Skip to content

Regulatory Focus – FDA Looks to Build Diagnostics Framework Centered on Accuracy, Reliability and Safety

Regulatory Focus – FDA Looks to Build Diagnostics Framework Centered on Accuracy, Reliability and Safety

As Congress crafts new legislation on diagnostics to update a system first built in 1976, the US Food and Drug Administration (FDA) has offered feedback that will help to shape a modern framework whereby diagnostics can be relied on as accurate and safe, FDA Commissioner Scott Gottlieb said in a speech Thursday to the Friends of Cancer Research’s 7th Annual Blueprint for Breakthrough Forum.


Gottlieb noted that FDA envisions a world in which, “eventually, fewer than 10 percent of all tests would require individual premarket review. About 40 percent of tests would be eligible for a precertification pathway. And more than 50 percent of tests would be exempt from premarket review.”


The more flexible approach would also allow FDA to grandfather most laboratory-developed tests currently being offered to patients. And only about half of the diagnostic modifications currently subject to premarket review would still be reviewed premarket.


“Under this framework, all in vitro clinical tests would fall under a unified set of requirements that would also exempt from pre-market review many categories of new or subsequently-modified tests. This would include manual tests, tests for rare disease, and low-risk and low-volume diagnostics,” Gottlieb said.


The pre-certification pathway, meanwhile, builds on what FDA has done in the digital health space, whereby for those who qualify, “pre-certification would allow for review of a single test, and the validation procedures associated with that test, to serve as an umbrella for clearance of a suite of related tests.” This would allow FDA to focus its attention more on higher-risk and novel tests, as well as companion diagnostics and home-use tests.


But for the cancer space, FDA is envisioning a “compelling new paradigm” where “FDA would seek to establish collaborative communities of scientists, clinicians, test developers, and patients to help support the agency’s decision making.


“For example, FDA would hope to work on an on-going basis with leading oncologists, pathologists, and other outside experts in real time to develop standards for analytical validity for different types of tests. We’d also seek to work with the right experts to evaluate emerging clinical evidence to support the clinical validity of newly identified variants. Part of this approach would build off the steps we’ve taken for the regulation of next generation sequencing (NGS) tests,” he added.


“As clinical testing gets more and more sophisticated, we need to make certain that we have the right regulatory framework in place to ensure that these new clinical tests—including ones that we cannot even envision today—are accurate, reliable, and safe,” Gottlieb said.…