Emina Torlakovic

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cIQc Non-Small Cell Lung Cancer EQA for PD-L1
CIQC conducted pilot/educational run for proficiency testing for PD-L1. Although the number of participants was small, the review of the results revealed number of pitfalls related to the design of the proficiency testing materials and the analysis of the achieved results. This presentation reviews lessons learned from the experience.
 
Immunohistochemistry Test Performance Characteristics
 All laboratory tests have test performance characteristics (TPCs), whether or not they are explicitly known to the laboratorian or the pathologist. TPCs are thus also an integral characteristic of immunohistochemistry (IHC) tests and other in situ, cell-based molecular assays such as DNA or RNA in situ hybridization or aptamer-based testing. Because of their descriptive, in situ, cell-based nature, IHC tests have a limited repertoire of appropriate TPCs. Although only a few TPCs are relevant to IHC, proper selection of informative TPCs is nonetheless essential for the development of and adherence to appropriate quality assurance measures in the IHC laboratory. This paper describes the TPCs that are relevant to IHC testing and emphasizes the role of TPCs in the validation of IHC tests. This is part 2 of the 4-part series “Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine.”
 
Technical Validation of IHC Assays in Clinical IHC Laboratories 
Validation of immunohistochemistry (IHC) assays is a subject that is of great importance to clinical practice as well as basic research and clinical trials. When applied to clinical practice and focused on patient safety, validation of IHC assays creates objective evidence that IHC assays used for patient care are “fit-for-purpose.” Validation of IHC assays needs to be properly informed by and modeled to assess the purpose of the IHC assay, which will further determine what sphere of validation is required, as well as the scope, type, and tier of technical validation. These concepts will be defined in this review, part 3 of the 4-part series “Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine.”
CV

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 an associate professor at the Department of Laboratory Medicine and Pathobiology, Faculty of Medicine, University of Toronto and practices as a staff hematopathologist in the Department of Laboratory Hematology at the University Health Network. She was a founding member of the NordiQC and also co-founded CIQC, which she is currently co-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. Dr. Torlakovic chairs the International Council for Standardization in Hematology Working Party for Standardization of Bone Marrow Immunohistochemistry, which developed international guidelines for bone marrow IHC. She was also a member of the ASCO/CAP expert panel that published guidelines for hormone receptor testing in breast cancer. She is also currently leading 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 is recently adopted for WHO classification.

Dr. Torlakovic has published over 80 peer reviewed manuscripts, authored a book on Bone Marrow Immunohistochemistry, and has lectured widely nationally and internationally on immunohistochemistry, quality assurance, and hematopathology.