Home genetic testing kits are popular and generally safe for those who might want a glimpse into their ancestral background or other interesting oddities of their genome, but they can pose serious risks for those who rely on these often-unconfirmed and lightly regulated tests to make important medical or lifestyle decisions.
A team of leading legal, medical, and bioethical researchers, including Professor Barbara Evans of the Law Center, studied the issue and urge a risk-stratified approach that tailors regulatory requirements to the potential risks of each test. Their findings are published in the current issue of Science magazine.
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. They recommend that a combination of existing regulators and informal groups should pursue a hybrid approach that would continue to let most tests reach the market quickly, with relatively light pre-market review requirements. But regulators should have the power to keep a higher-risk test off the market until studies confirm it has an acceptable risk-benefit ratio. And, all tests should be subject to enhanced post-market follow-up to confirm that the test is safe and effective. Because the tests are sold via the Internet, close international cooperation would be required. “The public needs frank disclosure of what is not known about these tests,” Evans said.