15 ms·

FDA Orders Genetic Testing Firm 23andMe to Halt Sales

79 points by wikiburner 13y ago

DigitalSea 13y ago
Completely understandable and it's a fair point people might undergo unnecessary surgery as a result of a false positive (like having breast tissue removed preemptively after false positives for chances of contracting breast cancer). 23andMe is a nice idea, but you can't beat an old fashioned regular trip to the doctor and blood test to check for these things.
- jfoster 13y ago
  Unless 23andme start selling the surgery as well, doctors will be involved before any surgery happens.
- gkoberger 13y ago
  Think about the opposite, though -- most people don't get tested for anything, especially weird/uncommon conditions. Tests like 23andme aren't something your local doctor does every checkup. For $100, people who otherwise would have been clueless know if there's something they should ask their doctor about. In this case, I think some false positives are better than ignorance. Worst case, you think "oh no, I'm predisposed to ___!" for a few days until you make it to a doctor who can tell you for sure. It's fair to say 23andme has saved far more lives than it's hurt.
  - mikevm 13y ago
    > It's fair to say 23andme has saved far more lives than it's hurt. Please back this statement with evidence, otherwise it's just hot air.
  - felipe 13y ago
    > Tests like 23andme aren't something your local doctor does every checkup. Fair enough. So why not let FDA go through their process, do their investigation, and once approved people could safely rely on 23andme.
    - coryrc 13y ago
      We could write something untruthful or harmful in the newspaper (maybe about acai berry weight loss). So why not let the government go through a process, investigate whether what we write is conducive to the public good, and once approved it can be safely published.
- dreamdu5t 13y ago
  Just as there will be people who get surgery due to false positives (which happen with regulated testing too), there are lots of people who otherwise have no preferred means of testing if it's regulated away.
  - teraflop 13y ago
    The FDA doesn't appear to be trying to shut down 23andMe, just trying to force them to file the appropriate documentation and follow the same rules as everyone else regarding how they advertise their services.
- berberous 13y ago
  The idea that someone is going to get their breast tissue removed based on 23andMe alone strikes me as unbelievable. A doctor would be consulted, who would likely order more appropriate diagnostic tests first. I would imagine any doctor that jumped straight into surgery based off of a 23andMe print out would eventually be sued for negligence.
  - deleted 13y ago
    [deleted]
dangero 13y ago
Has 23andMe told their side of the story yet? The FDA's press release made it sound like 23andMe was very negligent, but there has to be more to it than that. I can't imagine a company just ignoring the FDA's requests.
- fjarlq 13y ago
  They posted this to Facebook: Hi everyone, Many of you have seen and been asking about this morning's news. Here's the statement we've issued to the media: "We have received the warning letter from the Food and Drug Administration. We recognize that we have not met the FDA's expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns." We'll continue to keep you updated here as we know more. Thanks for all the messages of support! https://www.facebook.com/23andMe/posts/10152374363517802 https://www.facebook.com/23andMe/posts/10152374363517802
bcl 13y ago
From the 23andme TOS: "You should not change your health behaviors solely on the basis of information from 23andMe. Make sure to discuss your Genetic Information with a physician or other health care provider before you act upon the Genetic Information resulting from 23andMe Services. For most common diseases, the genes we know about are only responsible for a small fraction of the risk. There may be unknown genes, environmental factors, or lifestyle choices that are far more important predictors. If your data indicate that you are not at elevated genetic risk for a particular disease or condition, you should not feel that you are protected. The opposite is also true; if your data indicate you are at an elevated genetic risk for a particular disease or condition, it does not mean you will definitively develop the disease or condition. In either case, if you have concerns or questions about what you learn through 23andMe, you should contact your physician or other health care provider." https://www.23andme.com/about/tos/ https://www.23andme.com/about/tos/
- edmccard 13y ago
  > From the 23andme TOS: > ... Make sure to discuss your Genetic Information ... before you act upon the Genetic Information The problems are not about what someone might do with their "Genetic Information", but with the accuracy of the "Genetic Information" in the first place. The false positives/false negatives mentioned in the FDA's warning letter[1] are not referring to misdiagnoses based on the 23AndMe's results, but to misidentification of genes in those results (as the letter describes it, "false genotype results") In a nutshell: 23AndMe claim that the genetic variants in their results are (to some degree of accuracy) genetic variants that you actually have; the FDA says that 23AndMe have not provided enough evidence for these claims. [1] http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376296.htm http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2...
- Karunamon 13y ago
  This is what I don't get. It's not like this is hidden. The site is completely upfront about what they are and what they do, what studies and results have more confidence and which less. Maybe I'm just a little cynical here, but it seems the FDA would have better things to do with their time. That in mind, I wonder what spurred this...
taspeotis 13y ago
Previous discussion https://news.ycombinator.com/item?id=6794122 https://news.ycombinator.com/item?id=6794122 317 points by jefffoster 14 hours ago | flag | cached | share | 377 comments
djjose 13y ago
The crux of their troubles comes from this paragraph in the Warning Letter: "However, even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses that the firm identified in its submissions. In your letter dated January 9, 2013, you stated that the firm is “completing the additional analytical and clinical validations for the tests that have been submitted” and is “planning extensive labeling studies that will take several months to complete.” Thus, months after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS. It is now eleven months later, and you have yet to provide FDA with any new information about these tests." The FDA, while being a pain in the rear at times, will actually work with you to meet compliance. But you have to show work and be continually in touch with them and show progress (and document everything according to your own procedures, complying to regulations of course). You can't just say you're working on compliance and then not follow through and show evidence. The issue for 23andMe is the on-label use of the product "in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body." They market the product this way. If you want to market your product as such, you have to show proof to the FDA and receive approval to label the medical product in this manner. It looks like 23andMe is either not working towards compliance (and is misleading the FDA) or is doing a terrible job documenting their work towards compliance and keeping the FDA abreast (my guess is this is what's happening). That in itself will get you in trouble, but then expanding your marketing for even more on-label use of the product - which hasn't been submitted to the FDA apparently - while at the same time not having FDA approval for the original use is just plain stupid.
- dpe82 13y ago
  I used to work as a state legislative aid; one of my duties was helping constituents work with state agencies on regulatory matters. I learned from that experience most regulators (at least at the state level, I imagine federal is similar) usually care much more about compliance than enforcement. As long as you aren't doing something egregious and make a good faith effort to work with them they'll often be pretty reasonable within the confines of the law. However if you ignore them, they'll come down on you like a ton of bricks. It sounds like 23andMe has been ignoring them.
Michael_Murray 13y ago
Of course this happens the week after I submit my sample.... ;-)
snitko 13y ago
FDA as always sticking their nose into something they shouldn't. Let the people decide whether they want to use this particular service or not. People ought to be free to choose. Otherwise it's not consumer protection, it's consumer dictatorship.
- Angostura 13y ago
  But it seems clear that it really shouldn't be used for anything in its current state.
- thelambentonion 13y ago
  This really looks like the FDA sticking their nose into something they should. 23andMe is making false claims about the efficacy of their test in their marketing material and the FDA isn't okay with that. They're not even ordering 23andMe to stop testing, just to stop marketing their service as something it isn't.
jacoblyles 13y ago
I'd rather see them shut down the FDA than 23andMe
- cscurmudgeon 13y ago
  I am not a big fan of possible snake oil even if it comes in hipster startup form.
  - snitko 13y ago
    Great, don't use it then. Why do you believe you have the right to tell other people what to buy for their money?
    - consonants 13y ago
      Why do you believe the pursuit of profits trumps the democratic decisions of the people?
    - cscurmudgeon 13y ago
      >> Why do you believe you have the right to tell other people what to buy for their money? I am not doing that. The FDA is doing that. That is their job. If you disagree with that, you should also be okay with charlatans selling snake oil.
      - snitko 13y ago
        You are paying for it with your tax money, therefore you are doing it. I'm not okay with selling snake oil, but I think it is wrong to prevent other people from buying it. It's okay to inform them it's a bad idea to buy certain things - it's dictatorship to prevent them from doing so. If you can't convince somebody, it's your problem, not that person's problem. FDA doesn't convince, it just comes and shuts you down or doesn't allow you on the market. Besides, where is FDA when charlatans sell homeopathic medicine? Show me a little consistency here.
        deleted 13y ago
shubb 13y ago
The problem with 23andmMe is that genetics can't currently tell us much about our risk of developing common genetic diseases. Some diseases are caused by a single gene. These are rare because people with a dominant copy of that gene are less likely to reproduce, so they are mostly deselected. Many of these monogenic diseases have a pretty major effect. You know if you have them (and probably died in childhood). Pre-natal genetic counseling is where finding these is useful. Most of the diseases 23andMe talks about are caused by multiple genes (in combination with the environment). The interactions between these genes are often really complicated, and typically the number of genes involved is huge (and the actual contribution of each gene to risk is very small). This has made investigation a nightmare - even the most understood genetic diseases, we only know about say 10-20% of the genes that make up the genetic part of the risk, which may only be 40% of the total risk. So 23andMe sees you have 1 of the 100 genes that we identified as contributing to a disease. That means you have 1% of 20% of 40%, which is really nothing to get excited about. I know 23andMe tries to communicate this, but they are also trying to run a buisness. If they stood up and said 'yeah, we can do some tests, and they really won't tell you anything worth knowing', they would get no press coverage. But anything else is... carefully not lying, rather than being honest. I read other commenters here, who say things like 'Well it's a nice compliment to getting a blood test', and get the feeling they think these tests mean shit.
patrickmclaren 13y ago
My comment from the same story on reddit. For those protesting this decision, carefully read the following: > However, even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses that the firm identified in its submissions. In your letter dated January 9, 2013, you stated that the firm is “completing the additional analytical and clinical validations for the tests that have been submitted” and is “planning extensive labeling studies that will take several months to complete.” Thus, months after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS. It is now eleven months later, and you have yet to provide FDA with any new information about these tests. You have not worked with us toward de novo classification, did not provide the additional information we requested necessary to complete review of your 510(k)s, and FDA has not received any communication from 23andMe since May. Instead, we have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the PGS’s uses and consumer base without obtaining marketing authorization from FDA. It appears that 23andMe is and has been aware of this situation for quite some time. In fact, the FDA has devoted significant time to aiding 23andMe in their process to compliance: > As part of our interactions with you, including more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications, we provided you with specific feedback on study protocols and clinical and analytical validation requirements, discussed potential classifications and regulatory pathways (including reasonable submission timelines), provided statistical advice, and discussed potential risk mitigation strategies. The FDA in fact proposed a relatively simple solution, which was related to the labeling of the product. > FDA has spent significant time evaluating the intended uses of the PGS to determine whether certain uses might be appropriately classified into class II, thus requiring only 510(k) clearance or de novo classification and not PMA approval, and we have proposed modifications to the device’s labeling that could mitigate risks and render certain intended uses appropriate for de novo classification. Please keep in mind the scenarios in which the FDA attempts to avoid, in this situation. Particularly, a layman could consider their 23andMe results to be conclusive evidence for/against particular diseases and conditions, regardless of the respective error bounds for the data, and take matters into their own hands or simply prefer their results over the advice of medical professionals. Sure, there are T&C on 23andMe which state that this product should not be used in these purposes, this labeling is exactly what the FDA wants to improve. Limitations of assurance or intended use cases for products of this nature should be clearly labeled, and in a consistent manner. A startup (although 23andMe could be considered to be well beyond that stage) should not entrusted to make these decisions alone, and in fact, we do not have one such independent entity within this space, it is a growing arena within which multiple such entities are competing. It is not their business to care about other use cases, it is their business to stay in business. A particular paragraph on 23andMe's homepage says "Understand your genetic health risks. Change what you can, manage what you can't." I do see many individuals in the Nootropics/Quantified Self community interpreting their own results and indeed taking matters into their own hands. Okay, so perhaps these individuals may be of above average intelligence and are capable of behaving rationally, but this desire to improve oneself is not limited to our circle. Believe it or not, most of the population would love to improve in one aspect or another. We should be very careful in what 'gifts' we present to society, especially gifts of this nature.
rossjudson 13y ago
When I read the FDA press release, it states that 23andMe must cease marketing their product. I don't see where it says that they must stop selling it. If I'm right about that, they're free to continue selling the product but have to stop their public statements about it, until the FDA grants them leave to do so.

79 points by wikiburner 13y ago

Completely understandable and it's a fair point people might undergo unnecessary surgery as a result of a false positive (like having breast tissue removed preemptively after false positives for chances of contracting breast cancer). 23andMe is a nice idea, but you can't beat an old fashioned regular trip to the doctor and blood test to check for these things.

jfoster 13y ago
Unless 23andme start selling the surgery as well, doctors will be involved before any surgery happens.
gkoberger 13y ago
Think about the opposite, though -- most people don't get tested for anything, especially weird/uncommon conditions. Tests like 23andme aren't something your local doctor does every checkup. For $100, people who otherwise would have been clueless know if there's something they should ask their doctor about. In this case, I think some false positives are better than ignorance. Worst case, you think "oh no, I'm predisposed to ___!" for a few days until you make it to a doctor who can tell you for sure. It's fair to say 23andme has saved far more lives than it's hurt.
- mikevm 13y ago
  > It's fair to say 23andme has saved far more lives than it's hurt. Please back this statement with evidence, otherwise it's just hot air.
- felipe 13y ago
  > Tests like 23andme aren't something your local doctor does every checkup. Fair enough. So why not let FDA go through their process, do their investigation, and once approved people could safely rely on 23andme.
  - coryrc 13y ago
    We could write something untruthful or harmful in the newspaper (maybe about acai berry weight loss). So why not let the government go through a process, investigate whether what we write is conducive to the public good, and once approved it can be safely published.
dreamdu5t 13y ago
Just as there will be people who get surgery due to false positives (which happen with regulated testing too), there are lots of people who otherwise have no preferred means of testing if it's regulated away.
- teraflop 13y ago
  The FDA doesn't appear to be trying to shut down 23andMe, just trying to force them to file the appropriate documentation and follow the same rules as everyone else regarding how they advertise their services.
berberous 13y ago
The idea that someone is going to get their breast tissue removed based on 23andMe alone strikes me as unbelievable. A doctor would be consulted, who would likely order more appropriate diagnostic tests first. I would imagine any doctor that jumped straight into surgery based off of a 23andMe print out would eventually be sued for negligence.
- deleted 13y ago
  [deleted]

dangero 13y ago

Has 23andMe told their side of the story yet? The FDA's press release made it sound like 23andMe was very negligent, but there has to be more to it than that. I can't imagine a company just ignoring the FDA's requests.

fjarlq 13y ago
They posted this to Facebook: Hi everyone, Many of you have seen and been asking about this morning's news. Here's the statement we've issued to the media: "We have received the warning letter from the Food and Drug Administration. We recognize that we have not met the FDA's expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns." We'll continue to keep you updated here as we know more. Thanks for all the messages of support! https://www.facebook.com/23andMe/posts/10152374363517802 https://www.facebook.com/23andMe/posts/10152374363517802

bcl 13y ago

From the 23andme TOS: "You should not change your health behaviors solely on the basis of information from 23andMe. Make sure to discuss your Genetic Information with a physician or other health care provider before you act upon the Genetic Information resulting from 23andMe Services. For most common diseases, the genes we know about are only responsible for a small fraction of the risk. There may be unknown genes, environmental factors, or lifestyle choices that are far more important predictors. If your data indicate that you are not at elevated genetic risk for a particular disease or condition, you should not feel that you are protected. The opposite is also true; if your data indicate you are at an elevated genetic risk for a particular disease or condition, it does not mean you will definitively develop the disease or condition. In either case, if you have concerns or questions about what you learn through 23andMe, you should contact your physician or other health care provider." https://www.23andme.com/about/tos/ https://www.23andme.com/about/tos/

edmccard 13y ago
> From the 23andme TOS: > ... Make sure to discuss your Genetic Information ... before you act upon the Genetic Information The problems are not about what someone might do with their "Genetic Information", but with the accuracy of the "Genetic Information" in the first place. The false positives/false negatives mentioned in the FDA's warning letter[1] are not referring to misdiagnoses based on the 23AndMe's results, but to misidentification of genes in those results (as the letter describes it, "false genotype results") In a nutshell: 23AndMe claim that the genetic variants in their results are (to some degree of accuracy) genetic variants that you actually have; the FDA says that 23AndMe have not provided enough evidence for these claims. [1] http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376296.htm http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2...
Karunamon 13y ago
This is what I don't get. It's not like this is hidden. The site is completely upfront about what they are and what they do, what studies and results have more confidence and which less. Maybe I'm just a little cynical here, but it seems the FDA would have better things to do with their time. That in mind, I wonder what spurred this...

taspeotis 13y ago

Previous discussion https://news.ycombinator.com/item?id=6794122 https://news.ycombinator.com/item?id=6794122 317 points by jefffoster 14 hours ago | flag | cached | share | 377 comments

djjose 13y ago

The crux of their troubles comes from this paragraph in the Warning Letter: "However, even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses that the firm identified in its submissions. In your letter dated January 9, 2013, you stated that the firm is “completing the additional analytical and clinical validations for the tests that have been submitted” and is “planning extensive labeling studies that will take several months to complete.” Thus, months after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS. It is now eleven months later, and you have yet to provide FDA with any new information about these tests." The FDA, while being a pain in the rear at times, will actually work with you to meet compliance. But you have to show work and be continually in touch with them and show progress (and document everything according to your own procedures, complying to regulations of course). You can't just say you're working on compliance and then not follow through and show evidence. The issue for 23andMe is the on-label use of the product "in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body." They market the product this way. If you want to market your product as such, you have to show proof to the FDA and receive approval to label the medical product in this manner. It looks like 23andMe is either not working towards compliance (and is misleading the FDA) or is doing a terrible job documenting their work towards compliance and keeping the FDA abreast (my guess is this is what's happening). That in itself will get you in trouble, but then expanding your marketing for even more on-label use of the product - which hasn't been submitted to the FDA apparently - while at the same time not having FDA approval for the original use is just plain stupid.

dpe82 13y ago
I used to work as a state legislative aid; one of my duties was helping constituents work with state agencies on regulatory matters. I learned from that experience most regulators (at least at the state level, I imagine federal is similar) usually care much more about compliance than enforcement. As long as you aren't doing something egregious and make a good faith effort to work with them they'll often be pretty reasonable within the confines of the law. However if you ignore them, they'll come down on you like a ton of bricks. It sounds like 23andMe has been ignoring them.

Michael_Murray 13y ago

Of course this happens the week after I submit my sample.... ;-)

snitko 13y ago

FDA as always sticking their nose into something they shouldn't. Let the people decide whether they want to use this particular service or not. People ought to be free to choose. Otherwise it's not consumer protection, it's consumer dictatorship.

Angostura 13y ago
But it seems clear that it really shouldn't be used for anything in its current state.
thelambentonion 13y ago
This really looks like the FDA sticking their nose into something they should. 23andMe is making false claims about the efficacy of their test in their marketing material and the FDA isn't okay with that. They're not even ordering 23andMe to stop testing, just to stop marketing their service as something it isn't.

jacoblyles 13y ago

I'd rather see them shut down the FDA than 23andMe

cscurmudgeon 13y ago
I am not a big fan of possible snake oil even if it comes in hipster startup form.
- snitko 13y ago
  Great, don't use it then. Why do you believe you have the right to tell other people what to buy for their money?
  - consonants 13y ago
    Why do you believe the pursuit of profits trumps the democratic decisions of the people?
  - cscurmudgeon 13y ago
    >> Why do you believe you have the right to tell other people what to buy for their money? I am not doing that. The FDA is doing that. That is their job. If you disagree with that, you should also be okay with charlatans selling snake oil.
    - snitko 13y ago
      You are paying for it with your tax money, therefore you are doing it. I'm not okay with selling snake oil, but I think it is wrong to prevent other people from buying it. It's okay to inform them it's a bad idea to buy certain things - it's dictatorship to prevent them from doing so. If you can't convince somebody, it's your problem, not that person's problem. FDA doesn't convince, it just comes and shuts you down or doesn't allow you on the market. Besides, where is FDA when charlatans sell homeopathic medicine? Show me a little consistency here.
      - deleted 13y ago

shubb 13y ago

The problem with 23andmMe is that genetics can't currently tell us much about our risk of developing common genetic diseases. Some diseases are caused by a single gene. These are rare because people with a dominant copy of that gene are less likely to reproduce, so they are mostly deselected. Many of these monogenic diseases have a pretty major effect. You know if you have them (and probably died in childhood). Pre-natal genetic counseling is where finding these is useful. Most of the diseases 23andMe talks about are caused by multiple genes (in combination with the environment). The interactions between these genes are often really complicated, and typically the number of genes involved is huge (and the actual contribution of each gene to risk is very small). This has made investigation a nightmare - even the most understood genetic diseases, we only know about say 10-20% of the genes that make up the genetic part of the risk, which may only be 40% of the total risk. So 23andMe sees you have 1 of the 100 genes that we identified as contributing to a disease. That means you have 1% of 20% of 40%, which is really nothing to get excited about. I know 23andMe tries to communicate this, but they are also trying to run a buisness. If they stood up and said 'yeah, we can do some tests, and they really won't tell you anything worth knowing', they would get no press coverage. But anything else is... carefully not lying, rather than being honest. I read other commenters here, who say things like 'Well it's a nice compliment to getting a blood test', and get the feeling they think these tests mean shit.

patrickmclaren 13y ago

My comment from the same story on reddit. For those protesting this decision, carefully read the following: > However, even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses that the firm identified in its submissions. In your letter dated January 9, 2013, you stated that the firm is “completing the additional analytical and clinical validations for the tests that have been submitted” and is “planning extensive labeling studies that will take several months to complete.” Thus, months after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS. It is now eleven months later, and you have yet to provide FDA with any new information about these tests. You have not worked with us toward de novo classification, did not provide the additional information we requested necessary to complete review of your 510(k)s, and FDA has not received any communication from 23andMe since May. Instead, we have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the PGS’s uses and consumer base without obtaining marketing authorization from FDA. It appears that 23andMe is and has been aware of this situation for quite some time. In fact, the FDA has devoted significant time to aiding 23andMe in their process to compliance: > As part of our interactions with you, including more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications, we provided you with specific feedback on study protocols and clinical and analytical validation requirements, discussed potential classifications and regulatory pathways (including reasonable submission timelines), provided statistical advice, and discussed potential risk mitigation strategies. The FDA in fact proposed a relatively simple solution, which was related to the labeling of the product. > FDA has spent significant time evaluating the intended uses of the PGS to determine whether certain uses might be appropriately classified into class II, thus requiring only 510(k) clearance or de novo classification and not PMA approval, and we have proposed modifications to the device’s labeling that could mitigate risks and render certain intended uses appropriate for de novo classification. Please keep in mind the scenarios in which the FDA attempts to avoid, in this situation. Particularly, a layman could consider their 23andMe results to be conclusive evidence for/against particular diseases and conditions, regardless of the respective error bounds for the data, and take matters into their own hands or simply prefer their results over the advice of medical professionals. Sure, there are T&C on 23andMe which state that this product should not be used in these purposes, this labeling is exactly what the FDA wants to improve. Limitations of assurance or intended use cases for products of this nature should be clearly labeled, and in a consistent manner. A startup (although 23andMe could be considered to be well beyond that stage) should not entrusted to make these decisions alone, and in fact, we do not have one such independent entity within this space, it is a growing arena within which multiple such entities are competing. It is not their business to care about other use cases, it is their business to stay in business. A particular paragraph on 23andMe's homepage says "Understand your genetic health risks. Change what you can, manage what you can't." I do see many individuals in the Nootropics/Quantified Self community interpreting their own results and indeed taking matters into their own hands. Okay, so perhaps these individuals may be of above average intelligence and are capable of behaving rationally, but this desire to improve oneself is not limited to our circle. Believe it or not, most of the population would love to improve in one aspect or another. We should be very careful in what 'gifts' we present to society, especially gifts of this nature.

rossjudson 13y ago

When I read the FDA press release, it states that 23andMe must cease marketing their product. I don't see where it says that they must stop selling it. If I'm right about that, they're free to continue selling the product but have to stop their public statements about it, until the FDA grants them leave to do so.