The Food and Drug Administration (FDA) released a final rule April 29, 2024, that regulates laboratory-developed tests (LDTs) the same as other in vitro diagnostic (IVD) tests. This was a response to concerns about the potential for inaccuracies and/or performance gaps in these tests compared to FDA-authorized tests.

The new rule categorizes all IVDs (including LTDs now) as medical devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory. In a news release, FDA reported that in five stages over the next four years the agency will end its long-standing “enforcement discretion” approach under which they were not enforcing complete regulatory oversight for LDTs.

The FDA acknowledged awareness of "numerous examples of potentially inaccurate, unsafe, ineffective or poor quality IVDs offered as LDTs that caused or may have caused patient harm, including tests used to select cancer treatment." The release said that without greater oversight, "patients may be more likely to initiate unnecessary treatment, or delay or forego proper treatment based on inaccurate test results or tests promoted with false or misleading claims.”

“We appreciate FDA action to modernize oversight of these tests and are hopeful this rule will increase focus on the need to balance rapid diagnostic innovation with patient safety and access,” said Everett E. Vokes, MD, FASCO, Board Chair for the Association for Clinical Oncology (ASCO). “The science and technology that enables precision medicine is evolving quickly, and we look forward to continuing our work with FDA and Congress to ensure safe and effective care is based on the most reliable information possible.”

In comments filed last year, ASCO said it supported FDA’s intent to modernize regulatory oversight, advocating for a single, flexible, risk-based framework. However, the final rule contained a number of exemptions, including:  

• Currently marketed LDTs that have not been modified.
• LDTs developed and used by a laboratory integrated within a health care system to meet unmet patient needs.
• LDTs approved by New York State Clinical Laboratory Evaluation Program (NYS CLEP).
• LDTs developed and used within the Department of Veteran Affairs and Department of Defense.
• LDTs for rare red blood cell antigens used in blood establishments (e.g. transfusion services).
• Other low-risk tests.

ASCO continues to believe that the best regulatory approach is a risk-based, single regulatory framework. Defining and regulating the highest risk tests, no matter where the test is developed, would provide consistency in standards and equitable patient access and care.

“ASCO is pleased to see these initial steps in regulating IVDs, ensuring that more patients can efficiently and accurately benefit from precision medicine, and we look forward to even more progress in the future,” Dr. Vokes said.

The first stage of the rule will begin one year after publication of the final rule in the May 6 Federal Register (on or about May 6, 2025).

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