No the FDA is saying that they need to see proof that the test has a high level of accuracy and isn't just snake oil. 23andMe tried saying "you shouldn't actually use our test for diagnosing disease" to which the FDA said "then stop marketing it that way."
23andMe both wants to _say_ they have a totally accurate test, but doesn't want to pay to do the testing to prove it is totally accurate. The FDA is saying you can't have it both ways.
have you actually used 23andMe? All over the place, it says, the information is based on academic studies, these figures are only n star (on a rating from 1-5) reliable, it only is conclusive for ethnicities X, etc, etc, etc. Now, it is not clear to me that people read all that (in the aldehyde dehydrogenase test, a lot of caucasians don't realize that it only applies to asians, even though it says that in bold, font right underneath the title). There is no such thing as a totally accurate test and I don't think 23andMe says that anywhere.
I'm not sure total accuracy is the point. Rather, I think it's about the claimed value being correct. If 23andMe say a test has a 20% accuracy, they should be able to prove how they came by that number.
There's a big difference between telling someone they have a 5% chance of something and telling them they have a 25% chance of something - even though both are uncertain.
The issue isn't them saying "you have a higher likelyhood of disease." The problem the FDA has is 23andMe saying "you have the gene variation XYZ." If you take your 23andMe results to a doctor, the doctor should at best order a REAL FDA approved diagnostic test to see if you really do have variation XYZ because 23andMe hasn't proven that their test is accurate.
23andMe both wants to _say_ they have a totally accurate test, but doesn't want to pay to do the testing to prove it is totally accurate. The FDA is saying you can't have it both ways.