A Food and Drug Administration advisory panel, taking aim at genetic tests sold directly to consumers, has recommended that such evaluations be permitted only under the supervision of a doctor.
As the Los Angeles Times reports, the FDA panel took its position in response to the online marketing of the tests as well as concerns about their lack of reliability. The panel’s decision was disclosed Tuesday, on the first day of two days of hearings on the tests.
“I would suggest that we are not ready yet to put this completely in the consumer’s hands,” said Joann Boughman, a panelist who represents the American Society of Human Genetics. “Each test is complex, and when you have each provider doing slightly different tests, it complicates it even more.”
One example mentioned by the panelists was a test for cystic fibrosis. Because some consumer tests might fail to track all of the possible causes of the disease, false negatives could result — in other words, some consumers might be led to believe that they aren’t at risk when, in fact, they are.
The genetic tests typically are purchased from online vendors. Walgreen Co. had announced in May a plan to stock a brand of genetic tests, but the drugstore chain later backed away from the plan because of the uncertain regulatory climate.
The FDA panel consists of 21 physicians and academics. Although the panelists did not outline a specific proposal, they indicated that the ordering and interpretation of genetic tests should be under a doctor’s control.
Advisory panels’ recommendations don’t automatically determine FDA positions, but the agency generally follows the advice.
Official doubts about the benefits of genetic tests were raised by a July report from the Government Accountability Office. It found that tests from four companies on a single DNA sample came to three different conclusions regarding the risks of prostate cancer and hypertension.
