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FDA Authorizes Ten 23andme Genetic Health Risk Reports
- CaliforniaKarl 9y agoI wonder, does that mean anyone who's already submitted a sample to 23andme will get these reports, or is a new sample required?
- jjeaff 9y agoIf you have already submitted a sample, you will get a report. Since 23andme maps your whole genome, they simply compare the existing data as new finding are approved. OR if you are like some and signed up early before the FDA crackdown, you already got all this information and now they are just reappearing little by little.
- Animats 9y agoSince 23andme maps your whole genome... They don't go that far. A full genome sequencing costs around $2900 as of 2015. (Which is amazing, since the first one cost billions.) Maybe $1000 with the new Illumina HiSeq X Ten sequencing system. Data from a full genome sequencing is about 80GB. (Opportunity here for specialized compression - 98% of the genome for humans is the same.) 23andme is testing for about 100,000 known patterns using a much simpler approach for about a tenth of the price.
- nojvek 9y agoWhere can I get my full genome sequenced?
- Animats 9y agoLots of places. Genomics Personalized Health in Santa Monica offers the service to individuals for $2500.[1] Includes cloud storage for the data. They have a list of medical consultants who can help interpret the data; they just give you the bits. List of service providers.[2] [1] https://genomicspersonalizedhealth.com/ https://genomicspersonalizedhealth.com/ [2] https://www.scienceexchange.com/services/whole-genome-seq https://www.scienceexchange.com/services/whole-genome-seq
- crispyambulance 9y ago23andMe uses genotyping. IANAMB, but I think that means they run a series of assays each of which "examines" a small PART of the genome to look for something very specific. As part of their process, however, they could extract the DNA and keep a sample frozen for later assays or even full genome sequencing but I don't know if they do that. https://customercare.23andme.com/hc/en-us/articles/202904600-What-is-the-difference-between-genotyping-and-sequencing- https://customercare.23andme.com/hc/en-us/articles/202904600...
- cjbprime 9y agoThey give you the option when you sign up, of retaining your sample for later sequencing runs on newer/more comprehensive hardware, or discarding it.
- ksenzee 9y agoFrom https://customercare.23andme.com/hc/en-us/articles/202907980/ https://customercare.23andme.com/hc/en-us/articles/202907980...: "Current 23andMe customers will be notified directly on their eligibility for receiving new genetic health risk reports." Sounds like it depends on which package you bought.
- manmal 9y agoI'm 99.9% sure that a new sample is not required. All of those risk factors can already be looked at with other tools which import raw data from your 23andme account. Eg Promethease evaluates hundreds of genes (both the risks and positive traits) for a couple dollars: http://snpedia.com/index.php/Promethease http://snpedia.com/index.php/Promethease
- BurningFrog 9y agoNow they sell people only "ancestry" report for half the (now doubled) price. They probably don't get it, but I expect everyone on a "full" plan does. They already have the DNA info.
- wavefunction 9y agoI got myself tested years ago with 23andMe and you do indeed get ancestry reports. I also get 'pings' every so often from likely distant relatives (3rd-5th cousins if anything). One lady had been adopted as an infant and was desperately seeking any sort of relative who could tell her something about her origins. I told her what I knew about the families I am descended from but man did I feel bad for her. We were likely distantly related and I'm not sure my info helped, but that would be a pretty remarkable upside to genetic testing for people who want answers.
- selimthegrim 9y agoI was actually able to almost completely solve the mystery of where my great-grandmother came from (adopted as a baby in the South in the early 20th century) using genetic testing.
- okket 9y agoFDA press release: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm551185.htm https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/u...
- butisaidsudo 9y ago> For several years, 23andMe has worked on demonstrating that its reports are easy to understand and analytically valid... I guess these are different reports, but I know a genetic counsellor who describes 23andMe's carrier screening tests as "the bane of their existence". Those reports seem not-so-easy to understand based on the patients she sees. One problem is that they warn that your offspring are at high risk for some condition, when really "high risk" means 0.5% higher risk than the general population. The other is that they may say you are not a carrier for a certain condition, when they only test for one variant of it, where proper tests will test for multiple variants. They can both scare and soothe irresponsibly.
- Kequc 9y agoWhen I signed up the sample they took was spit in a vial. It never clicked for me that this was going to be the most scientifically accurate reading of my health in all the world. I took part because it could give me some scaring and soothing. But I assumed I'd go get a real test done if I was actually worried or interested about something specifically. The website repeats this sentiment over and over, I learned about all kinds of interesting genetic stuff. I'm sure that's what it's for. I shouldn't be surprised that many people take what it says as gospel.
- eli 9y agoThe "real" genetic test I took in doctor's office to screen for a condition worked by spitting in a bottle too. It's a reasonable way to collect DNA.
- nether 9y ago> When I signed up the sample they took was spit in a vial. Yes, and? I don't see the significance of the testing medium here. DNA sequencing from hair or blood or saliva will yield identical results.
- aarongolliver 9y agoThey're saying the testing medium itself made the test appear less scientific/accurate (to them) than it actually is. Perhaps if it had been a hair sample it would have appeared more scientific (again, to them).
- phkahler 9y agoIs there any way to just have your entire genome sequenced and get all the data in a software-friendly format? At that point there could/should be some open source software for analyzing it and finding common or well understood things like this. That way the software could be updated and people could re-run their analysis to look for newly discovered stuff. I think this would be an awesome amount of fun. I for one would be interested in looking for certain gene variants that are not mentioned at all over at 23andMe.
- dekhn 9y agoI did Illumina UYG. As part of that I got a 1TB hard drive with the nearly-raw files (BAM format with raw reads, VCF with variants). Lots of people say " I for one would be interested in looking for certain gene variants that are not mentioned at all over at 23andMe." but they either never do anything with the data, or they look into it and realize that SNP analysis of gene variants is still a charltan's game.
- Paul-ish 9y ago> 23andMe is now the only company authorized by the FDA to provide personal genetic health risk reports without a prescription. Will it be hard for competitors to get this authorization as well?
- yo-code-sucks 9y agoYup
- soneca 9y agoMy opinion is that this test is useless at the least and dangerous at the most. It provides information that in almost the totality of the cases no one can correctly interpretate and transform in actionable health advice. Not scientists, not doctors, much less consumers. But it is sold as a cutting edge scientific resource that will improve your life. It wont. Not even increasing the chance that you might avoid something somehow, that's the fallacy. For our level of knowledge regarding causality in biology and genetics, I believe this test is as good as buying your astrological map.
- tlb 9y agoDo you believe that no genetic tests at all can be useful? Like, even for Huntingtons or Cystic Fibrosis? Or is it just these specific tests you don't trust?
- soneca 9y agoI am a total layman in biology, genetics, and health, so I have no broader or deeper opinion at all on the subject. I specifically don't believe that this 23andme (or similar) test is any good for your health or useful at all. And selling it as such is dangerous.
- onewaystreet 9y agoThen what are you basing your opinion on?
- soneca 9y agoOn articles that I read on the subject (the subject of 23andme tests, not genetics in general) and my own capacity for acquiring information and transforming them into learnings and opinions that I form to better live my life.
- cjbprime 9y agosoneca has a good point here (perhaps accidentally), which is that you'll notice that 23andme doesn't return Huntington's or CF results, and it sounds like the reason is because they would be so useful and predictive of disease. Which does put 23andme's health results in this realm soneca described of "things that might be interesting, but can't be very actionable because they don't want to scare you by returning actually actionable information to you".
- Balgair 9y agoAre they still saying that by submitting a sample to them, that they then own your genome and can sell it to whoever they want? I'd love to get mine sequenced and check it out a bit, but not if they are going to sell it off to a million shady companies whenever they go bankrupt (maybe 50+ years, but still)
- deleted 9y ago[deleted]
- snowpanda 9y agoHaven't read it fully, but i think it would be on this page: https://www.23andme.com/about/privacy/ https://www.23andme.com/about/privacy/
- fourstar 9y agoI ended up canceling my account because of this reason. That and the fact that a bunch of random people started trying to hit me up because apparently we were "linked".
- Balgair 9y agoYeah, that's pretty creepy. Thank you very much for the anecdote and information.
- unethical_ban 9y agoYou can turn off the discoverability.
- caio1982 9y ago"We will not sell, lease, or rent your individual-level information (i.e., information about a single individual's genotypes, diseases or other traits/characteristics) to any third-party or to a third-party for research purposes without your explicit consent." And... "Unless you choose to store your sample with 23andMe (called consent to "bio-banking", which can be found here and changed in your settings), your saliva samples and DNA are destroyed after the laboratory completes its work, unless the laboratory's legal and regulatory requirements require it to maintain physical samples." Also: https://www.23andme.com/en-int/legal/biobanking/ https://www.23andme.com/en-int/legal/biobanking/
- kakarot 9y agoDNA readings will soon be the new Horoscopes...
- dikdik 9y agoThere are already companies out there using DNA sequencing for some absolutely bullshit products...Vinome comes to mind, they suggest wine you might like based on your genome. Personally, I'm all for it though. It's a way to have fun with science. As a scientist, it's nice to have stupid "horoscopes" to keep life interesting.
- magic_beans 9y agoWhoa. That is a pretty fine gimmick there. I'm amazed that anyone wealthy enough to afford that kind of service would be stupid enough to use it.
- kakarot 9y agoPoor people are often uneducated by necessity, but blood-rich folk are sometimes uneducated by choice. What a luxury!
- tudorw 9y agoI found some useful information in my 23andme report regarding poor or undesirable responses to quite a few pharmaceuticals, my phase 1 metabolism is... novel...
- mrfusion 9y agoThe FDA thinks it can decide what I can learn about my own body.
- dragonwriter 9y agoNo, the FDA thinks it can decide whether someone can sell a product claiming to diagnose disease. Because, fairly explicitly in the Food, Drug, and Cosmetics Act, it can, and, in fact, is obligated to.
- jdavis703 9y ago23 and Me gives you the raw genetic report. If you're sophisticated enough to not panic and jump out a window because you have some terrible disease, the assumption is you can also find open source data and/or software that will give you this same information. The problem with what 23andme was doing is going direct-to-consumer with tests that were potentially sketchy. If you're willing to risk sketchy information you can find all kinds of bleeding edge research on your particular genetic makeup and choose how to handle it.
- mrfusion 9y agoWe're acting like adults can't handle getting bad news. We're infantilizing them. People get bad news all the time and don't jump out windows. By your argument we should regulate who's allowed to tell people that a relative has died.
- PeterisP 9y agoAdults can't handle misleading and inaccurate health information, and are known to spend large amounts of money to e.g. literal snake oil peddlers back when peddling snake oil as a cure-all wasn't prohibited. Yes, we are regulating who's allowed to tell people that a relative is going to die, and we're asking people who do so to show evidence that they know what they are talking about. If someone would go around selling a service "is your relative going to die" by guessing or simply telling what they want to hear, then that should be regulated and prohibited. As another poster said, "One problem is that they warn that your offspring are at high risk for some condition, when really "high risk" means 0.5% higher risk than the general population. The other is that they may say you are not a carrier for a certain condition, when they only test for one variant of it, where proper tests will test for multiple variants." If you tell people "we ran a test for X and it was positive/negative" then you'd better be able to show that whatever rituals you performed actually lead to reasonable information about X. Simply having a test that has some information related to X (e.g. if it would be used together with other factors to diagnose X or not X) doesn't mean that you can honestly describe it as "test indicating a high risk of X" - it may be that this particular test is indicating that, and it may be that it (alone) is misleading, and we need someone (e.g. FDA) to draw a line.
- deleted 9y ago[deleted]
- DownSyndrome 9y ago23andMe is very offensive in assuming all humans only have 56 genes.
- astrange 9y agoIn fact almost everyone seems to have more than that: http://www.nytimes.com/2013/09/17/science/dna-double-take.html http://www.nytimes.com/2013/09/17/science/dna-double-take.ht...
- awalton 9y ago...right as the Republicans want to remove some of the protections afforded by GINA. [1] While I'm sure this helps 23andMe's business case, it's a seriously scary time to consider getting your genome sequenced right now. [1]: https://www.washingtonpost.com/news/to-your-health/wp/2017/03/11/employees-who-decline-genetic-testing-could-face-penalities-under-proposed-bill/ https://www.washingtonpost.com/news/to-your-health/wp/2017/0...
- deusofnull 9y agoCan't wait till the require these for health insurance... Seriously, is there regulation protecting people from "pre-existing conditions" discovered by their genetic analysis?
- jinxedID 9y agoYes, there is in the United States. Oddly enough there are no such laws in Canada.
- thinkmoore 9y agoComing soon to an insurance broker near you: https://www.newsroom.co.nz/@health--science/2017/04/04/17972/how-your-genes-affect-your-insurance https://www.newsroom.co.nz/@health--science/2017/04/04/17972... Of course, this article is about New Zealand, but I will not be surprised to see similar things in the States. Thankfully ACA provides protection for health insurance, but we're already seeing things like https://www.congress.gov/bill/115th-congress/house-bill/1313 https://www.congress.gov/bill/115th-congress/house-bill/1313.
- Khaine 9y agoSo if someone was interested in getting a genetic test to find out ancestry and health information, what service is best?
- grandalf 9y agoI'm surprised to see all the fear-mongering in this thread. We leave genetic material behind everywhere we go. 23andme analyzes only a small subset of one's DNA. The most important thing to realize about genetics is that very few health conditions (and even traits) are highly correlated with a specific genotype. Some are, but the reason something like 23andme hasn't revolutionized health is because the correlations for most things are weak. 23andme does a good job of showing just how weak in the results. I'm 52% likely to have the eye color I have even though both parents have that color. I'm the tallest in my generation (in my family) yet my genes are mostly for below average height. Over time, with a lot more data and a lot more correlation analysis with health and behavioral data, there will be more actionable information for the average customer. As it stands, 23andme is useful for the following reasons: - the data is entertaining. It's fun to find out how much neanderthal DNA one has, etc. - the ancestry results are interesting. - the health results make it clear just how little impact genetics has in most aspects of health. Yes there are some big exceptions, but those are a minuscule percentage. By joining 23andme you get a chance to watch the studies unfold and plug in your own data. For a curious, patient person, this offers a great way to make an interesting area of science a bit more salient.
- marchenko 9y agoYour comment could also be taken as an argument for being a late-adopter of commercial genetic testing services: 1. The AUC (predictive power)for most traits is currently very weak 2. The genetic privacy protection landscape is currently quite volatile Taken together this puts the consumer in the situation of having data that is of middling utility for them personally, but is of great potential utility for the testing company and insurers. A small increase over the average population susceptibility for trait X is often non-actionable for you personally, but over several traits might be sufficient to shift you into a different insurance risk class. If you have privacy concerns and are interested in your risk profile for certain traits, look into whether a kit is available for those traits alone. You may wish to combine different kits from different providers to interrogate multiple regions (a more expensive strategy for the privacy-sensitive). There are a few companies that will put together a bespoke panel. At present, it may be prudent to take a hacker approach to genetic testing. https://isogg.org/wiki/List_of_DNA_testing_companies https://isogg.org/wiki/List_of_DNA_testing_companies
- Gatsky 9y agoI think people are forgetting to ask the key question - Cui bono? Who benefits? 23andme definitely benefits - all the data they have collected is very valuable, and they intend to sell it to pharmaceutical companies etc. On the other hand, working in genomics, in my opinion the benefit to any one person having their genome tested in this manner is minimal. The simple reason is that most genetic alterations have low penetrance for phenotypes or involve complex interactions.
- jamesblonde 9y agoI would have. I had 2 kids diagnosed with cystic fibrosis the same day, so it would have helped me. Many phenotypes are complex, but not all are.
- csl 9y agoWhen 23andMe took down their health reports, I reimplemented most of them myself: https://github.com/cslarsen/arv/ https://github.com/cslarsen/arv/ (I.e., arv is a newer version of the older dna-traits, which includes the actual health reports: https://github.com/cslarsen/dna-traits/ https://github.com/cslarsen/dna-traits/) Just `pip install arv`, `python -m arv --example genome.txt` and you're good to go (it's fast as well, parses in 60-70ms).
- ganeshkrishnan 9y agoI used promethease report generation and it gave me around 500 paged document about everything related to my DNA.