Navigating FDA oversight of LDTs: Insights and implications from ADLM 2024

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Overview

In May 2024, the U.S. Food and Drug Administration (FDA) issued a final rule that will significantly expand its oversight of laboratory developed tests (LDTs). This regulatory change stands to impact clinical laboratory processes, the delivery of care, and patient outcomes in profound ways. This educational activity compiles a series of highly attended sessions presented at ADLM 2024 and features leading experts in the field.

In these sessions, faculty members provide comprehensive insights into the latest developments surrounding the final rule, detailing its implications for laboratory operations and the potential direct and indirect effects on healthcare delivery. Experts will also discuss how clinical laboratorians can proactively prepare for these changes, evaluating the anticipated financial costs, staffing requirements, and broader healthcare implications should the rule be implemented. Join us to gain crucial knowledge that will equip you to navigate this evolving landscape in laboratory medicine.

Target audience

This activity is designed for physicians, lab supervisors, lab directors (and/or assistant directors), lab managers (supervisory and/or non-supervisory), fellows, residents, in-training individuals, nurses, payors, healthcare administrators, and other laboratory professionals overseeing/conducting steps in clinical laboratory medicine that development, utilize, and/or rely on laboratory developed tests.

Learning objectives

At the end of this activity, participants will be able to:

• Summarize the integral roles of laboratory developed tests in healthcare delivery and the potential impacts of FDA oversight from laboratory, provider, and patient perspectives.
• Develop a framework to communicate changes in clinical testing services and patient testing based on reduced access to laboratory-developed tests.
• Anticipate how restricted access to laboratory-developed tests will impact clinical outcomes in terms of finance costs, staffing resources, and healthcare delivery for adult and pediatric populations.
• Compare the regulatory structure of the EU IVDR to the US Food and Drug Administration proposed regulation of laboratory developed tests (LDTs) and recognize their threat to lab operations and resources.

Course outline

Participants will complete a brief survey at the beginning and end of the course.

Operationalizing changes to LDT oversight: Building roadmaps when the rubber hits the road (90 minutes)
Moderator: Mark Marzinke, PhD, DABCC, FADLM, Johns Hopkins University

• Developing Tools to Manage Decreased Access to LDTs
  Stephen Master, MD, PhD, FADLM, Children's Hospital of Philadelphia
• LDTs as Medical Devices? Strategies for Prioritization and Regulatory Compliance
  Jonathan Genzen, MD, PhD, ARUP Laboratories
• Biomarkers and Bureaucracy: Impact of FDA Regulation of Molecular Diagnostics LDTs
  Eric Konnick, MD, University of Washington

ADLM Healthcare Forum: The impact of LDT oversight on the delivery of care(90 minutes)
Moderator: Joe Wiencek, PhD, DABCC, NRCC, FADLM, Vanderbilt University Medical Center

• The Necessity of LDTs in Pediatric Care: Lack of Access Leads to Compromised Patient Care
  Patricia Jones, PhD, DABCC, FADLM, University of Texas Southwestern Medical Center
• LDT Oversight by the Experts: Finding Alternatives to the Proposed FDA Rule
  Dennis Dietzen, PhD, DABCC, FADLM, Washington University School of Medicine

How FDA oversight of LDTs will affect patient care: A conversation with the American Medical Association, the Children’s Hospital Association, and a patient advocate(90 minutes)
Moderator: Octavia Peck Palmer, PhD, FADLM, University of Pittsburgh Medical Center

• The New FDA Rule on LDTs: A Physician Perspective
  Geoff Hollett, PhD, American Medical Association
• What the New FDA Rule Means for Pediatric Care
  Meghan Delaney, DO, MPH, Children's National Hospital
• The Value of LDTs: A Parent’s Perspective
  Sarah Braswell, Caregiver and Patient Advocate
• Additional Panelists
  Olivia Braswell, Patient
  Dennis Dietzen, PhD, DABCC, FADLM, Washington University School of Medicine

International regulatory considerations for laboratory developed tests: Opportunities and risks for patient care(90 minutes)
Moderator: Christina Lockwood, PhD, DABMGG, DABCC, University of Washington

• Impact of Diagnostic Regulations on Laboratory-Developed Tests in the United States
  Christina Lockwood, PhD, DABMGG, DABCC, University of Washington
• Regulatory Considerations for Laboratory-Developed Tests from the European Perspective
  Patrick Bossuyt, PhD, University of Amsterdam/Amsterdam UMC

Accreditation

ADLM offers ACCENT® continuing education credit to laboratory professionals to document their continuing education and meet requirements for licensure or certification. This educational activity is designated for a maximum of 6.0 ACCENT credits. Learners should claim only the credit commensurate with the extent of their participation in the activity. ADLM is also accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. This educational activity is designated for a maximum of 6.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Click here to view full accreditation information.

Expiration date: December 31, 2027

Participants are not able to claim continuing education credit for this activity after December 31, 2027.