It has to do with the FDA protecting the public from crappy medical devices and drugs.
IF you want to sell a genetic test, you need to prove to the FDA: (1) that your test is accurate and reproducible, (2) that whatever conclusion you draw from the test is scientifically sound.
The issue was that 23&Me was saying "you have this SNP, that means your risk of X is increased by Y%". The test, the result and the conclusion is not based on a rigorous testing. Hell, some of the risk associated with SNPs is coincidental at best.
That said, I'm fine if people want that info anyways, but 23&Me would need to add a disclaimer that says "Your genetic test results and the risks attributed to them may or may not be accurate."
IF you want to sell a genetic test, you need to prove to the FDA: (1) that your test is accurate and reproducible, (2) that whatever conclusion you draw from the test is scientifically sound.
The issue was that 23&Me was saying "you have this SNP, that means your risk of X is increased by Y%". The test, the result and the conclusion is not based on a rigorous testing. Hell, some of the risk associated with SNPs is coincidental at best.
That said, I'm fine if people want that info anyways, but 23&Me would need to add a disclaimer that says "Your genetic test results and the risks attributed to them may or may not be accurate."