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UK NEQAS and Visiopharm

Monitor your IHC staining consistency between EQA runs with the UK NEQAS-Qualitopix® initiative

Gain confidence in the reproducibility
your assays and receive alerts when drifts occur

In a groundbreaking collaboration, Visiopharm and UK NEQAS ICC & ISH are setting new standards for IHC testing, harnessing cutting-edge AI technology alongside rigorous proficiency testing. The Qualitopix® solution enables continuous measuring, monitoring, and documentation of staining consistency, promptly identifying, and addressing any deviations. Hereby, standardization of staining in between UK NEQAS ICC & ISH’s semi-annual detailed assessments can be ensured.


of laboratories fail to meet minimum proficiency standards for critical predictive markers2.

2-3 times

EQA runs happen typically 2-3 times a year, making consistent IHC staining maintenance difficult


higher error rate. For decades, the reported error rates of IHC staining have been 10 times higher than error rates for other clinical tests, risking or causing wrong diagnosis.

"The present figures concerning IHC testing accuracy are worrying. The direct link between test precision and patient outcomes cannot be overstated. This joint initiative, combining Visiopharm's AI-driven internal quality control with our external quality assessment, aims to significantly enhance testing quality, a critical factor in delivering optimal patient care."

- Mr. Andy Dodson, Director of UK NEQAS ICC & ISH

Sign up to access our interactive online demo

This is how Qualitopix® works

No local installation or integration required to get started, an intuitive workflow and a fast turnaround time make it easy for you to add Qualitopix to your workflow.


Qualitopix worflow - RefMat

Purchase standardized
reference material

Cell line (Histocyte, ArrayScience)
Coming soon: Microbead controls and calibrators (BCS).


Qualitopix workflow - slides

Place on slides and stain

Follow your routine staining protocol.


Qualitopix workflow - scanner

Scan slides

Slides can be scanned on various scanners.


Qualitopix workflow - upload

Upload images and metadata

No installation required. Just drag and drop the images with key metadata.


Qualitopix workflow - ReviewPlot

Receive Quantitative results

Shortly after upload, you will receive results and will be notified if a test requires your attention.


Qualitopix workflow - Troubleshoot


If you do encounter outliers, Qualitopix provides tools to streamline the troubleshooting process and identify the root cause.

Trust your staining through AI driven quantification and monitoring

Sign up to access our interactive online demo


Here are some publications/papers about Qualitopix®


Qualitopix: Artificial intelligence-based quantitative quality assurance of immunohistochemistry staining-The Henry Ford Health experience


Improving PD-L1 quality control using a dynamic range cell line and Qualitopix analysis


Inter-laboratory variability of HER2 low analysis using artificial intelligence

“Our analysis revealed a 26-34% rate of outliers at 1 SD for the five stains, 10 times higher than the currently reported number from our lab.” Omar Baba, American Journal of Clinical Pathology - Qualitopix: Artificial intelligence-based quantitative quality assurance of immunohistochemistry staining-The Henry Ford Health experience 


1 Vyberg M et al. Immunohistochemical expression of HER2 in breast cancer: socioeconomic impact of inaccurate tests. BMC Health Serv Res., 15:352, August 2015 Read full paper

2 Nielsen S et al., Lessons Learned, Challenges Taken, and Actions Made for “Precision” Immunohistochemistry. Analysis and Perspectives From the NordiQC Proficiency Testing Program. Applied Immunohistochemistry & Molecular Morphology, 31(7):p 452-458, August 2023 Read full paper

Meet your speakers

Clive Taylor

Clive Taylor

Emeritus Professor at Keck School of Medicine, USA

Dr Clive Taylor is a 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.
Dr Rasmus Røge, MD, PhD

Dr Rasmus Røge, MD, PhD

Hematopathologist and Clinical Associate Professor, Aalborg University

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.

Prof Ralf Huss

Prof Ralf Huss

BioM Biotech Cluster Development GmbH & University Hospital Augsburg, Germany

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.

Omar Baba

Omar Baba

MD, Clinical Pathologist, Henry Ford Hospital, USA

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.

Nils 't Hart

Nils 't Hart

Pathologist, Isala Hospital, The Netherlands

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.
Paul J van Diest

Paul J van Diest

Professor, UMC Utrecht, The Netherlands

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.
Colin Tristram

Colin Tristram

CEO, Histocyte, UK

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.
Steve Bogen

Steve Bogen

CEO, Boston Cell Standards, USA

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.
Regan Fulton

Regan Fulton

CEO, Array Science, USA

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. 

Michael Grunkin

Michael Grunkin

CEO, Visiopharm, Denmark

Dr Michael Grunkin is founder and CEO of Visiopharm. He received his Ph.D in image analysis from the Technical University of Denmark in 1993. His post-doctoral work was carried out on Massachusetts Institute of Technology and Harvard Medical School, where he combined a strong theoretical and practical background in image analysis with applications from the life-sciences.
Dirk Vossen

Dirk Vossen

CDO, Visiopharm, the Netherlands

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.

Posters being presented at AACR

Title: TP53 gain-of-function mutation modulates the immunosuppressive microenvironment in non-HPV associated oral squamous cell carcinoma

Session Date and Time: Sunday Apr 16, 2023 1:30 PM - 5:00 PM

Published Abstract Number: 619

Poster Board Number: 20

Poster Section: 21

Authors: Y. Shi et al. from Xi'an Jiaotong University, China,; with MD Anderson Cancer Center

Title: Multiplex immunofluorescence and image analysis to investigate the role of the immune contexture and fibroblast activation for tumor cell budding in colorectal cancer

Session Date and Time: Sunday Apr 16, 2023 1:30 PM - 5:00 PM

Published Abstract Number: 1018

Poster Board Number: 28

Poster Section: 41

Authors: D. Zielinski et al. from Discovery Life Sciences

Title: Precision immuno-oncology (IO) ISH/IF multiplex panel: Spatial detection of cytokines and IO biomarkers

Session Date and Time: Monday Apr 17, 2023 1:30 PM - 5:00 PM

Published Abstract Number: 2322

Poster Board Number: 3

Poster Section: 45

Authors: B. Dennison et al. from Lanterne Dx

Title: Multiplex proteomics profiling with the imaging mass cytometry (IMC) identifies immune cell phenotypes associated with high NOS2/COX2 expression in ER- negative and TNBC patients

Session Date and Time: Tuesday Apr 18, 2023 1:30 PM - 5:00 PM

Published Abstract Number: 3588

Poster Board Number: 13

Poster Section: 3

Authors: M. Pore et al. from NCI Frederick, MD

Title: A comprehensive guided workflow for highplex imaging, tissue segmentation, and multiplex cellular phenotyping for tumor microenvironment analysis

Session Date and Time: Tuesday Apr 18, 2023 1:30 PM - 5:00 PM

Published Abstract Number: 4625

Poster Board Number: 15

Poster Section: 4

Authors: B. O’Neill et al. from Visiopharm; with Standard Bio Tools