The Enhancing CLIA Act of 2026 represents the first legislative response to a 2025 court decision regarding laboratory-developed tests.
Clinical laboratories, including ARUP Laboratories, are reviewing newly introduced federal legislation intended to modernize the oversight of laboratory-developed tests (LDTs) under the Clinical Laboratory Improvement Amendments (CLIA), the primary framework for regulating laboratory testing in the US.
Representative Neal Dunn, R-Florida, introduced the Enhancing Clinical Laboratory Innovation and Access Act of 2026 on May 19. The bill is the first legislative effort to address LDT oversight since a 2025 court decision in ACLA v. Food and Drug Administration (FDA). That ruling vacated an FDA final rule that would have regulated LDTs as medical devices, instead reaffirming CLIA as the regulatory authority.
“This is an important proposal that will hopefully spark crucial conversations across the clinical laboratory community,” says Jonathan Genzen, MD, PhD, MBA, ARUP Laboratories’ chief medical officer and senior director of governmental affairs, in a release. “I’m personally grateful that a physician member of Congress introduced this bill, as it reinforces the importance of quality, transparency, and innovation in laboratory tests used for patient care.”
The proposed legislation aims to build upon the CLIA framework to improve innovation and transparency within laboratory medicine. Key provisions of the bill include a two-year delay for the implementation of new requirements following enactment. It also establishes a voluntary pathway for laboratories to maintain any existing medical device clearances or approvals.
Clinical laboratories are essential for diagnosing disease, guiding treatment decisions, advancing precision medicine, and supporting public health. According to ARUP Laboratories, a national reference laboratory currently reviewing the bill, modernization of CLIA is intended to ensure patients continue to have access to high-quality testing.
The company plans to monitor developments related to the Enhancing CLIA Act and provide additional educational resources as the legislative process continues.
Photo caption: Jonathan Genzen, MD, PhD, MBA, ARUP’s chief medical officer and senior director of governmental affairs, said the Enhancing CLIA Act is an intriguing step forward in considering future oversight of laboratory-developed tests.
Photo credit: ARUP Laboratories
