Re: 23andme has suspended health-related genetic tests
#39I am wondering, what about foreigners? Is it possible to get the full test and analysis if the results are shipped to, say, Europe, or is it locked for us too?
European regulation is supposed to be harsher than US one, so it is highly unlikely, but I didn't found the information on the website.
Re: 23andme has suspended health-related genetic tests
#40This seems to be the nuclear option. As a (now fortunate) previous purchaser of 23andme, I still have my health information. The information is really valuable, and considering the price ($99!) it is cheaper than a lot of standard medical exams and bloodwork. Obviously not a replacement for any of those things, but it's amazing they can offer DNA health results for so little. The FDA seems to be mostly concerned that…
I agree. Trying noninvasive but inaccurate tests before accurate but invasive tests is just par for the course. 23andMe is certainly noninvasive, and as far as I can tell more accurate than most such preliminary tests.
The accuracy isn't the problem. It's that the accuracy is unknown. And evidently 23adMe haven't been attempting to prove it to the FDA.
As far as I'm concerned at that stage you might as well take homeopathy.
> and as far as I can tell more accurate than most such preliminary tests.
Oh thats good? I'm sure that anecdotal well set the FDA at ease.