23andMe

For a long while, the Food and Drug Administration (FDA) has not supported the idea of consumer DNA tests. However, in a recent statement from FDA Commissioner Scott Gottlieb, has hinted that the agency could soon be loosening their regulations associated with genetic health risk tests. 

He said, “Consumers are increasingly embracing genetic health (GHR) testing to better understand their individual risk for developing diseases. This engagement prompts some people to make more informed lifestyle choices.”

According to Gizmodo, the new regulations would enable genetic health tests on the market, without having a prior review. Instead of the normal routine, companies wanting to sell a test would come to the FDA for a one-time review.

“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,” added Gottlieb. 

If the regulations are accepted, they would be an expansion of the deal the agency offered genetic testing company 23andMe earlier this year. After initially slamming the company’s proposal of assessments for more than 250 diseases and conditions, it eventually gave them the green light to market tests for 10 diseases or conditions directly to consumers, as well as announced that future 23andMe tests would be exempt from premarket review by the agency. 

 Gottlieb explained that consumer genetic tests don’t “fit squarely” into the agency’s “traditional risk-based approach to device regulation.”

“While these tests can offer significant amounts of personal risk information, they’re not without their own risks, especially if they provide consumers with incorrect or misleading information that may be used to make health choices without considering the advice of a medical professional.”

He continued to state that the goals of the new rules are similar to that of the “FDA Pre-Cert” program pilot that FDA unveiled in September to regulate digital health products. Instead of vetting each individual product before it hits the marketplace, the agency wants to assess the validity of  company’s methodologies and practices. 

This news may well be a hint that the agency is planning to place more scrutiny on a consumer genetic testing market, in which case experts have raised concerns about accuracy, reliability and privacy.