Currently, laboratory-developed tests — the basis for 70 percent of medical decisions made in the U.S. — don't require FDA clearance. That could change in the next several years if a proposed rule to phase in more regulation of lab tests is finalized.
The FDA issued a proposed rule Sept. 29 to strengthen its oversight of the lab tests and treat them as medical devices. Laboratory-developed tests, or LDTs are those designed, manufactured and used within a single clinical laboratory, and often used in hospital and academic medical center labs.
"A growing number of clinical diagnostic tests are being offered as laboratory developed tests without assurance that they work," FDA Commissioner Robert Califf, MD, said in a news release about the proposed rule. "The stakes are getting higher as these tests are increasingly being used to drive treatment decisions."
The proposed rule cited evidence that demonstrates the tests, when inaccurate, can lead to patients initiating unnecessary treatment, delaying or forgoing treatment altogether, among other issues. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health told CNN that the rule would require manufacturers to register tests with the agency, and the FDA would then review lab tests based on the risk to patients.
In reacting to the proposal, some experts told The Washington Post the proposal addresses one of the most significant regulatory gaps remaining at the FDA, while critics, such as those representing academic medical centers, argue such regulation could stifle innovation.