The floodgates for direct-to-consumer genetic tests are swinging wide open.

The Food and Drug Administration plans on loosening many of the regulations surrounding genetic health risk tests, or GHRs, according to a statement Monday from Commissioner Scott Gottlieb. It’s a change of course for the agency, which in 2013 put a freeze on direct-to-consumer marketing of genetic tests for health conditions.

Since then, the FDA has generally been approving tests one by one before they hit the market.


The new proposed regulations will instead allow genetic carrier screening tests — those taken by prospective parents — and genetic health tests to enter the market without prior review.

Test manufacturers of these GHRs will just need a one-time FDA review to make sure they uphold the agency’s requirements — but after that, any subsequent GHR test they make won’t need further review.

The change may be an example of Gottlieb’s new credo to “deregulate by regulating.”

The new guidelines are similar to the “FDA Pre-Cert” model that FDA uses to regulate digital health products. That pilot program, unveiled in September, focuses on the software behind a digital health test as opposed to the individual products themselves. The idea is to vet a company’s underlying methodology rather than the products developed with it.

Regulating companies, not products

Genetic testing company 23andMe, which had been at the vanguard of genetic health tests, also suffered the biggest setback from the FDA’s stringent regulatory crackdown back in 2013. The FDA banned the company from marketing tests that predicted a customer’s likelihood to develop diseases like Alzheimer’s and Parkinson’s.

But this past April, the FDA changed its course on regulating 23andMe’s disease-predicting genetic tests — allowing the Silicon Valley company direct-to-consumer marketing rights that allow users insight into their risk for developing 10 different diseases. The move was expected to clear the way for more direct-to-consumer GHR tests — not just from 23andMe — to enter the market with minimal regulation.

Indeed, in April, the FDA announced that it planned on exempting further 23andMe tests from FDA premarket review — “and GHR tests from other makers may be exempt after submitting their first premarket notification.” This note from Gottlieb makes that guidance official.

Genetic health risk tests present “unique challenges to FDA regulation,” Gottlieb wrote in the statement, since they differ from how standard medical devices are evaluated solely for risk. Diagnostic and other such screening tests are generally considered a no man’s land of regulatory policy — with variable levels of federal enforcement from lab to lab. Gottlieb has indicated that he wants to tighten up regulations in the broader diagnostics space, making stronger distinctions between those that require stringent oversight, and those that can escape extra scrutiny.

Still, “while these tests can offer significant amounts of personal risk information, they’re not without their own risks,” the statement said. If GHRs “provide consumers with incorrect or misleading information,” that might influence their lifestyle or health care choices.

The agency will continue “firm based” evaluation of these types of products, Gottlieb wrote, working with manufacturers to continue developing regulations.

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