On March 1, Senators Gordon Smith and Edward Kennedy introduced to the Senate the Laboratory Test Improvement Act (S. 736) which will ask that direct-to-consumer DNA tests go through FDA assessment for accuracy and reliability. A public database is proposed that would contain information on FDA approval, laboratory certification, and whether the test has any clinical validity to diagnose or screen diseases or conditions and whether it can be used to make decisions about medical care.
Some of the concerns raised about at-home genetic testing:
More is UNknown about genes and their function than IS known. But I would counter that to say that for genes, such as BRCA for breast and ovarian, we know enough to predict a person’s risk fairly accurately. Is it fair to lump all genes together?
No one-on-one counseling is available for direct-to-consumer tests. This service varies between companies so if you’re uncomfortable not having access to a trained genetics professional, only purchase tests that give you a toll-free access number or email. Or if strict privacy isn’t a concern, you could always take the results to your private physician or genetics counselor and ask for help interpreting them. Keep in mind that not all physicians are trained in clinical genetics.
Medical privacy may be violated when results are posted online. A moot point when we’re moving towards electronic medical records (EMR) and so many of us purchase products online with credit cards.
No oversight. I have to agree that this one is a true concern. Almost anyone can create a genetic testing company as long as they have a laboratory that can perform the tests. This is why it’s important to do your research as well as keep in mind that if a company is doing a hard-sell for you to purchase supplements or other “accessories” for your health, there’s an ulterior motive to report your genome as having deleterious mutations.
As with all medical services, there are good apples and bad apples. And even though we’re calling all at-home DNA tests “apples,” there are actually many different varieties. Nutrigenomic testing and paternity testing cannot and should not be likened to disease or susceptibility testing.
Fortunately, because at-home DNA tests are still apples (meaning they all test for genetic variations), you can compare them relatively easily. If I were in the market, I would check the specific genes being analyed, the labs conducting the tests, privacy guarantees, the reputation of the people involved in the company, the resources available to the consumer for understanding their test results, price, and hidden hooks that try to get you to buy more products. Some of these answers will be easier to access if the bill passes and a public database is made available. But you may not need the info if the bill also clamps down on the sale of at-home consumer DNA tests.
In my opinion, consumers should be free to consume apple pies, as long as they get a choice of makers and realize that some apples pies taste better, and are better for you (no trans fats), than others. Guess I should quit with the apple analogy now….
KRT Wire, March 24, 2007