Advocacy - Lab Advocate
Federal policy discussions regarding laboratory-developed tests (LDTs) have entered a new phase following the rescission of the Food and Drug Administration’s 2024 laboratory-developed test rule.
ADLM opposed the rule because it would have created a duplicative regulatory framework for tests that clinical laboratories develop, validate, and perform to meet patient needs. These tests are frequently used when no appropriate commercially available alternative exists, including in cancer care, infectious disease testing, rare disease diagnosis, and other specialized areas.
Following a federal court decision vacating the rule, FDA restored its in-vitro diagnostic regulations to the framework that existed before the 2024 rule. ADLM welcomed this outcome as an important development for patient access and laboratory innovation while continuing to support strong requirements for laboratory quality and patient safety.
Congress is now considering whether the Clinical Laboratory Improvement Amendments (CLIA) should be updated. U.S. Rep. Neal Dunn, M.D., R-Fla., introduced the Enhancing Clinical Laboratory Innovation and Access Act of 2026, also known as the Enhancing CLIA Act. According to the sponsor, the legislation would reaffirm CMS oversight under CLIA and establish new mechanisms related to validation information, third-party review, and error reporting.
ADLM is currently reviewing the legislation with member experts. The association continues to support a CLIA-based framework that maintains high standards for quality and safety without creating unnecessary barriers that could delay or limit access to essential testing.