The safety risks of Direct-to-consumer (DTC) genetic tests available from retailers and the Internet, which let people learn about their genomes without going to a doctor are a cause for concern.
These test raise the question of who is responsible for oversight and regulation of these DTC tests.
AdvertisementEven critics worry about safety risks if consumers base important lifestyle or medical decisions on inaccurate or misunderstood test results.
A group of four leading bioethical, legal and medical researchers believes the solution will require an innovative approach that combines premarket studies done before tests enter the market with ongoing postmarket evaluations to confirm how well tests perform once they are in use.
Because DTC tests move in a global Internet marketplace, close international cooperation also will be required.
The team, led by Amy L. McGuire of the Center for Medical Ethics and Health Policy at Baylor College of Medicine in Houston, also include Barbara Evans of the University of Houston (UH) Law Center, Canadian legal expert Timothy Caulfield and Wylie Burke, M.D., of the University of Washington School of Medicine.
In their Science article, the authors note that more than 90 percent of the genetic tests now available in the United States have never been through a regulatory review to prove the tests are safe and actually improve human health.
A broad consensus exists for some form of regulatory review before new tests enter the market, but potential solutions have been mired in controversy.
There are practical barriers to forcing all new genetic tests to go through the same sort of data-intensive premarket review the Food and Drug Administration requires for other medical products, such as drugs.
"We favor a risk-stratified approach that tailors the regulatory requirements to the level of risk a DTC test actually presents," said Evans, who is also co-director of UH's Health Law and Policy Institute.
The group's policy recommendations for DTC genetic tests appear in the Oct. 8 issue of Science magazine, the world's leading journal of original scientific research, global news and commentary.