23andMe meets FDA standards, adds back wellness reports
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23andMe meets FDA standards, adds back wellness reports
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Re: 23andMe meets FDA standards, adds back wellness reports
#2I would like to know how the new report compares to the old one.
Also of note, the price has gone up from $99 (as of earlier this week) to $199.
edit: This NYTimes article has more details: http://www.nytimes.com/2015/10/21/business/23andme-will-resu...
Now, after nearly two years, 23andMe is announcing on Wednesday that it will begin providing customers with health information again, though much less than before and with F.D.A. approval.
The new health-related information 23andMe will provide is called carrier status. That relates to whether people have genetic mutations that could lead to a disease in their offspring, presuming the other parent has a mutation in the same gene and the child inherits both mutated genes. There will be information on 36 diseases, including cystic fibrosis, sickle cell anemia and Tay-Sachs.
Re: 23andMe meets FDA standards, adds back wellness reports
#3I would like to know how the new report compares to the old one. Also of note, the price has gone up from $99 (as of earlier this week) to $199. edit: This NYTimes article has more details: http://www.nytimes.com/2015/10/21/business/23andme-will-resu... Now, after nearly two years, 23andMe is announcing on Wednesday that it will begin providing customers with health information again, though much less than before and…
I don't know anything about this particular filing, but the FDA is primarily concerned with you having demonstrated safety and efficacy.
For this reason, I would suspect the new reports will not include anything that they could not provide scientific evidence for effective differentiation, as well as anything without convincing argument that a report would not increase workup rates, etc. with some inherent risk.
Re: 23andMe meets FDA standards, adds back wellness reports
#4I would like to know how the new report compares to the old one. Also of note, the price has gone up from $99 (as of earlier this week) to $199. edit: This NYTimes article has more details: http://www.nytimes.com/2015/10/21/business/23andme-will-resu... Now, after nearly two years, 23andMe is announcing on Wednesday that it will begin providing customers with health information again, though much less than before and…
I don't know anything about this particular filing, but the FDA is primarily concerned with you having demonstrated safety and efficacy. For this reason, I would suspect the new reports will not include anything that they could not provide scientific evidence for effective differentiation, as well as anything without convincing argument that a report would not increase workup rates, etc. with some inherent risk.
I just like knowing I have the trait for smelling asparagus in urine.
Re: 23andMe meets FDA standards, adds back wellness reports
#5I hope this means we can finally upgrade our results to the latest chip, or that they restore some of the SNPs they dropped in the later chips that make these reports impossible to compute.
I've been waiting to unlock the Alzheimer's results for ages, but it always tells me that "upgrading to the latest platform is unavailable".
Re: 23andMe meets FDA standards, adds back wellness reports
#6I hope this means we can finally upgrade our results to the latest chip, or that they restore some of the SNPs they dropped in the later chips that make these reports impossible to compute. I've been waiting to unlock the Alzheimer's results for ages, but it always tells me that "upgrading to the latest platform is unavailable".
I could be wrong, but I think you can still export your raw genetic data, right? If so, have you checked out Promethease? I have not used it in a while, but I imagine it will tell you most if not all of what 23andMe would have on Alzheimer's (and quite possibly more).
http://www.snpedia.com/index.php/Promethease https://promethease.com/
Re: 23andMe meets FDA standards, adds back wellness reports
#7Please someone in another country provide the data 23 and me used to provide!!!
Re: 23andMe meets FDA standards, adds back wellness reports
#8Earlier quoted context omitted.
I don't know anything about this particular filing, but the FDA is primarily concerned with you having demonstrated safety and efficacy. For this reason, I would suspect the new reports will not include anything that they could not provide scientific evidence for effective differentiation, as well as anything without convincing argument that a report would not increase workup rates, etc. with some inherent risk.
I just like knowing I have the trait for smelling asparagus in urine.
This doesn't seem like something you'd need a genetic test to determine.
Re: 23andMe meets FDA standards, adds back wellness reports
#9Earlier quoted context omitted.
I don't know anything about this particular filing, but the FDA is primarily concerned with you having demonstrated safety and efficacy. For this reason, I would suspect the new reports will not include anything that they could not provide scientific evidence for effective differentiation, as well as anything without convincing argument that a report would not increase workup rates, etc. with some inherent risk.
I just like knowing I have the trait for smelling asparagus in urine.
Hahah agreed with @kej. Jokes aside, I've held off getting 23andMe because of this reason. Does anyone know?
Re: 23andMe meets FDA standards, adds back wellness reports
#10also, I don't trust them with my DNA data anymore.