Google-Backed 23andMe Ordered to Halt DNA Test Service

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FDA approval? We don't need no stinking FDA approval! Wait, we do? Whoops. :eek:

23andMe Inc., the Google Inc.-backed DNA analysis company co-founded by Anne Wojcicki, was told by U.S. regulators to halt sales of its main product because it’s being sold without “marketing clearance or approval.” “FDA is concerned about the public health consequences of inaccurate results from the PGS device,” the agency said today. “The main purpose of compliance with FDA’s regulatory requirements is to ensure that the tests work.”
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Fail to receive PMA, but go to market anyway? The FDA will shut you down so fast, fine you, and make it a legal and regulatory nightmare to ever get off the ground again.
 
It would be neat if Google could link your DNA to your browsing habits to bolster their advertising profile for you.
 
Dear FDA, please show the same level of concern re the safety of GMO foodstuffs.

Thank you.
 
So need FDA approval because it's considered a "medical device" as far as telling you information about yourself? I guess all those blood pressure devices in stores also have FDA approval? How about Dr Scholls machine that tells you what inserts you need? Does the doctor have FDA approval that completely missed the skin cancer? Or told me that I had X-months to live and fucked that up too? (last two are hypotheticals)
 
23andMe use the same machines as crime scene labs, and they are saying they don't know if this machines are accurate? I bloody well hope they do.
 
The hold up is the utter terror our government has regarding the number of women and kids that will suddenly be on public assistance. Make DNA tests that easy, and you are going to have "fathers" find out their kids aren't theirs. They are going to walk, and even though the laws in some states can compel child support regardless of parentage, those that support those laws will quickly find themselves at the wrong end of the beta male voter block. There is a reason France made such paternity tests illegal.
 
sfsuphysics said:
So need FDA approval because it's considered a "medical device" as far as telling you information about yourself? I guess all those blood pressure devices in stores also have FDA approval? How about Dr Scholls machine that tells you what inserts you need? Does the doctor have FDA approval that completely missed the skin cancer? Or told me that I had X-months to live and fucked that up too? (last two are hypotheticals)
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Yes, the blood pressure cuffs all need FDA approval via a 510(k) before legally being sold in this country.

This is a medical device as it processes DNA through saliva, then tries to predict illness and shows trends on how your body may or may not react to prescription drugs.
 
GORANKAR said:
The hold up is the utter terror our government has regarding the number of women and kids that will suddenly be on public assistance. Make DNA tests that easy, and you are going to have "fathers" find out their kids aren't theirs. They are going to walk, and even though the laws in some states can compel child support regardless of parentage, those that support those laws will quickly find themselves at the wrong end of the beta male voter block. There is a reason France made such paternity tests illegal.
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This isn't a paternity test machine, Maury.
 
Government_HeretoHelp1.jpg
 
cageymaru said:
It would be neat if Google could link your DNA to your browsing habits to bolster their advertising profile for you.
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I thought about that too. How soon until Google sells the DNA profile (probably in the EULA) to the government so they can search crimes against it?

I love the idea of the test, always wanted to a complete DNA workup just to see origins/etc. - but the idea of Google having it scares the hell out of me. It'd probably be worth it to go with the more expensive anonymous labs that just take the DNA but don't link it to a profile.
 
sfsuphysics said:
So need FDA approval because it's considered a "medical device" as far as telling you information about yourself? I guess all those blood pressure devices in stores also have FDA approval? How about Dr Scholls machine that tells you what inserts you need? Does the doctor have FDA approval that completely missed the skin cancer? Or told me that I had X-months to live and fucked that up too? (last two are hypotheticals)
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There's a big difference between telling you your blood pressure is possibly high and telling you you have a higher risk of sensitivity to particular drugs or a higher risk of certain types of cancer.
 
sfsuphysics said:
So need FDA approval because it's considered a "medical device" as far as telling you information about yourself? I guess all those blood pressure devices in stores also have FDA approval? How about Dr Scholls machine that tells you what inserts you need? Does the doctor have FDA approval that completely missed the skin cancer? Or told me that I had X-months to live and fucked that up too? (last two are hypotheticals)
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They're just afraid that some dumbass is going to overreact and self medicate because their DNA test shows they have a slightly greater chance of something than average and end up killing themselves. But frankly if you're that dumb, we don't need you in the gene pool.
 
LeninGHOLA said:
This is a medical device as it processes DNA through saliva, then tries to predict illness and shows trends on how your body may or may not react to prescription drugs.
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The commercials themselves have a disclaimer that this is for informational purposes only and isn't meant to replace medical advice.

I mean there's probably a lot more people using palm readers and other "psychics" for medical advice but there's no crack down on them.

As mentioned they use similar machines (the same?) as crime labs use, shouldn't the company they bought them from basically have the FDA approval which should carry over to them.
 
Dwango said:
They're just afraid that some dumbass is going to overreact and self medicate because their DNA test shows they have a slightly greater chance of something than average and end up killing themselves. But frankly if you're that dumb, we don't need you in the gene pool.
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Ahem... Angelina Jolie... ;)
 
sfsuphysics said:
The commercials themselves have a disclaimer that this is for informational purposes only and isn't meant to replace medical advice.

I mean there's probably a lot more people using palm readers and other "psychics" for medical advice but there's no crack down on them.

As mentioned they use similar machines (the same?) as crime labs use, shouldn't the company they bought them from basically have the FDA approval which should carry over to them.
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I'm not in favor of over-regulation, I'm just telling you how the FDA works. It's a medical device and falls under their regulatory jurisdiction. The FDA is a huge pain to work with if they think there might be an issue, right or not.

They are using their own machines based on their own designs, as far as I know.
 
LeninGHOLA said:
Fail to receive PMA, but go to market anyway? The FDA will shut you down so fast, fine you, and make it a legal and regulatory nightmare to ever get off the ground again.
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She was married to a liberal shill so they didn't need PMA. No longer married to Democrat/Liberal shill campaign donator? Opps, where is that PMA Missy? Don't got it? Time to close those doors.
 
sfsuphysics said:
The commercials themselves have a disclaimer that this is for informational purposes only and isn't meant to replace medical advice.

I mean there's probably a lot more people using palm readers and other "psychics" for medical advice but there's no crack down on them.

As mentioned they use similar machines (the same?) as crime labs use, shouldn't the company they bought them from basically have the FDA approval which should carry over to them.
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There is a more to this than the equipment. How do they store the samples, how do they test them, does the person using the equipment know how to correctly us it....

One of my boss's side businesses is a company trying to work on treatments for cancer. I had to go help setup their network for FDA approval. They had to have certain security processes in place (which really aren't anything special). They had to make sure to keep medical information secure, they have to show that they are keeping the samples stored correctly, have to show how they test everything....

I wouldn't expect this to be much different. They are getting blood samples from people, probably other information from people (SSN?) and so I could see them needing to make sure to have certain things in place.
 
Exavior said:
There is a more to this than the equipment. How do they store the samples, how do they test them, does the person using the equipment know how to correctly us it....

One of my boss's side businesses is a company trying to work on treatments for cancer. I had to go help setup their network for FDA approval. They had to have certain security processes in place (which really aren't anything special). They had to make sure to keep medical information secure, they have to show that they are keeping the samples stored correctly, have to show how they test everything....

I wouldn't expect this to be much different. They are getting blood samples from people, probably other information from people (SSN?) and so I could see them needing to make sure to have certain things in place.
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I still don't get why this is an FDA thing and not a FTC thing as far as accuracy goes. Yeah they are doing "medical procedures" they're looking at DNA, they are not prescribing medicine, they are not giving advice on what to do with your results, they're basically taking a picture of your genome and pointing out what all the different parts mean.

By all accounts that little kiosk in the mall that does a family tree for you should required to get FDA approval since you can use that information to link to potential genetic issue (health or otherwise... like baldness)
 
LeninGHOLA said:
I'm not in favor of over-regulation, I'm just telling you how the FDA works. It's a medical device and falls under their regulatory jurisdiction.
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How is a medical device defined by law (or whatever the judge thinks at the moment)? I would consider a medical device something that you physically use on a human. Is a computer that tests a urine sample considered a medical device?

At any rate, seems kind of far reaching for the _Food_ and _Drug_ Administration.
 
I have worked for both pharma and forensics labs, there's much more to it than the equipment as mentioned above. Hell anyone can buy equipment. In this case the FDA has a point because let's face it people are stupid. Especially since people associate Google with benign innovation. Now imagine if the company were funded by the Chinese, people would be screaming for every agency in the land. End of the day compliance with FDA regulations is really not that difficult, there were just naive or just too greedy.
 
It seems to me that a DNA test on spit has less harmful potential than dietary supplements do. 23&Me and Google need to get to hiring themselves some current and future FDA employees.
 
Why don't they call their service a "palm reading" service but every time its used it "accidently" pokes your palm and blood "happens to fall out" and then gets scanned for some reason... :D
 
Smell like big pharmaceutical companies are scared of this Google service, and with their government, they are preventing it from reducing their market share. Squashing it.
 
There is something the government is not telling us, since any time an organization has tried gathering this data outside of the US military, they have met all kinds of road blocks. Clearly someone is not comfortable with an unregulated group knowing what is leading causes of genetic illness.

I say let them get the test but have to have it sent to a doc to explain it. Or have a genetic scientist sign off on what traits they see. As far as security goes it is the same HIPA requirements any other medical data requires.
 
Kalabalana said:
Smell like big pharmaceutical companies are scared of this Google service, and with their government, they are preventing it from reducing their market share. Squashing it.
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No way, know you have 34.3243% chance to get cancer before age 102, well take Cureitall that will help lower that value to 32.3243% from the makers of Fuckitall, a Pfizer product.
 
MRAB54 said:
How is a medical device defined by law (or whatever the judge thinks at the moment)? I would consider a medical device something that you physically use on a human. Is a computer that tests a urine sample considered a medical device?

At any rate, seems kind of far reaching for the _Food_ and _Drug_ Administration.
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Anything that is used in a diagnostic process generally counts. Monitors used to display X-Rays/CTs/etc count, since they are used for diagnosis. Same with the workstations connected to said monitors, and the servers that store and process the images. Mammography monitors are extra fun. The FDA is quite far reaching for some things.
 
LeninGHOLA said:
Fail to receive PMA, but go to market anyway? The FDA will shut you down so fast, fine you, and make it a legal and regulatory nightmare to ever get off the ground again.
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Yeah, one does not simply ignore FDA (as many companies seem to have to learn the hard way)
 
sleepeeg3 said:
^this.

Why does a government agency get to decide whether I can receive information about my own genetics? That's BS. Those jerkoffs just want their tax money.
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I'm sorry, but you really just don't know what you are talking about.

They are the main reason why there are no longer people out there able to sell you snake oil (or even better, Radium!) off a cart, like in the bad old wild west days.

They can be a pain in my butt in my line of work, but I fully acknowledge that they are very important.

They primarily care about two things, safety and efficacy. Does the drug/device do what the manufacturer claims it does and does it do so without causing harm. If a company follows established methods for proving that these two are true, the rest is a formality.

I don't think any of us want a free-for-all healthcare market where anyone can claim anything, and release anything to market whether it works or not, or whether it is dangerous or not.

I don't think the FDA gives a rats ass about the genealogy and heritage portions of 23andme's results. What they are concerned with are the diagnosis aspects of it.

When they claim that they have found a gene that makes someone predisposed for a certain illness:

1.) Is their process actually reliable enough to not make errors and give false positives; and
2.) Do they have the statistical evidence (collected and documented properly) to prove that when they find that gene, it actually predisposes someone to the illness they say it does.

This would be to avoid harming patients, by having them spend time/money on seeking treatments for something that may or may not be real, and in some cases treatments can have some nasty and dangerous side effects, so you want to be really sure you are doing it for the right reason...
 
sfsuphysics said:
The commercials themselves have a disclaimer that this is for informational purposes only and isn't meant to replace medical advice.

I mean there's probably a lot more people using palm readers and other "psychics" for medical advice but there's no crack down on them.

As mentioned they use similar machines (the same?) as crime labs use, shouldn't the company they bought them from basically have the FDA approval which should carry over to them.
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Disclaimer doesn't matter. If it provides a diagnostic service it falls under their purview.

Otherwise everyone from drug makers to heart lung machine manufacturers would just slap a disclaimer on their products and be done.

For the genealogy portions of their service, this argument might hold water, but I'm sorry, people don't pay a hundred bucks to find out what diseases they might be predisposed to for the purposes of "fun". People are going to use it as a diagnostic service, disclaimer or not, and as such it has to be validated to be accurate.
 
Lame.

23andMe has been around for several years. Why now?

They've changed their test-kits as technology has progressed, and now it is a spiffy DNA microarray from Illumina. I've looked into using Illumina's equipment for research purposes... it's quite legit. But hell, from my perspective, the "DIY BIO" movement (a home Bio Lab = just a few thousand dollars and you can be "doing science" - heh) is great for scientific advancement...and I'm sure the FDA hates it.
 
Watching the Rooster Teeth podcast tonight I heard a little more about this case and why it is going on. The issue that the FDA has is the 23andMe claims to be a medical diagnostic process. Which kind of lends toward what Zarathustra[H] is talking about above.

That is why the FDA is involved. They have been trying since 2009 to get them to file the proper forms which they refuse to do. So they finally got tired of trying and just shut it down.

If they changed how the service was "sold" to people then there shouldn't be an issue. But since they claim this is a medical diagnostic process that they are offering you, they fall into the category of needing to be verified by the FDA to make sure that the diagnostic and results are valid.

That is why some weight loss meds chose their wording carefully so that they can get around any FDA checks.

So the choice of the classification of the service by the company is why the FDA is involved, not that they are just a pain in the ass per say.
 
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