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Today, 23andMe was granted authorization by the U.S. Food and Drug Administration (FDA) to offer the Bloom syndrome carrier status report. This is an important first step in fulfilling our commitment to return genetic health reports to consumers.
This is the first time the FDA has granted authorization to offer a direct-to-consumer genetic test, and it gives us a regulatory framework for future submissions. While this authorization is for a single carrier status test only, we are committed to returning health information to our US customers who don't already have this information once more tests have been through this process and we have a more comprehensive product offering.
The FDA has been incredibly responsive throughout our review and has demonstrated its support for direct-to-consumer genetic testing. We will continue to work with the agency to ensure that all future health submissions meet FDA standards.
It's been a challenging and exciting time for consumer genetics. Your support and stories sent along the way make my job worthwhile. I will continue to provide you with updates on our blog and by email.
Thank you so much for your ongoing support during this process.
I just thought I'd post this for those of us who been tested with 23andME and have been disappointed that they lost their ability to provide health results along with the DNA testing. It's good to know that they have been working to get it back and the results so far sound encouraging. Many people here will have a better understanding than I do so feel free to expound.
I just thought I'd post this for those of us who been tested with 23andME and have been disappointed that they lost their ability to provide health results along with the DNA testing. It's good to know that they have been working to get it back and the results so far sound encouraging. Many people here will have a better understanding than I do so feel free to expound.
23andme has continued to provide some health related info with their DNA results. The FDA prohibited them from advertising or marketing their tests as providing medical information or genetic testing. They may have also reduced the info provided. Apparently they may soon begin be allowed to do so again and will likely expand on the info currently available.
23andme has continued to provide some health related info with their DNA results. The FDA prohibited them from advertising or marketing their tests as providing medical information or genetic testing. They may have also reduced the info provided. Apparently they may soon begin be allowed to do so again and will likely expand on the info currently available.
When I had my DNA tested a little over a year ago, I received a long list of possible health conditions and information regarding whether or not I was likely to be affected. The FDA ordered them to stop handing that information out. I don't know how much information anyone receives now, I just know that mine contained a lot and that now, people receive very little or nothing at all.
The intent was to create a huge data base with enough results to make it valid in the field of medicine. It seems that this would have been a great help to medical science and those of us who had contributed were disappointed when it had to end.
23andME was supposed to provide more documentation to the FDA in hopes that they would, once again, be allowed to provide health data.
I did test in 2011 and got my health info. When I heard about the FDA thing, I printscreened every sibgle page of the health part, but with time I noticed it was a waste to do that because they simply stopped providing that info to new customers. Everyone else maintained their health info and was even periodically updated.
My doctor definitely appreciated the health info my test shows, so 23andme is not supplying BS to people. I think the US government sometimes goes over board with its regulation.
Is the health information based 100% on their genetic testing, or do reports that family members write into their information get figured in?
For example: 1 family member had the test done with health included. In his report throat cancer was listed as a high risk factor. The parent of this person, did indeed succumb to this throat cancer.
I was unaware that genetic testing was possible for throat cancer. Did 23 and Me see an actual genetic marker for it in my relative, or was the risk heightened and included in his health report because he manually reported that his parent developed this cancer?
Also, I don't understand why 23 and Me is being blocked by the FDA, when you can take your raw data from 23 and Me and submit it to outside sites that will generate the same health reports for you?
I got my DNA results in January but no health information at all.
My husband and I got in right under the wire - literally a week or so before they were banned from providing the information. It was very interesting, and I hope they can gain back the right to share that information with customers in the future.
Is the health information based 100% on their genetic testing, or do reports that family members write into their information get figured in?
For example: 1 family member had the test done with health included. In his report throat cancer was listed as a high risk factor. The parent of this person, did indeed succumb to this throat cancer.
I was unaware that genetic testing was possible for throat cancer. Did 23 and Me see an actual genetic marker for it in my relative, or was the risk heightened and included in his health report because he manually reported that his parent developed this cancer?
I don't know. All I can tell you is that 23andme put me at a heightened risk of bladder cancer - and my father has bladder cancer, which I did not share with 23andme. I am also at a heightened risk for restless leg syndrome and I know there weren't even any questions about that on any questionnaires that I can recall.
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