The Food and Drug Administration (FDA) has proposed a new rule to regulate a wide range of laboratory medical tests, including those used for cancer diagnosis and detecting abnormalities in fetuses. The FDA argues that some of these tests are unreliable and could potentially harm patients. The proposed rule aims to gradually implement regulation over the next five years to ensure the safety and effectiveness of these tests. Currently, laboratory developed tests (LDTs), which are developed and used in a single laboratory as screening and diagnostic tools, do not have to be cleared by the FDA. However, if the rule is finalized, some tests, such as those involving cancer and genetic prenatal screening, may require FDA review before being offered to patients.
The FDA’s announcement has sparked opposition from groups representing academic medical centers and large commercial laboratories. They argue that FDA regulation would stifle innovation and that LDTs should not be considered medical devices like pacemakers or stents. Legislation to modernize the regulation of LDTs failed last year, prompting the FDA to propose its own rule. The FDA’s proposal has received praise from some experts, including Peter G. Lurie, president of the nonprofit Center for Science in the Public Interest, who called it a significant effort to fill a regulatory gap.
The FDA has expressed concerns about the increasing risks posed by LDTs, citing studies that show poor quality LDTs potentially causing harm to patients. Inaccurate results involving genetic noninvasive prenatal screening tests have also been a concern. The nonprofit Friends of Cancer Research has found substantial variability in diagnostic tests for identifying cancer patients who could benefit from immunotherapy. If the test results are inaccurate, patients could miss out on effective treatments or choose ineffective ones. While the FDA has long argued it has the legal authority to regulate LDTs, it has not used that power until now. The proposed rule could face opposition and potential legal challenges from critics, and the specific details of the new regulatory regime are still uncertain.