Companies that sell complicated genetic tests directly to consumers may be putting people at risk, a top US health official has announced.
Without a doctor’s guidance, consumers might choose to stop taking heart medications or skip routine breast cancer screening based on the results of tests that might not be accurate, said Dr Jeffrey Shuren, head of the US Food and Drug Administration’s devices division.
Since 1976, the FDA has chosen not to regulate simple diagnostic tests developed in individual laboratories, but an explosion of complicated tests, often for common but deadly diseases, has forced the FDA to revise that policy, Shuren said in a telephone interview.
“We’re not opposed to marketing directly to consumers. We just think consumers should be getting accurate, reliable results,” Shuren said.
Shuren said lab-developed tests are no longer simple tests for rare diseases done in individual labs. In some cases, these unregulated tests are being used instead of FDA-approved tests, and they are being developed by corporations instead of pathologists or public health labs.
With direct-to-consumer tests, sold by companies like 23andMe Inc, Navigenics Inc and Pathway Genomics Corp, Shuren said he was concerned that patients would not know how to act on the results, or might be falsely assured that their genetic risk of a disease was low. Google Inc is an investor in 23andMe.
Direct-to-consumer tests drew headlines in April when Walgreen Co said it would begin offering genetic test kits made by privately held Pathway Genomics. Walgreen put its plans on hold when the FDA raised concerns. Shuren said Pathway has stopped marketing its tests to consumers.
At the meeting, David Becker of Pathway said requiring companies to enroll their tests in the government’s genetic testing registry and requiring that the labs be accredited should offer enough protection for consumers.
But Alan Mertz of the American Clinical Laboratory Association, who testified at the meeting, said such tests should be ordered by doctors, who are familiar with their limitations.
“If a doctor orders a test, the doctor will know you were a good candidate, and they can help you interpret the results.”