Dr. Jonathan Genzen stands in front of an officce window.

Jonathan Genzen, MD, PhD, MBA, ARUP chief medical officer and senior director of government affairs, explores key provisions of the Enhancing CLIA Act in a seven-part article series on LinkedIn to help inform the discussion around future oversight of laboratory-developed tests.

August 20, 2026

ARUP Laboratories’ Jonanthan Genzen, MD, PhD, MBA, chief medical officer and senior director of government affairs, recently published a seven-part article series on LinkedIn examining the Enhancing Clinical Laboratory Innovation and Access Act of 2026 (Enhancing CLIA Act).

The proposed legislation would 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. The bill represents the first legislative effort to address LDT regulation following the 2025 court decision in ACLA v. FDA, which vacated the FDA’s final rule on LDTs. ARUP applauded the court’s decision.

To help inform the discussion around future LDT regulation, Genzen explored key provisions of the bill and broader questions surrounding laboratory oversight in his article series. The articles reflect Genzen’s perspectives and are intended to encourage thoughtful discussion within the clinical laboratory community.

The series explores several topics that could shape the future of laboratory medicine, including:

  • The potential benefits and challenges of a centralized database for LDTs
  • Whether third-party review programs could be used to demonstrate analytical and clinical validity
  • The growing role of digital laboratory data, software, and artificial intelligence within a CLIA-regulated environment
  • Approaches for establishing and demonstrating clinical validity for LDTs
  • How adverse event reporting could be incorporated into a CLIA-based oversight framework
  • The potential impact of proposed reforms on reimbursement, coverage decisions, and companion diagnostics
  • Long-term consideration for CLIA modernization and the role of professional organizations in shaping future policy discussions

Read the series and join the conversation about the future of LDT oversight:

Part 1: A Centralized Database of LDTs

Part 2: Third-Party Review of LDTs

Part 3: Digital Laboratory Data, Software, and CLIA

Part 4: Clinical Validity and LDTs

Part 5: Adverse Event Reporting for LDTs

Part 6: Coverage, Reimbursement, and Companion Diagnostics

Part 7: Are Labs “At the Table” or “On the Menu”?

 

media@aruplab.com