The U.S. Food and Drug Administration (FDA) proposed a new rule regarding laboratory-developed tests (LDTs) aimed at ensuring safety and effectiveness.
Concerns that LDTs do not provide accurate test results or meet FDA standards prompted the proposal of the new rule. In fact, multiple data sources have suggested the problem has worsened and the risks of modern LDTs are greater than those of LDTs used decades ago.
The FDA is worried that patients will undergo unnecessary treatment or delay or go without proper treatment based on inaccurate results from LDTs.
“According to the Centers for Disease Control and Prevention, 70% of today’s medical decisions depend on laboratory test results,” said FDA Commissioner Robert M. Califf, MD. “Given the role these tests play in modern medical care, their accuracy and validity have a significant impact on public health.”
Currently, LDTs are not required to be registered with the FDA. The proposed rule will require laboratories that develop their own tests to register them with the FDA and meet all FDA requirements. The current approach will be phased out over the next five years.
“Through increased FDA oversight, the public, including patients and health care professionals, should have confidence that the tests they rely on are accurate,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “It is important that these tests be held to the same standards as other tests, while helping to ensure test makers have the flexibilities they need to continue innovating and developing tests critical to the advancement of public health.”
Sources: FDA, September 29, 2023. CNN, September 29, 2023.
