The Food and Drug Administration (FDA) has proposed a rule to regulate a range of laboratory medical tests, including those used for cancer diagnosis and fetal abnormalities. The FDA aims to phase in the regulation over the next five years to ensure the safety and effectiveness of these tests. Currently, many tests called laboratory developed tests (LDTs) are not subject to FDA review. Critics of the proposal, including academic medical centers and commercial laboratories, argue that FDA regulation would hinder innovation. However, the FDA believes that this is a significant gap in the healthcare system and that patients could receive incorrect treatment based on unreliable test results.
If the rule is finalized, the FDA would require certain tests, such as cancer and genetic prenatal screening, to undergo agency review before being offered to patients. Opposition to the proposal is expected, with potential lawsuits to block the final rule. The Centers for Medicare and Medicaid Services currently regulates clinical labs on cleanliness but does not monitor the accuracy of lab tests. LDTs have evolved from simple tests to complex ones that measure a variety of substances and provide insights into effective cancer treatments. The FDA has previously expressed concerns about the risks associated with LDTs, publishing case studies in 2015 and issuing warnings about inaccurate results in genetic prenatal screening tests in 2022.
The nonprofit organization Friends of Cancer Research has found substantial variability in diagnostic tests used for identifying cancer patients who could benefit from immunotherapy. These findings support increased regulation from the FDA. However, the FDA’s legal authority to regulate these tests has not been fully utilized in the past. The proposed rule marks a change in approach, although the exact details of the new regulatory regime remain uncertain. The FDA has indicated that alternative strategies may be considered, including grandfathering some tests or using a different approach with academic medical centers. The FDA will review public comments on the matter, while trade association AdvaMed supports increased regulation but prefers congressional legislation specifying the FDA’s authority.