October 2, 2023- The Food and Drug Administration (FDA) announced a rule that aims to ensure the safety and effectiveness of laboratory developed tests (LDTs). Examples of the tests being regulated include diagnostic COVID-19, blood lead levels, breast cancer genes, etc., that will soon be held to higher accuracy standards by the FDA.
Testing labs are regulated by the Centers for Medicare and Medicaid Services, but the agency does not evaluate the accuracy of tests. According to the proposed FDA rule, the agency is concerned about the quality of lab tests and wants to regulate tests made in labs the same way medical devices are regulated.
The lab testing industry opposes the proposal, and according a statement from the American Clinical Laboratory Association, the FDA regulation of lab tests should have come through legislation.
The FDA says that the rule helps address the issue of patients potentially initiating unnecessary treatment, or delay or forgo treatment based on inaccurate test results which could result in harm and worsening illness.