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23andme has suspended health-related genetic tests
- johnbpetersen 13y agoWell this sucks. I was going to pay for the test this weekend. Anyone have any idea how useful the health data is without the 23andme interpretation? I'm guessing it will be basically useless.
- kingkawn 13y agoTheir interpretations were based on poorly proven associations between genes and disease-outcomes. I bet with the info you could look up on wikipedia/google scholar much of what you needed to know. But it depends on the format of this data dump.
- Afforess 13y agoNo, that is pure FUD. 23andme provides a confidence assessment for the associations and risks. Here is a screenshot from their site: https://dl.dropboxusercontent.com/u/49805/confidence.png https://dl.dropboxusercontent.com/u/49805/confidence.png
- infocollector 13y agoAnd no one has problems with their privacy policy?
- Afforess 13y agoYour DNA is pretty much public domain anyway. You drop tons of it all over the place.
- infocollector 13y agoThankfully I do not label it with my name ;)
- kingkawn 13y agoAll well and good that intervals of confidence exist in medical research. But good understandings of these associations have been reached with very few genes. The categories alone do not prove that they apply broadly enough to justify the product.
- GraffitiTim 13y agoSince they're still going to provide the data to new users, I wonder if some of their interpretations could be recreated and published by existing users who still have access to the interpretations.
- khomenko 13y agoYes, for the mendelian ones that can be inferred in a relatively straightforward way from the raw data. Not really, for the more complicated risk assessments.
- sanxiyn 13y agoYou can get the basically same report running Promethease on 23andMe data dump. There is a website even providing automatic 23andMe data import using 23andMe's API.
- midas007 13y agoGet SNPs via https://www.23andme.com/you/download/ https://www.23andme.com/you/download/ and then process with http://www.snpedia.com/index.php/Promethease http://www.snpedia.com/index.php/Promethease
- khomenko 13y agoYou can run the raw data through a 3rd party tool like Promethease (http://snpedia.com/index.php/Promethease http://snpedia.com/index.php/Promethease) while you wait for the FDA kerfuffle to work itself out. YMMV though.
- Afforess 13y agoThis 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 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.
- sanxiyn 13y agoI 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.
- asdfaoeu 13y agoThe 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.
- 001sky 13y agoAs far as I'm concerned at that stage you might as well take homeopathy. How does this follow? No test is equivalent to ignorane. Using the test as a non-invasive prelim screen may be imperfect, but its hard to say the "null hypothesis" is equivalent. That would require that no information be present, which seems unlikely (if unproven). Or did you mean something else?
- chmars 13y agoIs there any way to export all existing test results and not just the raw data?
- khomenko 13y agoIf you think that's dumb, here are a couple of petitions you can sign: http://www.change.org/petitions/fda-administrator-margaret-hamburg-don-t-ban-home-genomics-kits http://www.change.org/petitions/fda-administrator-margaret-h... https://petitions.whitehouse.gov/petition/overrule-fdas-decision-bar-23andme-selling-their-potentially-life-saving-diagnostic-kits/96BRCYNB https://petitions.whitehouse.gov/petition/overrule-fdas-deci...
- jonnybgood 13y agoI think those petitions are highly dubious. Neither of them accurately references the FDA's issue with 23AM.
- winterswift 13y ago> highly dubious See: most things on Change.org.
- daeken 13y agoI 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.
- khomenko 13y agoYeah, you should be OK.
- bengotow 13y agoI don't think you'll get your results - at least not soon. The FDA said they needed to back up their claims that their assessment methodologies are accurate, and since they failed to respond to those requests they've been prohibited from performing the genetic tests and giving you the insights that you paid for. Don't think it matters when you bought the kit :-(
- khomenko 13y ago"Customers who purchased kits before November 22, 2013 will continue to have access to all the reports they’ve always had."
- bengotow 13y agoAhh interesting. At first I'd read that to mean that they weren't taking data down, and existing customers would still be able to access their reports. I figured that only applied to people who had already had a report generated.
- robomartin 13y agoGovernment, 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.
- johnpowell 13y agoOr 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.
- downandout 13y agoSince 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.
- cperciva 13y agoIn fact, they've not only suspended health-related genetic tests, but they've done so retroactively. If you signed up for 23andme in the past two weeks, you're not getting what you paid for.
- winterswift 13y agoNearly ordered myself a test before discovering this mess on the day the FDA sent their letter. I would really hope they'd provide some sort of compensation to those who're being screwed...doubtful that'll happen though.
- khomenko 13y agoEveryone who has ordered since November 22nd is offered a refund. The details are on the website and will come in the email. Have some faith, dude. Of course they have to do that.
- winterswift 13y agoAh, well that's good then.
- Steuard 13y agoWe 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 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" https://news.ycombinator.com/item?id=6796219 https://news.ycombinator.com/item?id=6796219 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. 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? 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. Someone needs to verify claims like that for the rest of us!
- bengotow 13y agoI 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.
- cromwellian 13y agoSo 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?
- elwell 13y agoTime to open source 23andme health-risk analysis code so we can run our raw data through it?
- deleted 13y ago[deleted]
- bausson 13y agoI 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.
- cromwellian 13y agoI 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. Unlike buying medicine from foreign soil that can be interdicted, this is all electronic: shipping spit, and getting back HTML.
- mithras 13y agoSo you'd like your genome to be in the hands of a Cayman Island company?
- cromwellian 13y agoAnd just what are they going to do with it? Target me with a biologically engineered virus? I'm shedding DNA with every breath. Your DNA is currently private thanks to security through obscurity, but if you've ever watched GATTACA, that security will disappear as DNA testing becomes faster, cheaper, accurate, and ubiquitous. People really need to get over paranoia over this and focus on what matters: laws against discrimination based on genetics.
- jadeddrag 13y agoCayman Island company is no more harmful than in the hands of a (likely CIA/NSA infested) USA company.
- billpg 13y agoGreat. How about the FDA deal with the claims made by homeopaths next?
- streptomycin 13y agoThey would love to, but they are limited in the scope of their authority. Homeopathy companies tend to label their products as "dietary supplements" so they don't fall under FDA drug regulations. When they slip up with their marketing, the FDA does get involved http://news.discovery.com/human/health/homeopathy-takes-hits-in-europe-us-120821.htm http://news.discovery.com/human/health/homeopathy-takes-hits... (see "Skirting Drug Regulations").