NEW YORK – The US Food and Drug Administration announced on Tuesday that it has launched a voluntary pilot program intended to reduce the risks of laboratory-developed tests used to select patients for oncology therapies.
Currently, the FDA allows approvals of drugs without authorized in vitro companion diagnostic tests in certain limited circumstances. Instead, laboratory-developed tests that haven't received the FDA's OK are used for patient treatment decisions. However, the agency said in a statement that it has "become increasingly concerned" that some of those LDTs may not perform as well as FDA-authorized tests.
Under the pilot program, the agency will ask pharmaceutical manufacturers to provide performance information for tests used to enroll patients in clinical trials supporting drug approval. The FDA will then post to its website the minimum performance characteristics recommended for similar tests that may be used to select patients for treatment with the drug once the drug has been approved, the agency said. Laboratories can use that information "to guide their development of LDTs to identify specific biomarkers used for selecting cancer treatment," it said.
The FDA published a guidance explaining the need for the pilot and its intent to industry sponsors. The agency said in the guidance that based on the analytical performance of tests used to select patients for drugs in clinical trials, the pilot is aimed at "extrapolating the clinical validity" of tests that don't have FDA approval but that still may be used to identify best responders to a drug on the market.
"We believe this guidance and the launch of the pilot program are important steps towards addressing safety risks posed by the use of poorly performing laboratory developed tests," Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement. "The pilot aims to help by making transparent performance recommendations for diagnostic tests used to select certain oncology drug treatments."
The transparency is intended to facilitate better and more consistent performance of the tests, the agency noted. The initial phase of the program is expected to last up to a year, and the FDA will evaluate no more than nine drug sponsors for possible acceptance into the program.
The agency announced it would launch the pilot program last year.