The U.S. Food and Drug Administration is taking steps to exempt select direct-to-consumer genetic testing manufacturers from premarket review, agency commissioner Scott Gottlieb, MD, wrote in a Nov. 6 statement.
Direct-to-consumer tests that evaluate an individual's genetic predisposition to various diseases may help encourage patients to make healthy lifestyle choices. However, these tests also pose a risk for consumers, since they have the potential to present a user with incorrect or misleading information.
"Consider the consequences of a person who is told they're not at risk for coronary heart disease and incorrectly opts to forgo dietary changes or drugs that reduce their risk of heart attack and death," Dr. Gottlieb wrote.
To regulate direct-to-consumer genetic tests, Dr. Gottlieb said the FDA has taken steps to implement a streamlined review pathway, similar to the pre-certification model the agency announced for digital health technologies in July.
Under the review pathway, genetic health risk testing manufacturers would approach the FDA for a one-time review to ensure they meet agency requirements, after which they would be able to deploy tests to the market without additional premarket review.
The goal of the premarket exemption is to provide "proper oversight in a flexible, new way," according to Dr. Gottlieb. "Our goal is to streamline the regulatory pathway to get innovative medical products to people more efficiently, while providing the FDA assurances that consumers seek," he wrote.
To access Dr. Gottlieb's statement, click here.