Immunohistochemistry: Past Foundations to Future Frontiers Practical Tools to Elevate Quality and Reliability

Date: Wednesday March 31, 2026 from 1pm – 2:30pm Eastern Time

Host & Moderator

Carol C. Cheung MD, PhD, JD, FRCPC
Deputy Director, Canadian Biomarker Quality Assurance

Speaker

Steve Bogen MD PhD
Department of Pathology & Laboratory Medicine
Tufts Medical Center
Boston Cell Standards Inc.

Learning Objectives

After this learning activity the participant will be able to:

1. 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.
2. 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.
3. Compare and contrast the roles of calibration and daily controls in immunohistochemistry and evaluate how each contributes to quality in their laboratory.
4. Compare and contrast the role of a clinical trial in establishing IHC assay performance standards versus the role of a reference standard.
5. 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.