Jonathan Genzen, MD, PhD, MBA

Jonathan Genzen, MD, PhD, MBA, ARUP’s chief medical officer and senior director of governmental affairs, along with three coauthors, created a detailed resource summarizing existing federal laws and regulations in the context of anatomic pathology.

March 17, 2025

A new article from ARUP Laboratories experts examines the FDA’s final rule on laboratory-developed tests (LDTs) in the context of anatomic pathology (AP). The lead author, Jonathan Genzen, MD, PhD, MBA, ARUP’s chief medical officer and senior director of governmental affairs, said the new rule significantly impacts AP. The authors of the article summarize existing federal laws and regulations, including those found in the Federal Register, the Code of Federal Regulations, the U.S. Code, and other sources. The article serves as a detailed resource for those responsible for AP testing to ensure compliance.

Genzen said that most articles related to laboratory regulation have focused on clinical pathology (CP), and there are very few resources focused exclusively on regulatory issues surrounding AP. In light of the 2024 final rule on LDTs from the FDA, he consulted with several AP colleagues to draft a review article that would highlight regulatory requirements across this essential discipline of pathology.

“Pathologists, laboratory directors, managers, and supervisors need resources that outline how AP testing is regulated at a federal level and to evaluate potential implications of future regulatory structures. This article is meant to be a helpful resource in which much of this is pulled together into one source,” Genzen said.

The paper is divided into sections, including:

  • A Brief History of In Vitro Diagnostic and Laboratory-Developed Test Regulation
  • The LDT Final Rule
  • FDA Regulation of In Vitro Diagnostics
  • NYS CLEP [New York State Clinical Laboratory Evaluation Program] and LDTs
  • Discussion

The FDA Regulation of In Vitro Diagnostics section also includes tables designed for quick reference to help readers understand medical device classifications, quality system regulations, and product codes specific to AP.

“This article summarizes information from multiple sources and presents it visually. It’s a starting point for anyone trying to understand very complicated regulations, and it includes links to the original laws and regulations for those who need more detailed information,” Genzen said.

Coauthors include Lauren J. Miller, MD, MJ, Michigan Medicine, Anton Rets, MD, PhD, ARUP medical director of Hematopathology, and Kajsa Affolter, MD, ARUP associate division chief of Anatomic Pathology, section head of Surgical Pathology, and subspecialty director of Pancreaticobiliary Pathology. The article was published in the American Journal of Clinical Pathology and can be found here.

 

Bonnie Stray, bonnie.stray@aruplab.com