As the regulatory landscape surrounding laboratory-developed tests (LDTs) continues to evolve, this session provides a timely reflection on where we have been, the lessons we’ve learned, and how to begin preparing for what may come next.
The session will begin with a brief overview of the recent events involving LDT oversight, highlighting key milestones that have shaped the present-day environment. The focus will center on real-world experiences from the laboratory medicine and pathology community. Together, we will explore lesson learned across several areas: regulatory readiness and interpretation of regulation, validation and verification processes including best practices for documentation, post-launch monitoring of LDTs, cross-functional collaboration within and external to our own institutions, strategic risk management, increasing visibility of LDT performance and benefits, and aligning with patient advocacy organizations.
The session will conclude with a look ahead to what the future may entail for potential LDT oversight, such as updates to CLIA and new legislative efforts. The goal is to better answer the question on our collective conscience: “How can we better position our laboratories for the next wave of change?” This session is well-suited for learners aiming to navigate compliance, continue leading in innovation, and advocating in the laboratory’s central role in patient care. The focus will be on practical insights and forward-looking strategies.
This session offers 1.0 CME/CMLE credit.
Faculty/Authors
Genzen Jonathan
Campbell Michelle
Physician Competencies: Patient Care, Systems-Based Practice
CME/CMLE Credit: 1.0
Estimated Completion Time: 1 hour
Format: Online Educational Activity
Accreditation Statement: The American Society for Clinical Pathology (ASCP) is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education (CME) for physicians. This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education (ACCME).
Credit Designation Statement: The American Society for Clinical Pathology (ASCP) designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Instructions
To claim CME/CMLE credit for the exercise, do the following:
- Review the Technical Considerations.
- Review the Faculty Disclosures.
- Click Go to Course to view an overview of the modules in this course.
- Click Access to begin the course.
- Submit the course Evaluation.
- Enter the maximum number of credits offered and click Claim CME to register credit.
Faculty Disclosure
Technical Considerations
Release Date: 11/19/2025
Review Date:
Expiration Date: