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The FDA put a stop to crowd-DNA research via the 23AM law suit. Prior to the lawsuit 23AM had a large user base completing questionnaires effectively mapping h
by billions 11y ago
The FDA put a stop to crowd-DNA research via the 23AM law suit. Prior to the lawsuit 23AM had a large user base completing questionnaires effectively mapping health risks, traits and allergies to genes. Not sure what the Food and Drug administration has to do with my genes other than regulatory overreach.
- dekhn 11y agoThis is not correct. They put a stop to 23&Me. There is still plenty of crowd-DNA research going on; for example, my genome and some medical information is online via GCG.
- toomuchtodo 11y agohttp://www.personalgenomes.org http://www.personalgenomes.org
- dekhn 11y agoSorry, I meant PGP not GCG (GCG was an old bioinformatics software).
- toomuchtodo 11y agoI too am a PGP participant!
- dekhn 11y agoI'm https://my.pgp-hms.org/profile/hu80855C https://my.pgp-hms.org/profile/hu80855C
- gavazzy 11y agoThey claimed it was a medical device in the same way as a glucose meter.
- refurb 11y agoIt has to do with the FDA protecting the public from crappy medical devices and drugs. IF you want to sell a genetic test, you need to prove to the FDA: (1) that your test is accurate and reproducible, (2) that whatever conclusion you draw from the test is scientifically sound. The issue was that 23&Me was saying "you have this SNP, that means your risk of X is increased by Y%". The test, the result and the conclusion is not based on a rigorous testing. Hell, some of the risk associated with SNPs is coincidental at best. That said, I'm fine if people want that info anyways, but 23&Me would need to add a disclaimer that says "Your genetic test results and the risks attributed to them may or may not be accurate."
- hueving 11y ago>It has to do with the FDA protecting the public from crappy medical devices and drugs. Which devices and drugs were 23&Me selling? I thought it was just crowd-sourced information about traits. Think how ridiculous it would be if the FDA just shut down a crowd-sourced database about trait correlations. But suddenly when a company like 23&Me correlates the two, it becomes pure, concentrated evil that must be subject to regulation.
- lfuller 11y ago23&Me was using a medical test to give users data regarding their risks of certain diseases without sufficiently proving to the FDA that that data was accurate. It's not a stretch to imagine someone acting on that information with potentially dangerous results; taking extra unneeded supplements, having elective surgery, dramatically changing their lifestyle to reduce the risk of some condition, etc.
- Karunamon 11y agoI'm so happy the FDA was there to prevent this company from doing the things with my genetic information that I asked them to do. Thank god for government.
- 11y ago