Challenges related to PD-L1 testing can be addressed through the lens of two key elements:
- an examination of what fit-for-purpose entails in the context of companion diagnostic testing, and
- an understanding of applicable principles that can be utilized in the validation of fit-for-purpose predictive biomarker assays by clinical laboratories. While long used for biomarker testing in the clinical trials realm, the application of “purpose” to biomarker testing in clinical immunohistochemistry is a relatively new construct. This presentation will focus on defining “purpose” in PDL1 companion diagnostic testing and how to apply relevant validation strategies to the implementation of such testing.
At the end of the session, participants will be able to:
- Describe fit-for-purpose principles relevant to PD-L1 biomarker testing.
- Apply pertinent aspects of laboratory validation to the implementation of PD-L1 biomarker testing
Speaker: Carol Cheung, MD, PhD, JD, University Health Network, University of Toronto
Target audience: Pathologists, Technologists, Residents
CanMEDS Roles: Medical Expert, Communicator
About the expert: Dr. Carol Cheung received her MD and completed her residency in Anatomical Pathology at the Faculty of Medicine, University of Toronto (UofT). She completed her PhD training in cellular and molecular biology at the Ontario Cancer Institute. She received her JD from UofT’s Faculty of Law. She is a consultant in Urologic Pathology at University Health Network (UHN) and an Associate Professor at UofT. She is the Medical Director of the Immunopathology Laboratory at UHN and founder of the webinar series “Epitopically Speaking…”. She serves on a number of committees including the Ontario Cancer Research Ethics Board, the Pathology Scientific Committee of the Institute for Quality Management in Healthcare, the Canadian Association of Pathologists’ National Standards Committee, the Canadian Standards Association’s Technical Committee on Medical Laboratory Quality Systems, the Standards Council of Canada’s Mirror Committee on clinical laboratory testing and in vitro diagnostic test systems.
This event is an Accredited Group Learning Activity (Section 1) as defined by the Maintenance of Certification Program of the Royal College of Physicians and Surgeons of Canada and approved by the CAP-ACP. You may claim a maximum of 1.5 hours per event attended. (credits are automatically calculated).
Declaration of Conflict of Interest:
Dr. Cheung is a member consultant on advisory boards for Agilent, Bayer, Bristol Myers Squibb, Merck.