Why does the FDA prevent the sale of health reports that may affect a diagnosis or treatment plan to consumers?

Question

So I was reading an interesting article from MSN how a company can now map your genome for a relatively small fee. It mentions something confusing, that being that

[...] the FDA restricts direct sales of health reports to consumers that have the potential to diagnose or change a course of treatment — information considered actionable [...]

Why would the FDA limit actionable material that may enhance treatment? I'm certain it's probably inbetween the lines of the linked article, but I don't understand why such information would not be made available to consumers.

Answer 1

Why would the FDA limit actionable material that may enhance treatment?

Because the FDA has a bunch of regulations that say if you are going to sell a medical test you first have to prove that it is safe, accurate, and effective. The genome scan companies first had to prove that their genome scans were accurate and had sufficient quality controls built in.

In addition, the typical results from a genome scan involve a lot of ambiguity, and probabilistic measurements of relative risk, so there was a huge question of whether the automated reports produced by these companies would actually be accurate, intelligible, and not promise too much or too little to the consumer. The company, Sure Genomics, in the article you linked too, apparently avoids this issue by having a physician review the report, and consult with the consumer. Other companies tried to completely automate the process and didn't include the physician consultation.

As least one company, 23andMe, has, at least partially, worked out it's issues with the FDA and can provide medical reports on some conditions.