Why is direct-to-consumer genetic testing an important issue right now?
A couple of things have come up in the genomics field in the last few years. One is that a bunch of studies have now allowed scientists to figure out which genes are associated with an increased risk of getting certain diseases later in life. And another advance is that these test have gotten a lot cheaper than they used to be. They used to be really research tools. Now they're becoming much more practical on a day to day basis. So you put this together and it opens up the possibility of people sending in a blood sample, or even just a spit sample, which is how this is often done, and finding out from genetic analysis of those samples which diseases you are most likely to get later in life. The good news here is that is opens up the possibility of a whole future of personalized, predictive medicine where people can find out what they're at risk for and maybe take some preventive measures, or make lifestyle changes so they can lower their chances of getting those diseases. On the other hand, this is tricky information to interpret, and it opens up a whole new arena of web-based risks where people have to really understand what they're getting into.
Why have come states clamped down on new companies offering personalized genetic testing?
As it turns out, the federal government hasn't really kicked in on regulating genetic tests much yet, and in particular the Food and Drug Administration has not decided yet how it's going to regulate most gene tests. So states have kicked in first, and in fact, the states of California and New York have already sent warning letters to several of these gene test companies saying that these states believe these companies may be out of compliance with states laws. State laws vary from state to state, but most of them require that a doctor order these tests, and that makes it difficult for consumers to order them themselves on the web, which is how most of these companies work.
What policies can ensure that consumers benefit from safe and accurate genetic testing?
Several of these gene test companies themselves have decided to get together and put together a package of best practices that they claim will ensure that they do a good job, and that consumers will be protected. In fact, that's really not going to be enough. I think experience shows that when there's a lot of profit to be made, especially in the medical sector, it's nice to have some outside regulation. I think what really needs to happen here is the Food and Drug Administration needs to step up to the plate, and if not regulate genetic testing in a hard and fast way, at least set out some clear guidances that tell companies what the boundaries of acceptability are going to be in this business. And the Federal Trade Commission needs to step up to the plate and start enforcing its rules and perhaps take a few of these companies to court that are the most blatantly engaged in false advertising or snake oil sales.