#USA #Salt Lake City #ARUP Laboratories #FDA Regulations #Lab-Developed Tests

ARUP Laboratories Celebrates Court Ruling

On March 31, 2025, ARUP Laboratories expressed its gratitude towards a recent federal court ruling that favored both the American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP) by vacating the FDA's final rule regarding laboratory-developed tests (LDTs). This significant decision means that the FDA's attempts to regulate LDTs as medical devices are completely nullified, including the compliance deadlines that were set to begin on May 6, 2025.

Jonathan Genzen, MD, PhD, MBA, ARUP's chief medical officer and senior director of governmental affairs, highlighted the importance of this ruling for the healthcare industry. He stated, "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 the FDA’s final rule would have imposed on our industry and patient care." This sentiment was echoed by ARUP’s CEO, Andy Theurer, who emphasized the essential role LDTs play in providing quality patient care, particularly for those with rare diseases.

The court concluded that the existing laws under the Federal Food, Drug, and Cosmetic Act and the Clinical Laboratory Improvement Amendments clearly indicate that the FDA lacks the authority to regulate laboratory-developed test services. This ruling is a win for clinical laboratories and their patients, as it preserves access to critical diagnostic testing that might have been severely restricted under the FDA's rule.

ARUP Laboratories, a leading national reference laboratory affiliated with the University of Utah's Spencer Fox Eccles School of Medicine, offers an extensive range of over 3,000 tests, including both standard screenings and intricate molecular assays. The organization prides itself on its commitment to laboratory research and development, which is crucial for addressing evolving clinical needs.

In light of the federal court's decision, ARUP confirmed its readiness to continue providing high-quality testing services to its hospital and health system clients. The organization has emphasized that it will keep engaging with regulators to ensure an optimal regulatory framework that serves both the laboratory community and patients.

Genzen, who also contributed a declaration in support of ACLA's lawsuit against the FDA, acknowledged the critical advocacy efforts made by ACLA, AMP, and the broader community of pathologists and laboratory professionals. Their collective efforts were instrumental in achieving this significant legal victory, safeguarding access to vital tests that many patients depend upon.

Despite the positive ruling, ARUP remains vigilant, awaiting potential actions from the Justice Department regarding an appeal. In the meantime, the laboratory is committed to maintaining its strong quality management system and to ensuring its tests meet the highest standards of excellence.

As the regulatory landscape continues to change, ARUP Laboratories is dedicated to ongoing education and communication regarding these issues. They intend to advocate for clinical laboratories and to enhance their services for the patients who rely on their testing capabilities. For additional information about the FDA rule and related resources, ARUP encourages interested parties to visit their official website.

About ARUP Laboratories
Founded in 1984, ARUP Laboratories stands at the forefront of diagnostic and precision medicine innovation. Holding both ISO 15189 and CAP accreditation, ARUP ensures the delivery of reliable and important diagnostic information. For further details, visit www.aruplab.com.

Media Contact:
Bonnie Stray,
bonnie.stray@aruplab.com,
801-583-2787 ext. 2823