As far as I can tell, none of the “health” results are about the patient’s health, only carrier status relevant to potential children. I imagine that is why the FDA is quicker to approve these tests than others, because there is not much the patient can do to act on it. (In theory the test could diagnose the same diseases, but I think they are all severe enough that the patient is expected to already know. Maybe they would be diagnostic for children.)
Except that they do predict lactose intolerance. That is in the “wellness” category, which I suspect are things that the FDA said it didn’t care about.
Although earlier users (like myself) still have access to their health reports, I suspect 23andMe isn’t putting the same effort into them since they could no longer market them and give them to new customers.
The author responds in comments:
I: There is a possible workaround. 23andMe will still supply you with your raw test results which you can then load into Promethease. To see what Promethease results look like click on over to SNPedia to view my frequently updated genetic testing report.
I use the Promethease report service. It’s probably better than what 23andMe is giving, though I expect in a free world 23andMe could do much better with all the genomes available and a customer base interested in sharing information and getting diagnosed.
Not yet, but 23andMe is still working on getting more tests approved. It’ll take some time, but at least they’re making progress, and the FDA isn’t totally shutting them out.
If the FDA took two years to make up standards for things that people have been doing without doctor involvement for decades, how long will it take for them to make up standards for 23andMe to be an over-the-counter competitor to Myriad? for 23andMe to do completely new things? a decade? five?
As far as I can tell, none of the “health” results are about the patient’s health, only carrier status relevant to potential children. I imagine that is why the FDA is quicker to approve these tests than others, because there is not much the patient can do to act on it. (In theory the test could diagnose the same diseases, but I think they are all severe enough that the patient is expected to already know. Maybe they would be diagnostic for children.)
Except that they do predict lactose intolerance. That is in the “wellness” category, which I suspect are things that the FDA said it didn’t care about.
That’s my understanding as well. New customers can’t get the old health reports despite this tiny opening:
https://reason.com/blog/2015/10/21/fda-takes-one-regulatory-shackle-off-23a
Although earlier users (like myself) still have access to their health reports, I suspect 23andMe isn’t putting the same effort into them since they could no longer market them and give them to new customers.
The author responds in comments:
I use the Promethease report service. It’s probably better than what 23andMe is giving, though I expect in a free world 23andMe could do much better with all the genomes available and a customer base interested in sharing information and getting diagnosed.
Not yet, but 23andMe is still working on getting more tests approved. It’ll take some time, but at least they’re making progress, and the FDA isn’t totally shutting them out.
If the FDA took two years to make up standards for things that people have been doing without doctor involvement for decades, how long will it take for them to make up standards for 23andMe to be an over-the-counter competitor to Myriad? for 23andMe to do completely new things? a decade? five?