Significance of Pathologist’s Readout for IHC Biomarker Assays: Art or Science?

“Pathologist’s readout” and “pathologist’s interpretation” are the two distinct components of any IHC biomarker assay, irrespective if assays are used for diagnostic, prognostic, or predictive purposes. These two components belong to the two different phases of the IHC assay; “pathologist’s readout” is the last component of the analytical phase, while “pathologist’s interpretation” is a part of the post-analytical phase. These two components require education and training, both during the residency training in pathology as well as during pathology practice when new assays or new purposes for the IHC assays are developed. Pathologist’s readout, being a part of analytical phase, requires validation before the assay is put to clinical use. This requirement is especially important for predictive IHC biomarker assays.

At the end of the session, participants will be able to:

  • Distinguish between “pathologist’s readout” and “pathologist’s interpretation” as components of any IHC biomarker assay.

Target audience: Pathologists, Residents, Medical Students
CanMEDS Roles: Medical Expert

About the Expert: 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 clinical professor at the University of Saskatchewan and a Division Head of Hematopathology, SHA. She was a founding member of the NordiQC, cofounded CIQC, and most recently founded and directs Canadian Biomarker Quality Assurance (CBQA) and CBQAReadout.ca, academic QA programs. Dr. Torlakovic is the Chair of the National Standards Committee for High Complexity Testing of the CAP-ACP. She is the President of the International Society for Immunohistochemistry and Molecular Morphology and a Board Member of the International Quality Network for Pathology. She is also currently leading several national and international projects related to quality assurance of IHC biomarker assays.

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. Torlakovic is a member consultant on advisory boards for Merck, BMS, Roche, Pfizer, Agilent Technologies.
  • Educational and operating grants for CBQA/CBQAReadout.ca from Diaceutics, Roche, Merck, Pfizer, BMS.
  • Scientific collaborator for Boston Cell Standards.