It has to do with the FDA protecting the public from crappy medical devices and drugs.<p>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.<p>The issue was that 23&amp;Me was saying &quot;you have this SNP, that means your risk of X is increased by Y%&quot;.  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.<p>That said, I&#x27;m fine if people want that info anyways, but 23&amp;Me would need to add a disclaimer that says &quot;Your genetic test results and the risks attributed to them may or may not be accurate.&quot;