23andMe bows to FDA, drops all medical information from new tests(arstechnica.com)
arstechnica.com
23andMe bows to FDA, drops all medical information from new tests
http://arstechnica.com/science/2013/12/23andme-bows-to-fda-drops-all-medical-information-from-new-tests/
10 comments
Because 23andMe can't run a disclaimer like that without being either:
- totally disingenuous
- defeating the core marketing angle of their product
Either they are issuing the disclaimer in good faith, in which case their marketing becomes "we don't really know for sure, this is just a for-fun thing, do not base any health decisions off this". This is antithetical to what 23andMe is trying to do.
Or they issue the disclaimer in bad faith - i.e., they claim certainty in their information, they claim reliability, and they market the product as a medical tool, and then slap a shitty disclaimer on the bottom like the small-print of a crappy infomercial purely for legal reasons.
The latter approach is just creative mislabeling, like calling vibrators massagers.
- totally disingenuous
- defeating the core marketing angle of their product
Either they are issuing the disclaimer in good faith, in which case their marketing becomes "we don't really know for sure, this is just a for-fun thing, do not base any health decisions off this". This is antithetical to what 23andMe is trying to do.
Or they issue the disclaimer in bad faith - i.e., they claim certainty in their information, they claim reliability, and they market the product as a medical tool, and then slap a shitty disclaimer on the bottom like the small-print of a crappy infomercial purely for legal reasons.
The latter approach is just creative mislabeling, like calling vibrators massagers.
I was listen to an old episode of Radio lab (http://www.radiolab.org/story/91713-famous-tumors/) and they had an ad for 23andme. The ad most talked about how you can use this information and talk it over with doctor. The ancestry reports was just a side thing mentioned at the end.
If you think 23andMe is getting singled out in comparison to homeopathy, that's not correct. The FDA has long considered how to handle homeopathic remedies, and they do regulate them and the conditions under which they can be marketed.
For more information, visit the NIH website: http://nccam.nih.gov/health/homeopathy#hed6
Note that homeopathic medicines cannot be sold over the counter if they claim to treat a serious disease (something that wouldn't resolve on its own, like a cold or a headache). They must be prescribed!
For more information, visit the NIH website: http://nccam.nih.gov/health/homeopathy#hed6
Note that homeopathic medicines cannot be sold over the counter if they claim to treat a serious disease (something that wouldn't resolve on its own, like a cold or a headache). They must be prescribed!
Does 23andme claim to treat diseases? Not that I know of.
Next week:
Show HN: Saliva Road -- genomics as a Tor hidden service. We accept Bitcoins!
-DreadPostdocRoberts
Show HN: Saliva Road -- genomics as a Tor hidden service. We accept Bitcoins!
-DreadPostdocRoberts
Somehow I feel safer with a random pirate having my DNA in a database than Google.
It probably is safer in that, you will pretty much assume it will be use for nefarious purposes eventually. So going in you probably have the right mind set to protect yourself.
I'd like to announce here to HN before the rest of the world my new service: the Twitter of personal genomes. It will publish all the data to the web. No expectation of privacy? No problem! I will call it genr.
A hidden service bitcoin accepting DNA service presumably gives their clients anonymity right? So long as the DNA cannot be readily connected to my 'real' identity, I don't see much problem with anybody having it.
I mean, say they straight up sell it to insurance companies... now insurance companies know that some guy, somewhere, has [pre-existing condition here]. So long as they can't disambiguate "some guy", is there a problem for me? I could see myself opting into that sort of situation.
I mean, say they straight up sell it to insurance companies... now insurance companies know that some guy, somewhere, has [pre-existing condition here]. So long as they can't disambiguate "some guy", is there a problem for me? I could see myself opting into that sort of situation.
I wonder if your results are unique enough to be identifying. Also, there are legal protections (in the US) for health insurance, but not for life insurance.
Hmm, could be. If you start playing the 'bits of identifying information' game with DNA, I think it is conceivable that an insurance company (who already knows much about you) could narrow it down. That depends on how much they already know about you I suppose.
That's an "interesting" idea: Google Ads targeted for your genome.
Well, this makes the fact that I asked for this for Christmas awkward AND useless...
My sentiment exactly. 2 days ago I put it on my wishlist, reasoning that even if they weren't marketing, the results would still be interesting. What if I get a kit now? Do I manually look up everything in SNPedia or something?
I have an unused kit from the 99$ sale years ago... Crap. Will they still provide all of the data? One could create a 3rd party service to give the same analysis?
From their FAQ:
I purchased a kit as a gift before November 22nd, but have not given it to the recipient. Will they still receive health results when they send it in? Yes. Access to health-related results is based on the purchase date of the kit. Any kit purchased before November 22, 2013 and returned to our lab will receive health-related results.
That being said, aren't the kits only good for a year?
I purchased a kit as a gift before November 22nd, but have not given it to the recipient. Will they still receive health results when they send it in? Yes. Access to health-related results is based on the purchase date of the kit. Any kit purchased before November 22, 2013 and returned to our lab will receive health-related results.
That being said, aren't the kits only good for a year?
No need to do it manually: use promethease, for instance. Still, it's quite inconvenient.
I think it's interesting that they are still selling the kits at the $99 price point. They also haven't removed the health tab from their site. I'm guessing what they are doing is buying themselves time to prepare and discuss with the FDA. They might continue to run all the same SNPs on their already-designed chips and just try to justify to the FDA that those SNPs are medically relevant in the ways 23andMe says they are.
I heard about a service called Promethease[1] that will apparently give you some in-depth reporting as well as risk levels for disease. It may be of interest to you.
[1] https://promethease.com/ondemand
[1] https://promethease.com/ondemand
I found the ancestry information for more interesting than the medical part. So all may not yet be lost.
Unfortunately the differences genetically between different groups, aka ancestry, is less than the differences between individuals in the same group, so the medical part is what is interesting.
to you
They need to buckle down, work with the FDA and fully recognize the gravity of the information they are presenting to people. I can't imagine that they won't be able to do this.
Obviously most of the blame goes to the FDA here. The only problem I have with 23andMe's handling of the situation is that they continued to sell kits after November 22 promising that health information would be available and then retroactively removing that part of the service. I ordered the kit one day before they announced this, so I guess as soon as it arrives it's going back in the mail for a refund. They should have immediately removed the promise of health information on November 22.
Why does most of the blame go to the FDA? From their complaint:
> More than five 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 [testing service]," the letter states. It also says that in January 2013, 23andMe claimed that it was doing further testing for its approval application, testing that would take several months to complete; nearly a year later, it never submitted the results of the testing.
> More than five 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 [testing service]," the letter states. It also says that in January 2013, 23andMe claimed that it was doing further testing for its approval application, testing that would take several months to complete; nearly a year later, it never submitted the results of the testing.
Because the FDA is the one who ultimately wants this removed, and because by default most of society operates without seeking permission from the government to do anything.
And maybe because the FDA is stupid and thinks that the risk of people maybe finding out something inaccurate and going crazy with it is higher than the reward of people finding out something accurate and taking action to preserve their health based on this information. Ignorance is the only safe option!
And maybe because the FDA is stupid and thinks that the risk of people maybe finding out something inaccurate and going crazy with it is higher than the reward of people finding out something accurate and taking action to preserve their health based on this information. Ignorance is the only safe option!
All sorts of things require permission from the government. You can't even sell meat without a USDA inspection at some point in the process. The idea that a modern company could reasonably expect to sell medical diagnostic services without working with the FDA is silly.
I think that this is actually a very complex issue, and the part that more informed people are finding problematic isn't that people are regulating 23andme at all. There are lots of genetic laboratories in the US where you can send in a sample of DNA and they'll tell you things like that you've got the G:A or A:A variant of Rs601338. A laboratory that does stuff like that is covered under CLIA[1], administered by CLS which like the FDA is part of the DHHS.
The FDA's theory here, though, is that since 23andme goes beyond just saying "You have the G:A variant of Rs601338" to "You are probably as susceptible to norovirus infection as a typical person" they're not just a medical laboratory but also a medical device manufacturer, and therefore come under the FDA's purview with much stricter tests for what they can market and what sort of tests their product undergoes.
To me, that sounds pretty ridiculous since you can easily just go on SNPedia to look up the associated information yourself[2].
[1]http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA... [2]http://snpedia.com/index.php/Rs601338
The FDA's theory here, though, is that since 23andme goes beyond just saying "You have the G:A variant of Rs601338" to "You are probably as susceptible to norovirus infection as a typical person" they're not just a medical laboratory but also a medical device manufacturer, and therefore come under the FDA's purview with much stricter tests for what they can market and what sort of tests their product undergoes.
To me, that sounds pretty ridiculous since you can easily just go on SNPedia to look up the associated information yourself[2].
[1]http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA... [2]http://snpedia.com/index.php/Rs601338
You realize that SNPedia is basically the equivalent of Wikipedia for SNPs, and I can edit it to say whatever I want?
Would you want a physician picking your drug regimen based off of what Wikipedia says on some particular day? Would you like your implanted defibrillator to change its algorithm based on something Wikipedia says?
If not, then you've discovered the crux of the issue. There's a bright line between "data that someone put online yesterday" and "rigorously tested and proven effective". That's the whole point of FDA regulation on what gets to be marketed as a medical device, or what drugs can be prescribed for an indication.
Would you want a physician picking your drug regimen based off of what Wikipedia says on some particular day? Would you like your implanted defibrillator to change its algorithm based on something Wikipedia says?
If not, then you've discovered the crux of the issue. There's a bright line between "data that someone put online yesterday" and "rigorously tested and proven effective". That's the whole point of FDA regulation on what gets to be marketed as a medical device, or what drugs can be prescribed for an indication.
They didn't ask for it to be removed... they asked (repeatedly) for proof that it does what 23 claims it does.
Well, they eventually demanded 23andMe stop marketing it when they failed after an extended period to either provide support or even provide a plan for gathering the required support. But that wasn't the starting point.
> the risk of people maybe finding out something inaccurate and going crazy with it is higher than the reward of people finding out something accurate and taking action to preserve their health based on this information
I don't think this balance is as cut and dry as you claim it to be. There are very few "actionable" results that you can get from a 23andMe test right now, whatever they say to the contrary. The meat of the report that they currently provide is a list of alleles and associations to various properties, but there are thousands of alleles (and likely millions more not tested for lack of known associations) that sum to your particular phenotype. The math and science behind that summing process is severely lacking at this point, simply because we have not characterized the billions of interactions between them.
The FDA's problem with 23andMe is that they are not properly communicating this uncertainty in their marketing. Relevant to this issue is whether the reports can be called "medical" information or not. In order for things to live up to the standard of "medical" devices or therapies in the US, they have to pass a certain measure of QC, accuracy, and demonstrated efficacy. 23andMe hasn't done the legwork for any such tests, and from most accounts, it seems like the FDA has given ample effort to accommodate them so far.
This is not about hiding data from ignorant people. 23andMe will likely go on testing and providing reports. It just can't advertise it as "medical" until it passes the same standards as other medical products, just the same way I can't sell "Grade A" Beef unless it passes certain standards, or sell "bourbon" in the US unless it's aged in a charred-oak barrel. That is because we've decided as a society to link certain labels with standards, and the label would be pointless if it weren't applied consistently.
I don't think this balance is as cut and dry as you claim it to be. There are very few "actionable" results that you can get from a 23andMe test right now, whatever they say to the contrary. The meat of the report that they currently provide is a list of alleles and associations to various properties, but there are thousands of alleles (and likely millions more not tested for lack of known associations) that sum to your particular phenotype. The math and science behind that summing process is severely lacking at this point, simply because we have not characterized the billions of interactions between them.
The FDA's problem with 23andMe is that they are not properly communicating this uncertainty in their marketing. Relevant to this issue is whether the reports can be called "medical" information or not. In order for things to live up to the standard of "medical" devices or therapies in the US, they have to pass a certain measure of QC, accuracy, and demonstrated efficacy. 23andMe hasn't done the legwork for any such tests, and from most accounts, it seems like the FDA has given ample effort to accommodate them so far.
This is not about hiding data from ignorant people. 23andMe will likely go on testing and providing reports. It just can't advertise it as "medical" until it passes the same standards as other medical products, just the same way I can't sell "Grade A" Beef unless it passes certain standards, or sell "bourbon" in the US unless it's aged in a charred-oak barrel. That is because we've decided as a society to link certain labels with standards, and the label would be pointless if it weren't applied consistently.
There are cases when you're wrong: ignorance is better than very, very, very severe information without context. I chose not to view whether I have risk for Alz, Parkinson's, and carry BRCA because I will not be able to process that information, as a human, and I can't act on it anyway - all it can do is harm me.
Because I'm being downvoted, I feel the need to take a stronger stance: sometimes, information is more harmful to a person because we do not always act well on it.
Because I'm being downvoted, I feel the need to take a stronger stance: sometimes, information is more harmful to a person because we do not always act well on it.
I find this perspective interesting. What information about yourself do you think you would act badly on if it were made available to you? And who would you trust to make the decision about withholding information, and to not abuse their authority?
Thank you for asking.
I decided not to view information about Alzheimer's and Parkinson's because the abnormality they reveal is a genetic variant that you cannot, like, read crossword puzzles to avert. It's just bad news. If I find out that I don't have the variants then all I've done is crossed two variants of two diseases of thousands. It's not worth the spin of the roulette wheel.
Normally this would be revealed by a genetic counselor and context given. Personally, I wouldn't view this information no matter what.
BRCA is another issue. I think BRCA is _very_ important information, since a mastectomy and possible hysterectomy can greatly reduce chances of the resulting cancer. But this information needs to be given with immediate context and guidance, and now how 23andme presents it.
I was also kind of astounded that 23andme doesn't even prompt you whether or not you want to find out if you're a Tay-Sach's carrier or not. That can be enormously significant news. I turn out to have the variant that tends to test false positive, but I was still unhappy to be given that information without my prompt.
I decided not to view information about Alzheimer's and Parkinson's because the abnormality they reveal is a genetic variant that you cannot, like, read crossword puzzles to avert. It's just bad news. If I find out that I don't have the variants then all I've done is crossed two variants of two diseases of thousands. It's not worth the spin of the roulette wheel.
Normally this would be revealed by a genetic counselor and context given. Personally, I wouldn't view this information no matter what.
BRCA is another issue. I think BRCA is _very_ important information, since a mastectomy and possible hysterectomy can greatly reduce chances of the resulting cancer. But this information needs to be given with immediate context and guidance, and now how 23andme presents it.
I was also kind of astounded that 23andme doesn't even prompt you whether or not you want to find out if you're a Tay-Sach's carrier or not. That can be enormously significant news. I turn out to have the variant that tends to test false positive, but I was still unhappy to be given that information without my prompt.
These are good examples of information that you rationally choose not to learn. The second part of my question was whether you believe some third party should be able to require that the information be withheld from you even if you want to learn it.
Clearly I do believe that information should be regulated, since I support FDA's ban of 23andme disseminating statistically inconfident yet severe medical information the way they do. Because of the way people react to it, I do not think that this information should be given without genetic counsel.
This is the only case in my life where I've thought that a piece of information should be regulated.
The phrase "information regulation" is deeply scary to me. This is dangerous turf. But I think that this is the right decision at the time.
This is the only case in my life where I've thought that a piece of information should be regulated.
The phrase "information regulation" is deeply scary to me. This is dangerous turf. But I think that this is the right decision at the time.
> Because the FDA is the one who ultimately wants this removed,
The FDA wanted it removed or justified -- assuring this with regard to medical devices is one of the things FDA is charged by Congress with doing. So, unless you can point to how the FDA isn't doing what it is charged to do, the blame either goes to 23andMe or to Congress, depending on how view the appropriateness of Congress's charge to the FDA.
The FDA wanted it removed or justified -- assuring this with regard to medical devices is one of the things FDA is charged by Congress with doing. So, unless you can point to how the FDA isn't doing what it is charged to do, the blame either goes to 23andMe or to Congress, depending on how view the appropriateness of Congress's charge to the FDA.
That's not exactly correct. The FDA creates its own regulations. It doesn't just follow laws passed by Congress.
> That's not exactly correct.
Yes, it is.
> The FDA creates its own regulations. It doesn't just follow laws passed by Congress.
It creates regulations (and enforces them) as a means to executing the role Congress has given it. So, again, if you don't have an argument for how what the FDA is doing is inconsistent with the statutory purpose it has been given by Congress, your beef is with Congress, not the FDA.
Yes, it is.
> The FDA creates its own regulations. It doesn't just follow laws passed by Congress.
It creates regulations (and enforces them) as a means to executing the role Congress has given it. So, again, if you don't have an argument for how what the FDA is doing is inconsistent with the statutory purpose it has been given by Congress, your beef is with Congress, not the FDA.
> because by default most of society operates without seeking permission from the government to do anything
So I take it you don't drive, don't own a residence, don't have a bank account, don't own a business, ...?
So I take it you don't drive, don't own a residence, don't have a bank account, don't own a business, ...?
Why is the Food and Drug Administration sticking it's nose into what is essentially a novelty product? Are you kidding me?
If only 23andme had a pair of balls ... this should really end up in court where we can clearly draw a line the FDA can't cross.
If only 23andme had a pair of balls ... this should really end up in court where we can clearly draw a line the FDA can't cross.
> Why is the Food and Drug Administration sticking it's nose into what is essentially a novelty product?
Because it was being marketed as a health product, not a novelty product.
Because it was being marketed as a health product, not a novelty product.
So maybe they should rename themselves to the Consumer Protection Admini... oh wait, naming conflict. Oops.
When I said "the FDA," I really meant the entire legal and regulatory system that puts these silly limitations on a harmless product like 23andMe's DNA test.
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I guess I will be making screenshots of all the health information in my 23andme account now. Who knows if they'll be allowed to keep it up there indefinitely?
I don't yet have one. Is there not a way to download your information? They should certainly allow some sort of export.
I have an account. You can export your raw data from the test. I've done so and actually taken my results to other services for additional analyses. You can't, however, easily download their interpretations of your results, which is fair since that's their website. I did actually take the time to go page by page through their analysis and print them to pdfs.
If you're interested, I did a write-up on everything I've learned through personal genomics with resources, etc:
http://ideonexus.com/2012/04/16/adventures-in-personal-genom...
If you're interested, I did a write-up on everything I've learned through personal genomics with resources, etc:
http://ideonexus.com/2012/04/16/adventures-in-personal-genom...
Prior discussion from last night...
https://news.ycombinator.com/item?id=6859732
https://news.ycombinator.com/item?id=6859732
I purchased and sent in my kit before they removed medical information from their website. However, it hasn't processed yet. I expected that medical information (even though I knew not to trust it). What an awkward position.
I'm in the same position, although I returned my kit before the November 22 cutoff date. I figure I could probably request a refund given the new FDA situation -- given their regulatory situation, they'll probably loosen their refund policy to avoid compounding matters. But I don't think my kit should have any less information than before, so I figured I'd let it play out and see what the results look like. Obviously if my results don't include health data, then I'll certainly ask for a refund, because that was the main reason I enrolled.
If they continue to not process the health information, I bet they will offer some sort of plan to mitigate the horrible PR from the nightmare that would ensue if they don't. I heard a seminar from one of the VPs and she made it seem like they don't run those chips at a very high margin, so this might set them back a bit, but I think the future is in their favor.
Yeah, me too. The primary reason I purchased this is that I know I have 50% odds of having a BRCA mutation (1 of my parents does). I was really looking forward to that test.
This is exactly why the FDA is acting correctly here!
Dig deep on the 23andme website and you'll find that they test for a few BRCA mutations, but not all. It's far from comprehensive, and it's not at all equivalent to a normal test that you would get from a doctor. From https://customercare.23andme.com/entries/23241132-Does-the-2... "The BRCA Cancer Mutations (Selected) report includes 3 selected BRCA mutations. The BRCA mutations covered by this report are only three of hundreds in the BRCA1 and BRCA2 genes that can cause cancer."
I've seen several commenters here on HN making the same mistake as you. HN readers are generally smart and skeptical. If we aren't perceptive enough to see through the bullshit, how do you think the general public is going to fare?
Dig deep on the 23andme website and you'll find that they test for a few BRCA mutations, but not all. It's far from comprehensive, and it's not at all equivalent to a normal test that you would get from a doctor. From https://customercare.23andme.com/entries/23241132-Does-the-2... "The BRCA Cancer Mutations (Selected) report includes 3 selected BRCA mutations. The BRCA mutations covered by this report are only three of hundreds in the BRCA1 and BRCA2 genes that can cause cancer."
I've seen several commenters here on HN making the same mistake as you. HN readers are generally smart and skeptical. If we aren't perceptive enough to see through the bullshit, how do you think the general public is going to fare?
Are the BRCA genetics well enough understood that a deep sequence of that gene is able to be adequately interpreted?
Ultimately, what you seem to be suggesting is that it is better that we not get partial data because most people won't understand that it's partial data and further won't know what to do with it. Most people are not geneticists. I sort of agree, but there is no doubt in my mind that the future will see the loosening of the physician-as-gatekeeper, and to what extent is that acceptable. Would this service be allowed if they taught cursory genetics and SNPs in the general biology curricula at the high school level?
Ultimately, what you seem to be suggesting is that it is better that we not get partial data because most people won't understand that it's partial data and further won't know what to do with it. Most people are not geneticists. I sort of agree, but there is no doubt in my mind that the future will see the loosening of the physician-as-gatekeeper, and to what extent is that acceptable. Would this service be allowed if they taught cursory genetics and SNPs in the general biology curricula at the high school level?
Are the BRCA genetics well enough understood that a deep sequence of that gene is able to be adequately interpreted?
It's not my field, but I know they're well enough understood that you can get far more information from the full sequence than from a few SNPs. Even 23andme has always said the same thing on their website if you look closely.
Ultimately, what you seem to be suggesting is that it is better that we not get partial data because most people won't understand that it's partial data and further won't know what to do with it.
I wouldn't quite say that. I think partial data is perfectly fine. I'm a 23andme customer, despite understanding that it's close to meaningless from a medical perspective (I think the most valuable medical information I got was related to male pattern baldness; coolest information is the Neanderthal stuff). The problem IMHO was 23andme's marketing, which to me seemed almost as if it was designed to mislead people.
Another example... over thanksgiving I was talking to my cousin. She brought up the 23andme news because she had recently done it, but hadn't received results yet. I asked her why she got the test. First answer? BRCA. She had no idea that the 23andme test was not nearly comprehensive. And she's not just some average person not smart enough to understand things - she has a PhD from MIT (albeit not in biology, although her husband has a biology PhD), knows a lot about breast cancer since her mom had it, and is generally very cynical about stuff like this.
Would this service be allowed if they taught cursory genetics and SNPs in the general biology curricula at the high school level?
I think high school curricula are irrelevant to the discussion, for multiple reasons. The vast majority of high school students don't have the background to understand this stuff. Even if they did, most wouldn't care enough to remember it. And even if they did care, the science is changing rapidly - it won't be too long before we're doing whole genomes and many other things.
It's not my field, but I know they're well enough understood that you can get far more information from the full sequence than from a few SNPs. Even 23andme has always said the same thing on their website if you look closely.
Ultimately, what you seem to be suggesting is that it is better that we not get partial data because most people won't understand that it's partial data and further won't know what to do with it.
I wouldn't quite say that. I think partial data is perfectly fine. I'm a 23andme customer, despite understanding that it's close to meaningless from a medical perspective (I think the most valuable medical information I got was related to male pattern baldness; coolest information is the Neanderthal stuff). The problem IMHO was 23andme's marketing, which to me seemed almost as if it was designed to mislead people.
Another example... over thanksgiving I was talking to my cousin. She brought up the 23andme news because she had recently done it, but hadn't received results yet. I asked her why she got the test. First answer? BRCA. She had no idea that the 23andme test was not nearly comprehensive. And she's not just some average person not smart enough to understand things - she has a PhD from MIT (albeit not in biology, although her husband has a biology PhD), knows a lot about breast cancer since her mom had it, and is generally very cynical about stuff like this.
Would this service be allowed if they taught cursory genetics and SNPs in the general biology curricula at the high school level?
I think high school curricula are irrelevant to the discussion, for multiple reasons. The vast majority of high school students don't have the background to understand this stuff. Even if they did, most wouldn't care enough to remember it. And even if they did care, the science is changing rapidly - it won't be too long before we're doing whole genomes and many other things.
>This is exactly why the FDA is acting correctly here!
No, it's not. None of the actual genetic testing is going to stop, only interpretation.
No, it's not. None of the actual genetic testing is going to stop, only interpretation.
I didn't say anything about problems with their genetic testing (heck, I bought it myself), just with their marketing and interpretation. Those are the things that are now on pause.
You said that testing for BRCA variants was an example of what the FDA was acting on, didn't you? I'm not sure how else to interpret that first line.
This is exactly why the FDA is acting correctly here!
By "this" I meant "people not understanding the massive limitations in what 23andme does, likely due to their misleading and overhyped marketing material".
Rereading my post, I can see how that might not have come across as I originally intended.
By "this" I meant "people not understanding the massive limitations in what 23andme does, likely due to their misleading and overhyped marketing material".
Rereading my post, I can see how that might not have come across as I originally intended.
For what it's worth, my info is still visible so it might be possible that it'll be up for you too by the time sequencing is done.
So... opensource tool for healthy interpretation of raw data from 23andme? Anyone?
If Valley folks created this, it would be the holy grail that NIH-funded bioinformatics researchers have been pursuing for the last 20 years. I wish them the best!
In all seriousness, this is exactly the point of most federally funded research in genomics, including the projects of the institute I work for. http://icahn.mssm.edu/genomics
In all seriousness, this is exactly the point of most federally funded research in genomics, including the projects of the institute I work for. http://icahn.mssm.edu/genomics
How come they try to make these guys shut down, but largely leave homeopathy alone? I would say homeopathy is way more damaging than seeing whats in your genes.
Why does the FDA have to be jerks? (that's rhetorical. I know why they have to be jerks. It just sucks.)