FDA Launches Programs to Reduce Risk of Cancer Biomarker Testing

Last week, on June 20, 2023, the United States Food and Drug Administration (FDA) launched a pilot program to reduce the risk of laboratory-developed tests to identify cancer biomarkers. The program aims to address some sponsors of oncology drugs that use in vitro diagnostics to confirm patient eligibility for the treatment.

“We believe this guidance and the launch of the pilot program are important steps toward addressing safety risks posed by the use of poorly performing laboratory-developed tests,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in the FDA press release. “The pilot aims to help by making transparent performance recommendations for diagnostic tests used to select certain oncology drug treatments.”

The program addresses concerns by the FDA regarding some unauthorized laboratory-developed tests (LDTs) used to make treatment decisions. FDA officials are concerned about the accuracy and reliability of these tests, arguing that their performance is questionable compared to FDA-approved and monitored tests.

As part of the pilot program, the researchers will request that drug manufacturers include information on the tests used to enroll patients in clinical trials. The FDA will require more detailed data submission since clinical trial data is submitted to support drug approval.

The organization will develop standards for similar laboratory tests to guide future development using the information collected from these manufacturers. For the next year, the FDA will gather data from nine drug sponsors for the program.

“Today’s pilot program launch, and corresponding guidance publication, is a step forward in improving cancer care for patients,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, in the release. “This pilot program demonstrates the FDA’s commitment to collaborating with the pharmaceutical industry and other key stakeholders to address concerns and questions around the use of unauthorized diagnostics.”