After FDA order, 23andMe halts health-related genetic reports
16 replies, posted
[URL]http://blog.23andme.com/news/23andme-provides-an-update-regarding-fdas-review/#respond[/URL] 23andMe's own response
[URL]http://www.nbcnews.com/science/after-fda-order-23andme-halts-health-related-genetic-reports-2D11708452[/URL]
[QUOTE]MOUNTAIN VIEW, Calif. — Genetic testing company 23andMe Inc. will comply with a Food and Drug Administration directive to stop providing access to health-related reports from its tests during a regulatory review. The Mountain View, Calif., company said late Thursday that it will continue to provide ancestry-related information to customers and raw genetic data without interpretation. Those customers could receive additional, health-related information in the future, depending on whether the FDA grants marketing authorization.
Customers who bought kits since the FDA order came out late last month also will be eligible for refunds.
FDA representatives did not immediately return a phone call from The Associated Press seeking comment on the company's announcement.
23andMe claimed that its test kit, launched more than five years ago, could tell customers about their risk for more than 250 diseases and health conditions. The company sells its tests online. Customers receive a small tube in the mail, which they return to the company with a saliva sample for DNA analysis.
The FDA says only medical tests that have been cleared by the government are permitted to make such claims.
Last month, the agency had ordered 23andMe to stop marketing its test, warning that erroneous results could cause customers to seek unnecessary or ineffective medical care. The FDA warning letter stated that even after numerous meetings and email exchanges with the company, the agency still had no assurance that the firm has analytically or clinically validated its technology. [/QUOTE]
Pretty sad news. Me and Starpluck did this test a while ago and aren't affected by it. However anyone that got it after November the 22nd won't receive health information. I guess there is some point behind FDA's order... But I don't see why there's a need to completely bar it.
Now 23andMe only offer ancestry information, which of course is fun, but just a small part of the results.
Yikes, that's kinda terrible.
I was actually considering doing this, just to see what would come up. Kinda blows that its no longer available.
Sounds like the company was bullshitting.
Well, they have a point in shutting them down. Saliva testing gives false positives, i.e. you get an HIV test and it comes up positive, but then you have blood drawn and it shows up negative.
[QUOTE=Falubii;43101205]Sounds like the company was bullshitting.[/QUOTE]
Not necessarily. The results are not confirmed whether to be right or wrong.
[QUOTE=Falubii;43101205]Sounds like the company was bullshitting.[/QUOTE]
[QUOTE=Squad1993;43101229]Well, they have a point in shutting them down. Saliva testing gives false positives, i.e. you get an HIV test and it comes up positive, but then you have blood drawn and it shows up negative.[/QUOTE]
Yeah but this isn't the same. But this doesn't show you anything like that.
You spit in a tube. They take the spit and run it through a DNA sequencer. And they use the data from the sequencer + data from various studies to give you the results.
My traits and ancestry results are spot on. Down to the exact colors of my eyes and my type of hair.
Regarding health things:
[IMG]http://i.imgur.com/hCQpJvR.png[/IMG]
and when you open one of them you get, each tab is filled to the brim with details. Each backed up with studies.
[IMG]http://i.imgur.com/CRr6Jhn.png[/IMG]
Of course these can't be used to claim that you actually suffer from a disease, or even be used for any medical situation. I think it's just a fun thing and see no reason why it should be barred.
[QUOTE=Falubii;43101205]Sounds like the company was bullshitting.[/QUOTE]
Not really, they base it off of good probabilities which is based on your genetic markers. Federal protocol mandates that information that assesses your health and genetics to the degree done by 23andme must go through rigorous government-standards before they can consider it valid.
The information is accurate, they just aren't in compliance with federal guidelines. You have to be retarded to think Microsoft and Google would back an organization that is straight-up bullshitting.
I don't understand the ban, they don't claim you are sick as far as I know, only what your risk is according to their analysis.
[QUOTE=Swebonny;43101587]Yeah but this isn't the same. But this doesn't show you anything like that.
You spit in a tube. They take the spit and run it through a DNA sequencer. And they use the data from the sequencer + data from various studies to give you the results.
My traits and ancestry results are spot on. Down to the exact colors of my eyes and my type of hair.
[/QUOTE]
Ahh ok. So kinda like your risk for getting a disease based on your family history kind of thing? I thought it was like "YOU HAVE THESE DISEASES" like webmd bs.
But still, it may not be entirely accurate because it's saliva. Blood tests are only sure fire way. For example what if you kiss someone then take the test? Wouldn't be very accurate. That's an extreme case but I feel like something simple like that would throw off the results.
and IMO, I wouldn't spit in a tube and mail it to some company to be tested when I can just go to the clinic or hospital.
They were claiming to be an accurate way to test for diseases iirc
[QUOTE=Squad1993;43101663]Ahh ok. So kinda like your risk for getting a disease based on your family history kind of thing? I thought it was like "YOU HAVE THESE DISEASES" like webmd bs.
But still, it may not be entirely accurate because it's saliva. Blood tests are only sure fire way. For example what if you kiss someone then take the test? Wouldn't be very accurate. That's an extreme case but I feel like something simple like that would throw off the results.
and IMO, I wouldn't spit in a tube and mail it to some company to be tested when I can just go to the clinic or hospital.[/QUOTE]
Yeah exactly, it's just risks.
It's just using the cells you have in the saliva. Exchanging loads of saliva with someone just before the test may alter the results yeah :v: But I think they're pretty thorough during their testing process, I got denied at first because my saliva wasn't "good enough" so I had to order a new kit (for free).
The raw data gets as accurate as these machines allows: [url]http://en.wikipedia.org/wiki/DNA_sequencer[/url]
I did it just for the ancestry thing. The health risks and stuff were a great bonus for me.
Here how the raw data looks like btw:
[IMG]http://i.imgur.com/XQABEpE.png[/IMG]
[QUOTE=Swebonny;43101751]Yeah exactly, it's just risks.
It's just using the cells you have in the saliva. Exchanging loads of saliva with someone just before the test may alter the results yeah :v: But I think they're pretty thorough during their testing process, I got denied at first because my saliva wasn't "good enough" so I had to order a new kit (for free).
The raw data gets as accurate as these machines allows: [url]http://en.wikipedia.org/wiki/DNA_sequencer[/url]
I did it just for the ancestry thing. The health risks and stuff were a great bonus for me.
[/IMG][/QUOTE]
Wow actually that seems pretty cool just to try. I can understand shutting them down because some people may read the results as if they actually have those diseases. Kinda lame they got shot down basically on a technicality.
wow I want to do one now.
[QUOTE=Swebonny;43101751]Yeah exactly, it's just risks.
It's just using the cells you have in the saliva. Exchanging loads of saliva with someone just before the test may alter the results yeah :v: But I think they're pretty thorough during their testing process, I got denied at first because my saliva wasn't "good enough" so I had to order a new kit (for free).
The raw data gets as accurate as these machines allows: [url]http://en.wikipedia.org/wiki/DNA_sequencer[/url]
I did it just for the ancestry thing. The health risks and stuff were a great bonus for me.
Here how the raw data looks like btw:
[IMG]http://i.imgur.com/XQABEpE.png[/IMG][/QUOTE]
That's neat. I wonder what the false positive rate is. In other news, using that picture I shall make a clone of you.
[editline]7th December 2013[/editline]
Ok good they still exist but they don't give you their interpretation which is reasonable I feel. Their interpretation is rather likely to be untrue so wee!
In science we actually watched a documentary on this, and in it they said that if it got in the hands of insurance providers they could abuse it and not give it to certain people that are more likely to get a certain disease or something.
[QUOTE=Blockhead;43103406]In science we actually watched a documentary on this, and in it they said that if it got in the hands of insurance providers they could abuse it and not give it to certain people that are more likely to get a certain disease or something.[/QUOTE]
That already happens to a degree. How many people in your family had diabetes, strokes, heart attacks, cancer, etc.
Something fascinating is going to be how this develops in the political spectrum. At some point in the future a politician will release their genome, and proudly proclaim they are perfect for the job because they aren't likely to do *insert something bad here*. It's going to be interesting/terrifying to see how that unfolds.
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