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The move could be a massive boon for the burgeoning industry.
FDA regulation has been a major barrier for the direct-to-consumer (DTC) genetic testing industry, but the agency today announced its commitment to changing that.
Acknowledging that DTC tests present “unique challenges to FDA regulation,” Commissioner Scott Gottlieb, MD, released a statement detailing steps that the regulator will take to streamline review.
Some tests will now be exempt from premarket review under certain conditions. “Exemption is limited to a genetic health risk assessment system that has received a first-time FDA marketing authorization … for the genetic health risk assessment system,” according to the official action. Although the FDA still requires an initial clearance, the move enables manufacturers of genetic health risk (GHR) tests to update their products without needing to reapply for approval.
The tests can deliver valuable personal risk information, but Gottlieb noted that inaccurate or incomplete information present dangers of their own. “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,” he posed.
To ensure the credibility of the DTC GHR test manufacturers, the agency’s new premarket review will include “special controls in a new de novo classification order” to outline requirements of accuracy, reliability, and clinical relevance.
A new final order will also allow genetic carrier screening tests from such review.
In his statement, Gottlieb compared the shifting approach to the firm-based pre-certification model that the FDA is now taking towards other digital health technologies. Like those technologies, the rapidity with which DTC GHR assessment capabilities evolve complicates the agency’s ability to evaluate them in a responsive manner.
The commissioner alluded to “important lessons” learned from its first approval of a DTC GHR test, granted to 23andMe earlier this year. That event ended a long, complicated stalemate between the Silicon Valley company and the regulating body. Now, the FDA’s decision to streamline such approvals could open the door for other companies to compete with the genetic testing giant, which currently distributes the only approved assessment of its type.
“We'll continue to look for opportunities to use this type of firm-based regulatory approach, both for new tests and other novel medical products,” Gottlieb said in the statement, placing today’s developments in the context of an overall effort to make the FDA more “nimble and creative” in its approach to new technologies.