Current Issues in PD-L1 Testing in Canada; Laboratory Perspective
Tue, 15 Sep 2020

Current Issues in PD-L1 Testing in Canada; Laboratory Perspective

The introduction of immunotherapy and PD-L1 IHC testing delivered many successes in clinical outcomes of highly aggressive tumors, but also created series of challenges for pathologists and pathology laboratories where PD-L1 IHC testing is being performed. Oncologists are also challenged in regard to proper biomarker selection for any given purpose.

This presentation focuses on the multifaceted issues related to currently widely used and also emerging PDL1
immunohistochemistry (IHC) assays in Canada. This presentation will address various aspects of so-called assay "interchangeability" and it will also propose abbreviated algorithm for pathologist and pathology laboratories to guide their strategies and assay selection for various purposes. It will also emphasize the role of various spheres of assay validation including clinical, diagnostic, and technical validation highlighting the need for team approach to test development for various different purposes (drugs, diseases) and ongoing quality assurance.

Target Audience:
Pathologists, Residents, Medical Students, Laboratory technologists in IHC laboratories

At the end of the meeting participants will be able to:

  • Identify which PD-L1 IHC assays are "fit-for-purpose".
  • Use specific criteria to identify which PD-L1 assays are interchangeable for any given specific purpose.
  • Distinguish between different spheres of validation of PD-L1 assays.
  • Distinguish between PD-L1 antibody and PD-L1 assay.

CanMEDS Roles: Medical Expert (the integrating role), Health Advocate

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 Canadian Association of Pathologists. You may claim a maximum of 1.0 hour (credits are automatically calculated).


Dr. Emina Emilia Torlakovic MD, PhD, FCAP

Dr. Emina Emilia Torlakovic obtained her M.D. at the University of Zagreb Medical School and her Ph.D. at the University of Oslo Medical School. She is board certified by The American Board of Pathology in Anatomic and Clinical Pathology with subspecialty boards in Hematopathology.

She is a professor at the Department of Pathology and Laboratory Medicine, College of Medicine, University of Saskatchewan, with previous appointment at the University of Toronto. She is a Division Head of Hematopathology, Saskatchewan Health Authority. She was a founding member of the NordiQC, has co-founded CIQC, and most recently founded Canadian Biomarker Quality Assurance (CBQA) as well as (inter)national academic quality assurance programs, which she is currently directing. Dr. Torlakovic is the Chair of the National Standards Committee for High Complexity Testing of the Canadian Association of Pathologists. This committee prepared and published several Canadian guidelines for standardization of IHC testing, with the most recently published guideline for PD-L1 testing for laboratories, and is a co-lead of an ongoing project aiming to harmonize testing for Hans' Algorithm in diffuse large B-cell lymphoma. Dr.
Torlakovic chaired the International Council for Standardization in Hematology (ICSH) Working Party for Standardization of Bone Marrow Immunohistochemistry, which developed international guidelines for bone marrow IHC and is currently chairing ICSH Working Party for standardization of CD34 testing in the bone marrow biopsy. She was/is a member of the ASCO/CAP expert panel that published guidelines for hormone receptor testing in breast cancer in 2010 and also an updated guideline in 2020. She is the President of the International Society for Immunohistochemistry and Molecular Morphology (ISIMM) and a Board Member of the International Quality Network
for Pathology (IQN Path). She is also currently leading several projects related to global standardization of controls in
diagnostic IHC.
Dr. Torlakovic is also known for a discovery of a sessile serrated adenoma and her classification of serrated polyps of the colon was a basis for current WHO classification of these polyps. Dr. Torlakovic has published over 100 peer reviewed manuscripts, authored a book on Bone Marrow Immunohistochemistry, and has lectured widely nationally and internationally on immunohistochemistry, quality assurance, and hematopathology.

Speaker Declaration of Conflict of Interest

  • Dr. Torlakovic does have a relationship with a for-profit and/or a not-for-profit organization to disclose; Consultant for Astellas Pharma
  • Dr. Torlakovic is a member on Merck Canada, BMS Canada, AstaZeneca Canada, Seattle
    Genetics and Abbvie advisory boards.
  • Dr. Torlakovic has received research grants from Merck, Pfizer, BMS and Roche

Co-Developed with Roche 
Co-development is defined by the Royal College as the process by which two or more organizations — at least one of which must be a physician organization — prospectively collaborate to develop and implement an accredited educational activity, learning resource or tool.

The physician organization (CAP-ACP) has ultimate authority over all decisions and is accountable to ensure that the administrative, educational and ethical accreditation standards for group learning activities are met.

This webinar was co-developed with Roche & CAP-ACP and was planned to achieve scientific integrity, objectivity and balance.

- last updated September 2020 -