Dr Clive Taylor is an Emeritus Professor of Pathology at the Keck School of Medicine, University of California. He is a pioneer in immunohistochemical (IHC) techniques for diagnosing surgical pathology, originally adapting these methods in Oxford, England, in 1972. He established a laboratory at the University of Southern California focused on lymphoma research and diagnosis. Dr Taylor has also served as a Trustee and President of the Biological Stain Commission (BSC), collaborating with the FDA to develop guidelines for IHC reagents and enhancing reproducibility.

Immunohistochemistry (IHC) entered the realm of Diagnostic Surgical Pathology as more specific type special stain. Today IHC is applied in that role in Anatomic Pathology laboratories worldwide. With the advent of actionable molecular biomarkers, IHC was pressed into service for detection and then quantification of such markers where the IHC result alone could determine therapy. In the latter application IHC was ‘repurposed' from a stain to an assay.  Unfortunately, the necessary pre-analytic, analytic and post-analytic changes did not evolve apace, resulting in poor clinical performance. Key technologies have now evolved to the point that deficits may now be addressed, thereby transmuting of IHC from a stain to an assay - "In Situ Proteomics."

Dr Rasmus Røge is a pathologist and Clinical Associate Professor affiliated with Aalborg University. His daily work focuses on hematopathology, specializing in the study and diagnosis of blood-related disorders. Dr Røge has been actively involved in the Nordic Immunohistochemical Quality Control (NordiQC) since 2012, an international external quality assessment scheme that serves diagnostic pathology laboratories worldwide. With more than 30 publications, his research primarily centers around quality assessment, methodology in Immunohistochemistry and introduction, validation and optimization of new biomarkers in pathology.

Ensuring the accuracy and reliability of laboratory testing is paramount. This talk explores the vital role played by NordiQC (Nordic Immunohistochemical Quality Control) in enhancing the quality and standardization of diagnostic testing in pathology laboratories. I will discuss NordiQC's objectives, operational approach, and the outcomes it has yielded. Additionally, I will introduce several valuable tools for IHC laboratories, which can be accessed on the NordiQC website.

Dirk Vossen leads a cross-functional team to develop diagnostic and clinical applications of digital pathology. His track record of creating value through innovation in digital and computational pathology spans the entire range of development, from ideation through validation and certification of medical devices, as well as commercialization strategies.

Dirk Vossen will introduce Visiopharm’s Qualitopix solution, which allows the monitoring and documentation of staining consistency. Learn about how easy Qualitopix fits into your workflow without the need for installation or integration. Be ready for new demands and regulations as the community is seeing the need for more regulation on IHC staining especially for predictive purposes. Dirk will also show the results of the first Qualitopix customers, who were able to identify unexpected shifts in their staining intensities. The labs already identified different reasons for the inconsistent staining, which will be explained.

Omar Z. Baba, M.D. is a Pathology Informatics Fellow at Henry Ford Health, Detroit, mentored by Dr J Mark Tuthill. A Clinical Pathologist trained at the American University of Beirut Medical Center in Lebanon, he has been at the forefront of pathology informatics, deeply engaged in multiple informatics operations at the department of Pathology and Lab medicine at HFH and notably leading a validation initiated on an AI-driven image analysis tool, which he presented at the 2023 PI Summit in Pittsburgh.

Henry Ford Health had implemented Qualitopix to investigate their staining consistency of ER, PR, HER2, Ki-67 and PD-L1. Dr. Omar Baba will show the results of the analysis of 1340 slides and how the monitoring using Qualitopix supported the lab to uncover unexpected shifts in their staining consistency.

Colin has spent the last twenty years developing, marketing, and commercializing a range of products for the IVD market, specifically tissue diagnostics. Colin is the founder and current CEO of HistoCyte laboratories. He studied Medical Microbiology at Newcastle University, specializing in immunology. His MSc focused on HER2 in breast cancer, involving the development of procedures for IHC controls. With this knowledge he and his colleagues started HistoCyte and developed a range of high-quality, reproducible, and cost-effective analyte control material for same-slide use in histopathology. HistoCyte was acquired by Atlas Antibodies in 2021.

In this webinar Colin will talk about the important role of cell lines together with Qualitopix in achieving staining consistency.

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 until 2021. He is also an NCI-funded investigator whose research has focused principally on developing better diagnostic tools. Dr. Bogen was previously the founder of CytoLogix Corporation. He now serves as CEO of Boston Cell Standards.

Published studies consistently demonstrate discrepancies in immunohistochemistry (IHC) staining from one laboratory to the next.  In practice, clinical IHC laboratories usually report consistent results on samples that are negative or strongly positive.  However, tumor samples with biomarker expression levels in the middle, between these two extremes, yield variable results among laboratories.  If the IHC test is for a targeted therapeutic, then these are the patients at greatest risk to be treated incorrectly.  The answer is to adopt the kind of quality assurance that is used in other parts of the clinical laboratory.  In this seminar, we describe the theory and practice of new IHC quality assurance tools.  Calibrators provide, for the first time, a direct readout on the analytic sensitivity of IHC assays.  Achieving a target lower limit of detection (LOD) guarantees an appropriate stain intensity.  Controls, on the other hand, are well-established in IHC.  However, labs are usually not aware if their controls have relevant biomarker concentrations, including whether the biomarker concentration is even in the assay dynamic range.  This presentation includes a description of both the science and clinical use of IHC calibrators and linear-range controls, including their objective quantification and use for statistical process control.  These more advanced quality assurance tools are required to ensure accuracy and consistency in patient testing.

Dr Fulton received his MD and PhD from the University of Minnesota and completed his residency in Anatomic Pathology at Stanford University. Following residency, he completed fellowships in Surgical Pathology and Immunodiagnosis at Stanford University and is board-certified in Anatomic Pathology. He is the founder and CEO of Array Science, LLC, a manufacturer of control and proficiency-testing material.  He holds multiple patents for making tissue and cell culture microarrays. He now works full-time at Array Science, while providing pathology support in the development of diagnostics, as well as various phases of clinical trials. Dr Fulton has served as a consultant and paid speaker for several pharmaceutical and biotechnology companies. 

Ki-67 is a widely used marker of cell proliferation. In his talk, Regan Fulton will give an overview of the biological function of the Ki-67 protein and its utility in different clinical indications. He will demonstrate current problems with the assay’s reproducibility and suggest solutions to improve the standardization of the assay using cell lines.  

Nils ‘t Hart is a thoracic pathologist with a position at Isala since 2009. Isala is a top clinical hospital in the center of The Netherlands. Since Nils finished his residency at UMCG, he is focusing on diagnostics in thoracic pathology, molecular diagnostics and predictive immunohistochemistry. He is interested in new developments in oncology, how to implement predictive markers in daily practice using AI and eager to do pathology research. Last but not least, he is always looking for new innovative methods to teach about his passion.

In this lecture, Dr. Hart will present a study on inter-laboratory HER2 variability and daily quality control across 40 Dutch pathology laboratories. He will explore the use of calibrators and cell lines, emphasize the importance of revalidation of HER2 tests, and discuss the advantages of Qualitopix as an AI-assisted tool for detecting staining inconsistencies in laboratories.

Paul J van Diest studied Medicine and did his PhD and pathology residency at VU University Medical Center in Amsterdam. After obtaining his Board certification (1996) he became Consultant Pathologist, Associate Professor (1999) and full Professor (2001). Since 2003 he is Head of the Department of Pathology at University Medical Center Utrecht. This department has gone fully digital and at the moment is involved in AI-research and implementation.  He is Adjunct Professor of Oncology at the Sidney Kimmel Oncology Center at Johns Hopkins, Baltimore, USA, serves on the editorial board of international journals, and has been active in several international societies.

UMC Utrecht has established an advanced digital pathology set up in their pathology lab. In this webinar, Professor van Diest will present the results of an extensive IHC stain and stainer evaluation performed using Qualitopix. The quantification of stain consistency enabled the lab to significantly improve their stain quality for HER2 and unveil staining variations based on their stainer.

Ralf Huss is a Professor of Pathology and currently the Managing Director and CEO of the Biotechnology Development Agency in Munich, Germany. Prior to this role, he was the founding director of the Institute for Digital Medicine at the University Hospital Augsburg, Germany. Dr. Huss is board-certified in anatomical, experimental, and molecular pathology, with over 30 years of experience in international academic institutions and the pharmaceutical industry with a focus on histopathology, immunology, cancer research, and digital medicine.

In his lecture, Dr. Huss will summarize the previous highlights of this extraordinary Masterclass from the need for quality control in precision pathology to the implementation of an automated and AI-based solution in a routine pathology workflow. With a special emphasis on the value of AI in controlling the robust performance of standardized IHC assays, Dr. Huss will advocate the importance to IHC tests to be acknowledged as an assay without increasing the burden on routine histopathology laboratories. On the contrary, such an approach could even compensate or at least forecast assay failure which allows early countermeasures from pre-analytical to post-analytical errors.