FDA To Remove Barriers for 23andMe-Type Genetic Test Developers

Companies looking to launch direct-to-consumer (DTC) genetic tests could have fewer regulatory hoops to jump through in the future if the FDA’s proposed review process is finalized. Last week, the regulator announced that manufacturers of these genetic health risk (GHR) tests will only be required to undergo one review by the agency, after which they’ll be permitted to market new tests without further regulatory oversight.

“The accelerated development of these innovative DTC genetic risk tests paired with the known safety considerations presents unique challenges to FDA regulation, as these technologies don’t fit squarely into our traditional risk-based approach to device regulation,” said FDA Commissioner Scott Gottlieb in a statement about the review pathway. “In its consideration of GHR tests, the FDA seeks to strike a balance that provides for an efficient pathway to bring these tests to consumers, without sacrificing the assurances offered by FDA oversight.”

In his statement, Gottlieb points out both the benefits and potential risks of GHR tests. While individuals who learn that they carry a genetic risk factor for certain diseases – such as breast cancer or dementia – may make lifestyle changes aimed at reducing their risk, the fact that the information is provided without guidance from a medical professional could prompt people to make uninformed choices.

23andMe, the leader in the GHR test market, has had a turbulent history with the FDA. While the personal genetics company has been selling its tests to consumers for nearly 10 years, they only just received the FDA’s go-ahead to start informing consumers about their risk of developing 10 different diseases in April of this year.

The new regulatory approach couldn’t be more different from the way the FDA oversees the marketing of new drugs and medical devices. The pathway is similar to the FDA’s precertification pilot program (FDA Pre-Cert) for digital health technologies, which focuses on evaluating the product developer as opposed to each individual product on its own.

“Consumers are increasingly embracing genetic health risk (GHR) testing to better understand their individual risk for developing diseases,” said Gottlieb. “We’ve committed on several fronts to take a fresh look at how we regulate truly novel medical advances to ensure that the FDA is encouraging their development and creating pathways that are risk-based, efficient, achieve the assurance of safety and efficacy, and in the case of tests, analytical and clinical validity, through a framework that is least burdensome.”