On April 10, the CAP responded to the Senate Health, Education, Labor, and Pension (HELP) Committee and ranking member Sen. Bill Cassidy’s (R-LA) request for information regarding oversight and reforms to clinical diagnostics. In a letter, the CAP outlined its positions on the oversight of LDTs, legislative updates to CLIA, alternatives to the Food and Drug Administration (FDA) rulemaking, and artificial intelligence in diagnostics. Overall, the CAP continues to advocate for an approach to oversight that protects patients, ensures continued access to safe and innovative diagnostic tests, and is the least burdensome for pathologists and their laboratories.

Oversight of LDTs

The CAP believes that a legislative and regulatory framework for LDTs should include a role for the FDA according to a test's risk level to a patient. This can be done by restricting direct FDA regulatory oversight to the highest-risk LDTs, providing flexibility in FDA oversight of lower-risk LDTs and, where possible, leveraging the existing CLIA framework to avoid duplication in regulatory requirements.

CAP Opposition to CLIA ‘Modernization’

The CAP is strongly opposed to opening up CLIA for legislative changes to allow for oversight of LDTs. Congress and previous Administrations, as well as the current Administration, have firmly held that oversight of LDTs should remain with the FDA due to the agency’s expertise in

approving diagnostic tests for patients. In January 2024, the FDA and CMS clearly delineated each agency’s authority and areas of expertise: the CMS regulates laboratory operations for patient testing, and the FDA oversees test development and production.

Alternative Proposals to FDA Rulemaking

The CAP supports the Verifying Accurate Leading-edge IVCT Development Act of 2023.

Should the FDA fail to modify the proposed rule to incorporate all the CAP’s requested changes, Congress should pass legislation to regulate laboratory developed tests. Any legislation Congress passes should create a tiered risk-based structure for oversight of LDTs, include a targeted role for the FDA, introduce significant flexibility in LDT oversight, and utilize whenever possible current laboratory reporting requirements. Legislation such as H.R. 2369, the VALID Act of 2023 (“VALID”) utilizes such a tier-based approach.

Artificial Intelligence and Diagnostics

The CAP urges a balance in the advancement in technology and innovation with patient safety and regulatory oversight. Regulations for AI will need to ensure the appropriate levels of safety can be reliably determined and maintained. The CAP has advocated for a risk-based approach to the FDA in ensuring safe and effective devices using any AI/ML technologies because of the myriad of uses in pathology and laboratory medicine, from digital pathology to next generation sequencing.