News | June 3, 2024

ARUP Files Declaration To Support Lawsuit Challenging The FDA's Rule To Regulate Lab-Developed Tests

Salt Lake City, UT /PRNewswire/ - ARUP Laboratories is backing a federal lawsuit filed by the American Clinical Laboratory Association (ACLA) challenging the FDA's final rule to regulate laboratory-developed tests (LDTs) as medical devices. The lawsuit states that the FDA does not have legal authority over medical testing services from Congress and asserts that regulating these services is unreasonable.

ARUP, one of the nation's four largest reference laboratories, with hospital and health system clients in all 50 states, joined three other national labs in filing declarations in support of the ACLA lawsuit. "I am deeply concerned about the FDA's final rule, the enormous costs it will impose on clinical laboratories, and the harm it will cause to patients across the nation," wrote Jonathan Genzen, MD, PhD, chief medical officer and senior director of governmental affairs, in ARUP's declaration. "The rule poses serious risks to patients by threatening to reduce access to safe testing services over time, which will disproportionately harm patients with rare diseases, underserved patient populations, patients with cancer, and children."

While the FDA's final rule, which was published earlier this month, supports enforcement discretion in some instances, such as for LDTs currently on the market and for those approved by the New York State Clinical Laboratory Evaluation Program (CLEP), Genzen raised additional concerns in ARUP's declaration. He said the final rule implies that lab tests not cleared or approved by the FDA are illegal and that laboratories have been violating the law for decades.

"The notion that laboratories and the professionals who run them are all engaged in unlawful conduct is absurd and, in my mind, shows that the FDA itself is not acting reasonably and within the scope of any lawful authority granted by Congress," Genzen wrote.

ARUP is a member of ACLA, and Andy Theurer, ARUP's CEO, is a member of the ACLA Board of Directors, which voted unanimously to pursue legal action seeking to strike down the FDA's final rule after thoughtful discussions.

"Our goal, as always, is to do all we can to deliver the highest quality testing and continually advance laboratory medicine to improve patient care," Theurer said. "We have grave concerns that the FDA rule will slow innovation over time."

ACLA's lawsuit does not ask for an emergency injunction, said Ashley Parrish, JD, attorney for ACLA. "We are not going to ask the court to make a quick decision or to immediately put a stop to the rule. We think this is an important case, and we want the court to have the time to consider the issues on a reasonable schedule," Parrish said.

Declarations such as ARUP's highlight the need for an urgent decision to protect patient care and are meant to help the court understand the impact of the rule through the eyes of experts in the field.

Read ARUP's declaration.

Read ACLA's lawsuit.

View ARUP's resources on the FDA's final rule, including a webinar, frequently asked questions, and a timeline for implementation.

About ARUP Laboratories
Founded in 1984, ARUP Laboratories is a leading national reference laboratory and a nonprofit enterprise of 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. ARUP serves clients in all 50 states, including many of the nation's top university teaching hospitals and children's hospitals, as well as multihospital groups, major commercial laboratories, group purchasing organizations, military and other government facilities, and major clinics. 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 CAP accredited.

Source: ARUP Laboratories

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