Looks like no one has mentioned this already...
Even though 23andme isn't allowed to give health interpretations, other companies can take the raw data 23 provides and interpret it for you.
Specifically Promethease
They charge $5
It was this thread that inspired me to get my DNA sequenced, and I just got the results today, hence my posting in a year old thread.
Bakari--Thank you. I was sad to learn the FDA felt threatened by people knowing their medical info. I was looking for a company like the one you mention to get the health info. I appreciate your post.
The FDA wanted to know 23andMe's false positive and false negative numbers. THATS IT! 23andMe uses a cheap test that has fairly high (relatively) rates of inaccurate results. The other tests (the $3500 ones) are most likely way more accurate but we don't know because 23andMe is afraid to publish their accuracy rates.
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Promethease isn't any better in the FDA's eyes (or in mine) because they use the same physical tests. Both 23andMe and Promethease will say you have BCRA if their test gave you a false positive and that would be really bad for you! The FDA wants to protect people from things like getting voluntary mastectomies based on their 23andMe results only to later have an accredited test come back and say "oh yeah, you really don't have that variant. Too bad you got that preemptive mastectomy huh?"
That said, I love 23andMe, but if their results suggested something really bad, I'd pay for a real test and if my doctor recommended a real test, I wouldn't say "but 23andMe said I do/don't have that gene?!?!" I'd get the real test.
Promethease doesn't do ANY physical tests at all. All they do is take the raw data provided by 23andMe or ancestry.com (or anyone else) and run it through a database to interpert the data.
The accuracy of 23andMe's test is obviously not the only issue, because the FDA did not make them stop providing tests or the data from it, they just made them stop giving interpretations of health related data. You can still get all the same information from them (as the health info is there, just generic, and your raw data is there and searchable) but it is incredibly tedious to have to go through one by one.
In other words, if your interpretation of the situation was all there was to it, the changes the FDA insisted on hasn't fixed it.
The combination of DNA analysis and interpretation was what made them classify it as a "Medical Device", but as long as those two steps are done by separate companies - even though the same exact tests, with the same error rates are still being used - the FDA is fine with it.
Anyone who understands how genes work knows that having a particular gene (except for a very small set of conditions) only raises your probability of getting a disease, it doesn't make it inevitable. Hopefully that includes most doctors. Unless people start doing home masectomies or other DIY surgery, people have a chance to get reality checked on their results before they make a major decision like that.