Connect Sign In
The U.S. District Court for the Eastern District of Texas today struck down the FDA’s final rule to regulate laboratory-developed tests.
SALT LAKE CITY—ARUP Laboratories applauded today’s federal court ruling in favor of the American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP), vacating in its entirety the FDA’s final rule to regulate laboratory-developed tests (LDTs) as medical devices. As a result of the decision, the rule and its compliance deadlines, the first of which would have occurred on May 6, 2025, are no longer in effect.
“ARUP is grateful to the U.S. District Court in Texas for the careful consideration of this topic and the recognition of the sweeping changes to our industry and patient care that the FDA’s final rule would have created,” said Jonathan Genzen, MD, PhD, MBA, ARUP’s chief medical officer and senior director of governmental affairs.
Genzen, who contributed a declaration to ACLA’s lawsuit against the FDA, added that ARUP is also grateful to ACLA, AMP, and the community of pathologists and laboratory professionals for their engagement and advocacy on behalf of clinical labs and the many patients who would have been denied access to critical testing under the FDA rule. ACLA and AMP filed separate lawsuits, which were later administratively consolidated.
“LDTs play a vital role in delivering the best patient care, particularly for patients with rare diseases,” ARUP CEO Andy Theurer said. “They’re also vital to ongoing innovation in laboratory medicine to meet ever-evolving clinical needs.”
“We remain confident in our ability to deliver the best quality tests available to our hospital and health system clients and their patients,” he added.
The court concluded that “the text, structure, and history of the Federal Food, Drug, and Cosmetic Act (FDCA) and the Clinical Laboratory Improvement Amendments (CLIA) made it clear that the FDA lacks the authority to regulate laboratory-developed test services.”
ARUP will wait to see whether the Justice Department appeals today’s ruling. The company has a robust quality management system and has experience working with the New York Clinical Laboratory Evaluation Program (CLEP) for test approval. ARUP made providing education and communication about the final rule a priority and will continue to advocate on behalf of clinical labs.
“We recognize that regulatory frameworks will evolve, and we will continue to engage with those who create regulations to best serve our clients and patients,” Genzen said.
Read the court’s memorandum opinion and order.
Read the court’s final judgment.
Genzen’s declaration on behalf of ARUP is available here.
Additional information and resources about the FDA rule can be found on this page at aruplab.com.
About ARUP Laboratories
Founded in 1984, ARUP Laboratories is a leading national reference laboratory and a nonprofit enterprise of the University of Utah Spencer Fox Eccles School of Medicine 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.
ARUP Media Contact
Bonnie Stray, bonnie.stray@aruplab.com, 801-583-2787 ext. 2823
