Don’t Regulate DTC Genetic Testing
April 27th, 2011 | No Comments | Source: CommentaryToday, consumers can purchase dozens of medical tests without a prescription–tests that tell them whether they are pregnant, have a urinary infection, their cholesterol is too high, and so on.
Should direct-to-consumer (DTC) genetic tests be as readily available? These are the mail-in saliva tests that tell consumers about their genetic susceptibility to Alzheimer’s disease, type 2 diabetes, heart disease and other conditions.
DTC genetic tests are different from the genetic tests that have been used for decades in prenatal and newborn screening, and more recently in predictive testing (like the BRCA test for breast cancer risk).
The difference is not the substrate being tested. In both cases, it’s DNA. Rather, it’s who owns the testing process.
For the legacy DNA tests, health professionals own the process. As per protocol, they obtain permission (informed consent) from patients before ordering the test. Then, they consult with and support the patient once the results are known.
In contrast, DTC genetic tests transfer ownership of the genetic testing process to consumers. A person can decide for herself whether to get a DTC genetic test. She doesn’t need permission from a provider, and has no obligation to share the information with her provider.
This bothers many physicians, bioethicists and consumer advocates. They point out that DTC genetic test reports can be difficult to interpret (for physicians as well, I might add, despite claims that they are universally qualified to do so). They decry the lack of regulatory oversight of testing facilities which might help assure the accuracy and reliability of the information. Furthermore, reports of “egregious…deceptive marketing” by some DTC genetic testing vendors suggest that consumers maybe harmed, they say.
These people call for regulatory oversight of DTC genetic testing. The FDA has in certain limited instances, already begun to do just that.
Physician organizations tend to support the regulation of DTC genetic testing. In particular, they favor rules that transfer ownership of DTC genetic testing to (guess who?) physicians who can then serve as custodians of the information, just as they do for the traditional genetic tests mentioned above.
Set the Data Free
I disagree. People who want access to their genetic-risk information should be free to pay their own money to obtain it, period. The only place where regulation has a role in DTC genetic testing is to assure the quality of the results being generated. That’s it.



















