Advocacy - Lab Advocate
Representative Neal Dunn, M.D. introduced the Enhancing Clinical Laboratory Innovation and Access Act of 2026, also known as the Enhancing CLIA Act, which would update the regulation of diagnostic testing services under the Clinical Laboratory Improvement Amendments.
The bill follows the rescission of FDA’s 2024 laboratory developed test rule and reflects continued congressional interest in how laboratory developed testing services should be overseen. ADLM has long maintained that oversight of laboratory developed tests should remain within a CLIA-based framework that supports patient access, innovation, quality, and safety.
According to Rep. Dunn’s office, the legislation would reaffirm that laboratory developed testing services are regulated by CMS under CLIA, establish a publicly accessible database with key performance and validation information, allow for voluntary third-party confirmation of validity, and create centralized error reporting. The bill is intended to modernize CLIA while avoiding duplicative requirements that could limit patient access to testing.
ADLM is reviewing the legislation and will continue working with member experts to evaluate how the proposal would affect clinical laboratories and the patients who rely on essential testing services. The association will continue to advocate for policies that reflect the realities of clinical laboratory practice, maintain high standards for quality and patient safety, and preserve access to innovative diagnostic testing.