11 ms·
23andMe meets FDA standards, adds back wellness reports
- chaud 11y agoI would like to know how the new report compares to the old one. Also of note, the price has gone up from $99 (as of earlier this week) to $199. edit: This NYTimes article has more details: http://www.nytimes.com/2015/10/21/business/23andme-will-resume-giving-users-health-data.html http://www.nytimes.com/2015/10/21/business/23andme-will-resu... Now, after nearly two years, 23andMe is announcing on Wednesday that it will begin providing customers with health information again, though much less than before and with F.D.A. approval. The new health-related information 23andMe will provide is called carrier status. That relates to whether people have genetic mutations that could lead to a disease in their offspring, presuming the other parent has a mutation in the same gene and the child inherits both mutated genes. There will be information on 36 diseases, including cystic fibrosis, sickle cell anemia and Tay-Sachs.
- ska 11y agoI don't know anything about this particular filing, but the FDA is primarily concerned with you having demonstrated safety and efficacy. For this reason, I would suspect the new reports will not include anything that they could not provide scientific evidence for effective differentiation, as well as anything without convincing argument that a report would not increase workup rates, etc. with some inherent risk.
- brianbarker 11y agoI just like knowing I have the trait for smelling asparagus in urine.
- kej 11y agoThis doesn't seem like something you'd need a genetic test to determine.
- amelius 11y agoI guess that was the point of the joke. All the interesting pieces of information, and more, can't be released by order of the FDA.
- amarpatel 11y agoHahah agreed with @kej. Jokes aside, I've held off getting 23andMe because of this reason. Does anyone know?
- jegutman 11y agoThere have always been partners you can get the entire suite of results from.[1] I don't know how they haven't been restricted, but my guess is the FDA can't ban telling you what a SNP does, but the FDA can ban 23 and me selling it as a service connected somehow? Anyways, you can find out everything you wanted to know and a million other things you probably will have trouble of fully understanding. [1] https://promethease.com/ https://promethease.com/ and athletigen are two I've used that were pretty cool
- boulos 11y agoWait; I thought you didn't...
- starshadowx2 11y agoIt's been $199 CAD for at least a year or more now. I got mine when it was on a sale for $99. I guess the US version has been priced differently?
- legulere 11y agoThe international version that only covers heritage still is priced 99$. The local versions outside of the US that provided health coverage already were priced higher before.
- devonEnlis 11y agoI'm preparing a blog post on the differences between the old and new 23andMe reports, and how they compare to a raw data analysis with Enlis Genome Personal. Here are the headline numbers- Number of health-related traits reported: Old: 201 New: 36 RawData: 2109 Number of health-related variants reported: Old: 1283 New: 100 RawData: 13,537 I will also note that while they increased the price, they are still using the same genotyping chip that they released in December 2013
- xirdstl 11y agoNot speaking to the price, this makes sense. To achieve FDA approval, their reporting is much more conservative. That's probably for the best.
- greggman 11y agoI'm not saying you're wrong but would you mind explaining why you think that's for the best?
- lionyo 11y agoStatistics and risk are meaningless when your name is attached to the report. To go to the extreme, a 0.001% chance of genetic disease can drive a person to make emotional decisions.
- dekhn 11y agoCan you check if they still report tongue rolling as a Mendelian trait?
- methou 11y agoThe price in Europe is 99% and 20% off for additional kits. Shipping cost would be 42.99/62.99 for std/express shipping that takes weeks.
- mmastrac 11y agoI hope this means we can finally upgrade our results to the latest chip, or that they restore some of the SNPs they dropped in the later chips that make these reports impossible to compute. I've been waiting to unlock the Alzheimer's results for ages, but it always tells me that "upgrading to the latest platform is unavailable".
- berberous 11y agoI could be wrong, but I think you can still export your raw genetic data, right? If so, have you checked out Promethease? I have not used it in a while, but I imagine it will tell you most if not all of what 23andMe would have on Alzheimer's (and quite possibly more). http://www.snpedia.com/index.php/Promethease http://www.snpedia.com/index.php/Promethease https://promethease.com/ https://promethease.com/
- csl 11y agoI've made a 23andMe parser that can report on this. Actually, it covers quite a lot of their health results: https://github.com/cslarsen/dna-traits https://github.com/cslarsen/dna-traits The test for Alzheimers is here: https://github.com/cslarsen/dna-traits/blob/master/py-dnatraits/dna_traits/health.py#L17 https://github.com/cslarsen/dna-traits/blob/master/py-dnatra... (the algorithm used to be patented, by the way). By closely reading the algorithm, you can probably find out yourself, given that 23andMe still lets you browse your genome. To see all health reports, run this file on the downloaded genome: https://github.com/cslarsen/dna-traits/blob/master/py-dnatraits/bin/health-risks.py https://github.com/cslarsen/dna-traits/blob/master/py-dnatra... (you have to compile the C++ code first) Actually was playing with the idea of monetizing off this project, but the laws in my country prohibit me from doing so. In fact, just using the program I made is illegal unless its my own genome.
- farresito 11y agoWoah. Quite interesting! Thank you. I've been increasingly interested in bioinformatics and your project seems quite nice. I will definitely give it a try.
- andrewtbham 11y agoPlease someone in another country provide the data 23 and me used to provide!!!
- calebm 11y agoWhat information is lacking from the new reports? And do they provide all the raw data? If so, is it possible to do your own research based on that raw data? (I'm not arguing with you - I wish they would provide all the data possible).
- oneJob 11y agoalso, I don't trust them with my DNA data anymore.
- exacube 11y agowhy, what happened?
- breitling 11y agoI remember reading somewhere that they share the DNA info with gov't agencies.
- calebm 11y agogattaca!
- cryoshon 11y agoProbably. Unfortunately, this precludes someone who is privacy-conscious from using these products, as cool as they may seem. I can't imagine how the government would put this information to anything other than malicious use. SNP sequencing is the ultimate fingerprint, far more individually identifying than anything else as of yet. Imagine having 900,000+ criterion to cross reference to determine identity.
- darkmighty 11y agoIf the gov't really want a DNA sample from you is it that hard to obtain? I understand this allows them to do it en masse though.
- calgoo 11y agoWhat happened was that the police was using some publicly available data to cross reference with cold cases. Then when they found a familiar match, the produced a warrant to get the identity of the family member that was registered. The main issue was that the info was available, so some tech just ran the comparison. However, it feels like it would be way to easy to request the information directly with a warrant and that's it. Using something like: "We need to save the women and children, here is a list of unidentified DNA samples, please compare them to all your database."
- PeanutNore 11y agoIn my limited understanding, this means that you can now pay twice as much as before to receive much less information than before. There must be a lab located outside the US (and with no US footprint or marketing) that will nonetheless provide full results to anyone providing a sample.
- weisser 11y agoThis headline (and the one from the NYTimes) is a bit misleading – 23andMe is resuming giving health data but they’re actually giving a different kind of data. This new data is related to carrier status – genetic mutations that could lead to disease in your offspring. They still hope to gain approval to give info on health risks (what they provided up until 2013), but there is no public estimate for how long it might take. It will happen, it’s just a matter of time.
- epistasis 11y agoYou could always get your data: https://customercare.23andme.com/hc/en-us/articles/202907670-Accessing-your-Raw-Data https://customercare.23andme.com/hc/en-us/articles/202907670... The iffy part was the medical advice.
- suprgeek 11y agoCan we ask for a Test and once we get the Results optionally have them destroy all records except the financial transaction ones? From their privacy policy: >How is my privacy protected? >We will not share your individual-level information with any third party without your explicit consent Both "individual-level" and "third-party" still leave a LOT of room for things to be shared. - At what level is the data allowed to be shared if not "individual-level"? - Exactly who are third parties (is Google a third party?) and who decides that? Can it change tomorrow? - What happens in the case they are bought out by some one? If they go bankrupt? What happens to the data? Still too many unexplained items
- kenbellows 11y ago"not 'individual-level'" sounds to me like anonymous statistical information that is not personally identifiable; is that called out anywhere in their privacy policy?
- esaym 11y agoMan, why is it so expensive? To test my wife and I would be nearly $400. I mean sure, it might help me be able to pre-treat any known trait based disease but still.. If all they are doing is running some DNA through a database, seems like the cost should getting lower, not higher.
- rcthompson 11y agoThey're also maintaining that database and adding to it over time as our understanding of genetically-linked diseases evolves.
- chanux 11y agoAnd making money off the (anonymized) data as well?
- benchtobedside 11y agoThat is correct - using it to develop their own therapeutic candidates in fact [1] [1] http://www.forbes.com/sites/matthewherper/2015/03/12/23andme-enters-the-drug-business-just-as-apple-changes-it/ http://www.forbes.com/sites/matthewherper/2015/03/12/23andme...
- Kneedler 11y agoI believe the $99 kits were sold as a loss leader to grow their database and establish themselves as a leader in the space. The actual cost to the company was/is much higher.
- mbreese 11y agoSelling kits isn't how they make their money. So, selling the tests at a loss shouldn't be surprising.
- SwellJoe 11y agoThere's another way to look at it: Compared to medical regulated DNA tests, such as those for breast cancer risk or other types of risk factors, which can cost in the thousands per marker, 23andme is astonishingly cheap. While I could never bring myself to spend the $199, I was a very early adopter when it went on sale for DNA day (maybe the first DNA day sale), and the rest of my family bought the next time it went on sale for DNA day a year later. Now that medical results are back, I think it is worth either price, particularly if you have any concerns about genetic health issues being passed down to you. In my case, my father was schizophrenic (and a couple of other relatives on the same side of the family likely suffered from undiagnosed mental illness based on what I know of their behavior and the details of their violent deaths), so I was more than a little curious about whether I had any of the genetic hints that I might suffer the same fate. I don't, and knowing that I don't have the couple of markers known to 23andme was worth at least $99. A few years after we all signed up for 23andme, my father passed away of pancreatic cancer, which can also be a genetic condition, and so I was able to check for the risk factors that are known (though my father also lacked those markers, so it's either a marker that is unknown to 23andme, or he was not genetically predisposed to pancreatic cancer in his case). That was, again, worth at least $99, to me. I know in either case, the ability of 23andme to predict those diseases is low, and it shouldn't replace hands-on medical care and paying attention to warnings signs, but it does provide some predictive power. And, for a while they were doing original research (polling their customers and comparing data to produce reports), which was really cool and fun to see happening. I don't think they're still doing that, maybe because of the FDA ruling. When the medical stuff went away, I stopped recommending 23andme to friends and family, as it no longer held any interest for me. The family tree functionality is neat, I guess, but I'm not Mormon, and don't have a huge amount of interest in whether I'm related to somebody interesting 200 years ago (I'm probably not; I come from very poor white trash stock). In short, the fact that we're arguing over whether a genetic profile is expensive at $199 or at $99 is a laughable first world problem. I'd like it if more of the world could afford it, and my signing up early was part of my encouragement for that to happen; I want it to be possible for everyone to look at their genetic predispositions and such, and take some of their medical care into their own hands with more informed choices. So, I opted in early. I would have bought eventually at $199, if they hadn't ever offered the $99 deal. But, I too, would like to see it getting cheaper. It's been many years now, since I bought in at $99. At some point, they've gotta be thinking in terms of making it more accessible to more people. There are huge swaths of people for whom $199 is not chump change.
- refurb 11y agoAnyone else see this Forbes article?[1] It seems to indicate a high level of naivety on the part of 23&Me in terms of the regulatory requirements around genetic testing. What Hibbs found was that 23andMe and the FDA were not even speaking the same language. The FDA is guided by laws and regulations that limit what it can say, and 23andMe wasn’t picking up on the agency’s cues. FDA officials would leave 23andMe an opening to change the way carrier testing was regulated, for instance, and 23andMe would ask an unrelated question. A part of me thinks it wasn't naivety and it was more "move fast and break things". [1]http://www.forbes.com/sites/matthewherper/2015/10/21/23andmes-triumph-and-the-long-road-ahead/ http://www.forbes.com/sites/matthewherper/2015/10/21/23andme...
- SilasX 11y ago>A part of me thinks it wasn't naivety and it was more "move fast and break things". Or "I did a jerkish move (like playing dumb), and they didn't call me out on it. I've discovered a mind hack!"
- cubano 11y agoIs it just me or does this sounds suspiciously like the Uber/Airbnb model? Seems to be working ok for them. Perhaps the nature of genetic testing changes things.
- mbreese 11y ago23andMe falls under Federal regulations - FDA. Uber and AirBnB operate in largely local/state regulated markets. It's harder to move fast and break things with a Federal regulator.
- mtgx 11y agoI wonder if this is why they finally got their approval: http://fusion.net/story/215204/law-enforcement-agencies-are-asking-ancestry-com-and-23andme-for-their-customers-dna/ http://fusion.net/story/215204/law-enforcement-agencies-are-...
- travisp 11y agoProbably not: https://www.23andme.com/transparency-report/ https://www.23andme.com/transparency-report/
- superkuh 11y agoIf a US national security letter with a gag were used it wouldn't show up here.
- travisp 11y agoAbsolutely true. But that has nothing to do with the original comment which was about traditional law enforcement requests for information. Given that 23andme says they haven't actually given any information to the police, it seems unlikely that cooperation with the police is why their product is approved.
- tdaltonc 11y agoWhy don't they just setup a partner outside the US? The US based company distributes the 'device' (ie the check swab) and the sequencing, and then users can export their data to a non-US website that explains what all of the SNP's mean?
- op00to 11y ago23andMe can do whatever they want with your data. It totally boggles my mind that someone would give a private company legal, full, and complete access to what makes you, you. We're still in the infancy of understanding what we can do with our genomes. Giving all our information over to an entity without a fiduciary responsibility to protecting your personal data is just idiotic.
- breck 11y agoIf everyone had that attitude we'd still be using horses to get from point A to point B. :)
- x0x0 11y agoYeah, but Ford didn't offer any pig who could dig up a compliant judge the ability to go spelunking through the dna of myself and all my relatives.
- op00to 11y agoI don't follow your analogy. How does technological advancement in transportation relate to the privacy and security of our own genomes?
- breck 11y agoEarly adopters accept risks that op calls "idiotic" because they believe in potential benefits of new tech. Without those early adopters we would not have new tech.
- aeturnum 11y agoWe're still in the infancy of diagnosing psychological state through word choice, yet uninformed people still talk to other people over chat. We're still in the infancy of detecting disease through microbiome analysis, yet some foolish people still meet in person without signed contracts not to collect that information. We're still in the infancy of analyzing video to detect mental state, yet people routinely go out into public without comprehensive agreements not to record or analyze their behavior. I understand your concern about genetic information, as it's easy to understand the impact and the potential information gleaned. That said, the cost v.s. risks v.s. benefit of the 23andme service work for me - though I would not say that they should work for anyone else. It's good to think about potential future risks, but believing too much in the malevolence and competence of people from the future is often a mistake (see: lots of cold war policies).
- rjurney 11y agoThis is cool, and I'm glad its back. That being said, I got about 3 minutes joy from reading my profile again. Paid for it five years ago. Still not useful for me :/
- LordHumungous 11y agoWelcome to the world of medicine techies, where you have to comprehensively prove that your idea works or gtfo. Quite different from the Silicon Valley ethos that you're used to.
- Hydraulix989 11y agoThis news of their FDA approval came right after news of their latest $155mm funding round which tells us that their new investors DEFINITELY knew about this before the public. [1] I can't imagine Fidelity Capital pouring millions into a company that got blocked by the FDA, and I was shocked to hear the news that they raised that much money until today when I found out that the FDA approved their DNA screening. I mean, they were dead as in last nail in the coffin status before that. Not only that, recent news just broke that law enforcement now have access to members' DNA from 23andMe -- the federal government must have been appeased. [2] As Saul Goodman says: "There's always a way to oil everyone's lock." [1] http://venturebeat.com/2015/10/14/23andme-raises-115m-to-grow-its-dna-health-test-technology-globally/ http://venturebeat.com/2015/10/14/23andme-raises-115m-to-gro... [2] http://thinkprogress.org/justice/2015/10/19/3713666/police-tap-ancestry-for-dna/ http://thinkprogress.org/justice/2015/10/19/3713666/police-t...
- dekhn 11y agoWelcome back to the fold, 23&Me. Are the 23&Me health reports still saying that tongue rolling is a Mendelian trait? If you don't get details like that right, it's hard to trust the rest of your health data.