Immunohistochemistry: Past Foundations to Future Frontiers
Date: Tuesday March 31, 2026 from 12pm – 1:30pm Eastern Time
Speaker
Steve Bogen MD PhD
Department of Pathology & Laboratory Medicine
Tufts Medical Center
Boston Cell Standards Inc.
Dr. Bogen is a Board-Certified Clinical Pathologist, having graduated from the University of Chicago Pritzker School of Medicine (M.D.) and the Weizman Institute of Science (Ph.D.), with a post-graduate residency and research fellowship at the Brigham and Women’s Hospital. He is Adjunct Professor of Pathology and Laboratory Medicine at Tufts University School of Medicine and served as Medical Director, Clinical Chemistry Laboratory at Tufts Medical Center from 2010 - 2021. He is also an NCI-funded investigator whose research has focused principally on developing better laboratory diagnostic tools. Dr. Bogen previously developed the Artisan slide stainer and now serves as CEO of Boston Cell Standards.
Host
Carol C. Cheung MD, PhD, JD, FRCPC
Deputy Director, Canadian Biomarker Quality Assurance
Provincial Head and Professor | Pathology & Laboratory Medicine
College of Medicine, University of Saskatchewan | Saskatchewan Health Authority
Moderator
Emina Torlakovic MD, PhD, FCAP
Saskatoon, Saskatchewan
Founder and Director, Canadian Biomarker Quality Assurance
Head, Division of Hematopathology, Saskatchewan Health Authority
Professor, Pathology and Laboratory Medicine, University of Saskatchewan
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. 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 CBQAReadout.ca (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. 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 national and global standardization of clinical IHC applications.
Session Description
From its 1974 origin to today’s precision medicine era, this seminar traces the pivotal technical and regulatory milestones that shaped immunohistochemistry (IHC) practice, highlighting the distinctive quality challenges inherent to tissue-based assays.
Breakthroughs in the 1990’s such as automation and heat-induced epitope retrieval unleashed rapid adoption that outpaced IHC assay standardization, creating the early days of the IHC “Wild West”.
As biomarker-driven therapies became integral to treatment selection, expectations for analytic performance increased, bringing greater attention to inter-laboratory variability.
Clinical practice guidelines and proficiency testing programs have strengthened alignment for clearly negative and strongly positive cases; however, intermediate-expression cases continue to demonstrate meaningful variability across laboratories.
In response, the field is increasingly exploring a quality framework long used in other areas of laboratory medicine: mathematical standardization through statistical process control, calibration, and quantitative measurement of analytic sensitivity.
The seminar concludes with practical guidance for introducing the new quantitative quality tools into routine laboratory workflows to enhance IHC staining reproducibility and inter-laboratory alignment.
Learning Objectives
After this learning activity the participant will be able to:
- Distinguish immunohistochemistry as a qualitative stain versus a quantitative clinical assay (as described in the Magnani-Taylor editorial) and assess how this distinction affects quality practices in their own IHC laboratory.
- Explain how analytic sensitivity and lower limit of detection (LOD) affect staining and apply this understanding to design optimal quality procedures for their own laboratory.
- Compare and contrast the roles of calibration and daily controls in immunohistochemistry and evaluate how each contributes to quality in their laboratory.
- Compare and contrast the role of a clinical trial in establishing IHC assay performance standards versus the role of a reference standard.
- Critically assess limitations in FDA’s expectations for IHC companion diagnostic kit manufacturing in the context of existing IHC regulatory guidelines and explain why this places a higher quality burden on individual laboratories.