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- Sep 15, 2013
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FDA "meddling"...sparklemilhouse said:Apparently you can only use the service now for ancestry reasons, due to the FDA meddling.
On November 22, 2013, after not hearing from 23andMe for six months, the FDA ordered 23andMe to stop marketing its Saliva Collection Kit and Personal Genome Service (PGS) as 23andMe had not demonstrated that they have "analytically or clinically validated the PGS for its intended uses" and the "FDA is concerned about the public health consequences of inaccurate results from the PGS device".
The FDA’s account seems to show the agency giving 23andMe a lot of chances, and to show a willingness to find a way to work with the startup. The FDA references 14 face-to-face meetings and telephone calls, hundreds of emails and dozens of written communications during which the agency said it provided specific feedback on study protocols that would prove 23andMe’s tests were useful as diagnostics and other tests to prove the 23andMe kits gave consistent results. Instead, 23andMe expanded how its test was used. In January, the FDA says the company promised that it was doing extensive studies that would take months to complete – and then that promised data never materialized. This is not the way to deal with a powerful government regulator.
23andMe’s statement on the news? “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.”
1. This proposed class action alleges that 23andMe, Inc. (“Defendant”) falsely and misleadingly advertises their Saliva Collection Kit/Personal Genome Service (“PGS”) as providing “health reports on 240+ conditions and traits”, “drug response”, “carrier status”, among other things, when there is no analytical or clinical validation for the PGS for its advertised uses.
2. In addition, Defendant uses the information it collects from the DNA tests consumers pay to take to generate databases and statistical information that it then markets to other sources and the scientific community in general, even though the test results are meaningless.
hellbound said:Also, even though the FDA shut down their genetic health information for the time being, you can still access your genome and, say, load it into SNPTips or the like and get much of the same information. For now.
hellbound said:I'm told you should have access to the raw data no matter what, and you should be able to find a service that will show you. I can ask my mother for how to do it because she did load hers into SNPtips, but it's not easy to use.
Surtur said:Mine is on its way back, does anyone know how long it takes before you see results?
If I had my DNA tested and found out that I have even the smallest trace of Hulkamania I would probably jump off a building knowing that I carry loser DNA. But no worries, the Hulkamanian gene will be erased from the human genome by the Outsiders at Bash at the Fanfic. 8-)
Only 3.0%, Trolled by that danf MourningDove.