Clinical Labs Review Proposed Legislation To Modernize Oversight of Lab-Developed Tests Under CLIA

SALT LAKE CITY, June 16, 2026 /PRNewswire/ -- Clinical laboratories, including ARUP Laboratories, are reviewing newly introduced federal legislation to modernize oversight of laboratory-developed tests (LDTs) under the Clinical Laboratory Improvement Amendments (CLIA), the framework for regulation of laboratory testing in the United States.

On May 19, Rep. Neal Dunn, R-Florida, who is a physician, introduced the Enhancing Clinical Laboratory Innovation and Access Act of 2026 (Enhancing CLIA Act). The bill represents the first legislative effort to address LDT oversight following the 2025 court decision in ACLA v. FDA, which vacated the FDA's final rule that would have regulated LDTs as medical devices, reaffirming CLIA as the primary regulatory authority. ARUP applauded the court's decision.

The proposed legislation builds on the CLIA framework and has the potential to strengthen both innovation and transparency in laboratory medicine.

"This is an important proposal that will hopefully spark crucial conversations across the clinical laboratory community," said Jonathan Genzen, MD, PhD, MBA, chief medical officer and senior director of governmental affairs. "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."

Key provisions of the legislation would:

• Reaffirm, upon enactment, that LDTs are professional medical services regulated by the Centers for Medicare and Medicaid Services (CMS) under CLIA
• Require CMS to establish a transparent and publicly accessible database with key information regarding LDTs, including summaries of performance specifications and validation information
• Require laboratories to submit reports of test errors that caused serious harm
• Leverage existing review and oversight mechanisms to allow laboratories to obtain optional confirmations from recognized third parties that an LDT is analytically and clinically valid

The bill would also delay implementation of new requirements for two years following enactment and establish a voluntary pathway for labs to maintain any existing device clearances and/or approvals.

Clinical laboratories play a vital role in diagnosing disease, guiding treatment decisions, advancing precision medicine, and supporting public health. Thoughtful modernization of CLIA is essential to ensure patients continue to benefit from innovative, high-quality testing.

ARUP has actively engaged in education and advocacy on LDT policy and will continue to monitor developments related to the Enhancing CLIA Act. Genzen said the company plans to share additional information and educational resources soon.

About ARUP Laboratories

Founded in 1984, ARUP Laboratories is a leading national reference laboratory and a nonprofit enterprise of the Spencer Fox Eccles School of Medicine at the University of Utah and its Department of Pathology. ARUP offers more than 3,000 tests and test combinations, ranging from routine screening tests to esoteric molecular and genetic assays. In addition, ARUP is a worldwide leader in innovative laboratory research and development, led by the efforts of the ARUP Institute for Research and Innovation in Diagnostic and Precision Medicine™. ARUP is ISO 15189 and CAP accredited. For more information, visit www.aruplab.com.

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SOURCE ARUP Laboratories