Letter to former FDA Commissioner Califf urging development of laboratory-developed test (LDT) regulations

Dear Dr. Califf,

We write on behalf of a broad group of public interest organizations to urge the Food and Drug Administration (FDA) to develop regulations for laboratory-developed tests (LDTs) in the event that legislation to regulate such tests does not progress in Congress.

As you know, LDTs are diagnostic tests that are developed and performed in a single laboratory. These tests have become increasingly important in clinical practice, but they put patients at risk and drive up healthcare costs when they perform poorly or are not supported by science.

To ensure that LDTs are safe and effective before they are marketed, the FDA has the authority to regulate them under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Historically, however, the agency has chosen not to use its authority to regulate most LDTs because early tests were fairly simple and used on a small number of patients. However, the availability and complexity of these tests have grown over time and many have been found to be inaccurate.