The FDA has left the matters up to individual states...in some states you need to have a physician involved....the web sites are portals set up to accommodate and provide the tests..called "Wild West" gene testing..."What's a diagnostic? What's not a diagnostic? And it's tricky."...but on the other hand you can go for a body scan if you want without a physician prescribing, although there will be a radiologist involved in the interpretation...and most of the sites recommend you do not share with your 
medical records to avoid misinterpretation from an insurance carrier...so who's genes are they? Enquiring minds want to know....BD
California health regulators are also investigating 12 complaints from the public about certain online gene testers. California won't name the targeted companies, but notes that in the state "all genetic tests must be ordered by a licensed physician." Overall, 24 states prohibit or limit so-called direct-access testing without a doctor or other medical professional's involvement, according to a 2007 survey by Johns Hopkins University's Genetics & Public Policy Center.
The clash highlights the fragmented regulatory environment for bespoke genotyping. The Food and Drug Administration has left it up to the states to decide what's permissible without a doctor's approval. "Basically everybody's trying to figure out what the regulatory environment is going to be for this consumer stuff," says Jay Flatley, Illumina's chief executive. "What's a diagnostic? What's not a diagnostic? And it's tricky."
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