- FDA Commissioner Scott Gottlieb said the agency is pursuing a new regulatory framework for diagnostics that could result in most tests being exempt from the premarket review process.
- In remarks prepared for a speech to the Friends of Cancer Research, Gottlieb said FDA should focus its premarket reviews on a subset of tests that are higher risk or highly novel, and many companion diagnostics and tests for home use.
- For other tests, FDA has proposed to Congress a precertification pathway that would allow the review for a single test to serve as the umbrella for clearing related tests, similar to what the agency has applied to direct-to-consumer genetic health risk tests, Gottlieb said.
The Diagnostic Accuracy and Innovation Act, introduced last year in the House, would allow FDA to regulate laboratory developed tests with a new category of in vitro clinical tests (IVCTs). A new FDA center would regulate test development and manufacturing, and CMS would oversee lab operations. Rep. Diana DeGette, D-Colo., and Rep. Larry Bucshon, R-Ind., are the bill’s sponsors.
The American Clinical Lab Association supports the bill but has questioned FDA’s ability to regulate the lab tests as medical devices, and contends that IVCTs should be regulated separately in a new center focused on diagnostics.
AdvaMed, which represents in vitro diagnostic test kit makers that are now subject to more rigorous FDA oversight, endorses a framework that would regulate all diagnostic tests in a consistent manner.
The FDA seems to agree.
"First, we should have a consistent approach for all in vitro clinical tests. Our approach needs to be the same whether the test developer is a traditional manufacturer or a clinical laboratory," Gottlieb said.
In laying out the agency’s agenda for the proposed diagnostics regulation, he said the approach would support the “extraordinary innovation” happening in the sector while also ensuring patients are protected. He predicted that fewer than 10% of all tests would require individual premarket review under the new framework. About 40% of tests would be eligible for a precertification pathway, and more than 50% would be exempt from premarket review.
About one-half of the test modifications that are currently subject to FDA premarket review would still be reviewed premarket. Reallocating FDA’s premarket review resources to higher risk tests would be accompanied by robust post-market review requirements to protect patients from potential risks, Gottlieb said.
"We know that many developers seek to continuously improve their tests. We shouldn’t stifle the natural iteration that characterizes the cycle of innovation in this space with overly burdensome pre-market review requirements," he said.
Most lab-developed tests on the market now would be grandfathered in under the new framework. In vitro clinical tests including manual tests, tests for rare disease, and low risk and low volume diagnostics, would also be exempt from premarket review.
FDA also would establish collaborative communities of scientists, clinicians, test developers and patients to help support the agency’s decision making.
“We could reduce patient screening time and the need for additional biopsies with more widespread use of these methods. And we could accelerate cancer drug development and improve clinical outcomes by pursuing these novel regulatory approaches,” Gottlieb said.