This 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.<p>The FDA seems to be mostly concerned that the results of 23andme could be misinterpreted, or wrong. As far as I am aware, 23andme was advertising the health assessment as the first step in prevention - not a one stop shop for diagnosis. I am not very impressed with the FDA.
We can learn a bit more about this dispute from how 23andMe has responded here.<p>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.<p>Instead, they've only redacted "23andMe’s interpretation" of the data from their reports to new customers. My take on this is that the FDA wants some sort of rigorous demonstration that 23andMe isn't making errors in its interpretation of medical data. I'm thinking specifically of stories like this one: "My deadly disease was just a 23andme bug" <a href="https://news.ycombinator.com/item?id=6796219" rel="nofollow">https://news.ycombinator.com/item?id=6796219</a> It's hard to know (as a simple consumer) how common that sort of error might be: I rely on folks like the FDA to set and enforce quality standards on such things.<p>Similarly, I honestly don't have a great sense of how well 23andMe's interpretations reflected the full current state of known science. For instance, my memory is that they were only able to test for a few of the known breast cancer risk factor genes because others are still covered by patents. How clearly did their interpretation pages convey those gaps in what they were presenting?<p>I hope that 23andMe finds a way to get fully back online before long. But honestly, I'd be happiest if they manage to satisfy the regulators that they really are getting things right. <i>Someone</i> needs to verify claims like that for the rest of us!
Since they are discontinuing their interpretation of the data, they should just open source the interpretation engine and dataset. People still have to pay the $99 for the tests to get the data to interpret, so it wouldn't harm their business. It would keep their service out of the FDA's crosshairs, while keeping the service as useful as ever. In fact, it would likely improve it over what it will become with this latest development.
If you think that's dumb, here are a couple of petitions you can sign:<p><a href="http://www.change.org/petitions/fda-administrator-margaret-hamburg-don-t-ban-home-genomics-kits" rel="nofollow">http://www.change.org/petitions/fda-administrator-margaret-h...</a><p><a href="https://petitions.whitehouse.gov/petition/overrule-fdas-decision-bar-23andme-selling-their-potentially-life-saving-diagnostic-kits/96BRCYNB" rel="nofollow">https://petitions.whitehouse.gov/petition/overrule-fdas-deci...</a>
I wonder if another nuclear option is to just move the whole shebang to say, the Cayman Islands, China, or some jurisdiction outside the reach of the FDA and European regulators. Re-incorporate as a non-US entity.<p>Unlike buying medicine from foreign soil that can be interdicted, this is all electronic: shipping spit, and getting back HTML.
In fact, they've not only suspended health-related genetic tests, but they've done so <i>retroactively</i>. If you signed up for 23andme in the past two weeks, you're not getting what you paid for.
Well this sucks. I was going to pay for the test this weekend.<p>Anyone have any idea how useful the health data is without the 23andme interpretation? I'm guessing it will be basically useless.
I 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?<p>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.
Government, 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.
I bought 23andMe ages ago and haven't sent in my test yet. Because I purchased it quite a while ago, will I still be able to get all the info? If not, I'm gonna be pretty disappointed.