FDA takes actions to ensure the safety, effectiveness of LDTs

Earlier this week, on April 29, 2024, the United States FDA issued a press release announcing its actions toward ensuring the safety and effectiveness of laboratory developed tests (LDTs).

According to the administration, LDTs are considered in vitro diagnostic products (IVDs) for clinical use. These tests are designed, manufactured, and used within a singular clinical laboratory that adheres to predetermined regulatory guidelines. As the use of these tests expands, the healthcare industry has begun to implement them for the collection, preparation, and examination of human specimens, extracting measurements or insights about a patient's health that can be used to guide clinical decision-making.

Despite their utility, some experts are concerned about their safety and efficacy as they are only manufactured and utilized by one laboratory. Until now, companies have been allowed to use these tests as diagnostic tools without formal authorization if they meet specific standards.

However, amendments made to the Federal Food, Drug, and Cosmetics Act (FD&C Act) on Monday, April 29, 2024, put IVDs under the FDA’s purview, allowing the organization to enforce a formal regulatory process for LDTs. Over the next four years, the administration will phase out the current procedures used for LDTs.

“LDTs are being used more widely than ever before — for use in newborn screening, to help predict a person’s risk of cancer, or aid in diagnosing heart disease and Alzheimer’s. The agency cannot stand by while Americans continue to rely on results of these tests without assurance that they work,” said FDA Commissioner Robert M. Califf, MD, in the FDA press release. “The final rule announced today aims to provide crucial oversight of these tests to help ensure that important health care decisions are made based on test results that patients and healthcare providers can trust.”

According to the administration, recent data has shown that some LDTs do not perform as well as FDA-authorized tests or may provide inaccurate test results, suggesting some potential public health implications.

“Today’s action is a critical step toward helping to ensure the safety and effectiveness of LDTs, while also taking into account other public health considerations, including continued access to critical tests patients rely upon,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in the release. “Through targeted enforcement discretion policies for certain categories of tests manufactured by a laboratory, we expect patients and health care professionals will continue to have access to the tests they need while having greater confidence that the tests they rely on are accurate.”