Solution combining first AI-Driven IHC Levey-Jennings software with first quantitative IHC reference materials will enable labs to meet proposed regulatory changes

Visiopharm and Boston Cell Standards today announced a partnership to develop a joint technology solution that enables labs to meet key provisions of regulatory changes proposed in a groundbreaking editorial recently published in Archives of Pathology & Laboratory Medicine.

In a July 2023 Archives online editorial, Dr. Barbarajean Magnani and Dr. Clive Taylor proposed that clinical immunohistochemistry (IHC) quality assurance requirements mirror those of all other clinical laboratory assays. If adopted, the proposal would represent a significant shift in the IHC lab regulatory landscape, requiring labs to incorporate rigorous assay control methods and calibration.

Modern clinical laboratory quality assurance protocols include reference standards, assay calibration, quantitative controls, and standardized units of measure. The Magnani-Taylor editorial highlights their absence from IHC and urges their adoption. Without these enabling tools, different IHC labs can – and often do – return different results from the same sample.

“The higher proposed assay requirements will raise the quality of IHC testing to ensure accurate results, which will benefit pathologists, oncologists and, ultimately, patients,” said Dr. Steven Bogen, CEO, Boston Cell Standards. “However, aligning IHC laboratory testing globally requires that labs have access to enabling quality assurance tools that, until recently, were not available — calibration standards and image analysis quantification software to measure the calibrator test results.”

In light of these potential regulatory changes, Visiopharm and Boston Cell Standards are partnering to integrate IHC calibration standards with image analysis software for quality assurance. Boston Cell Standards pioneered the industry’s first calibration standards. Visiopharm developed Qualitopix™, a groundbreaking AI-driven image analysis software for IHC assay control quantification and tracking (Levey-Jennings analysis). Together, they represent the only commercial system capable of meeting the proposed higher assay regulatory requirements.

“We see an opportunity to integrate our category-defining technologies to drive the higher tier of laboratory performance the proposal seeks,” said Dr. Michael Grunkin, CEO, Visiopharm. “The combination of our two companies’ products represents a traditional instrument analyzer-reagent system. Qualitopix is the instrument and the calibrators/controls are the reagents.” The companies are planning to complete the initial integration and start clinical testing in 2023.

About Visiopharm

Visiopharm® is a leading provider of AI-driven precision pathology software for research and diagnostics. In research, it is a technology leader providing tools that help scientists, pathologists, and image analysis experts produce accurate data for all types of tissue-based research. In diagnostics, it is a leader within clinical applications, with no less than eight diagnostic algorithms cleared under IVDR for EU customers. These applications provide diagnostic decision support and and can be easily activated and integrated into existing lab workflows.

Founded in 2002, Visiopharm is privately owned and operates internationally with over 750 customer accounts in more than 40 countries. The company’s headquarters are located in Denmark’s Medicon Valley, with offices in Sweden, the UK, Germany, the Netherlands, and the United States, and local representation in France and China.

About Boston Cell Standards

Boston Cell Standards is the first and only company to develop and manufacture standardized reference materials for the immunohistochemistry industry. Its mission is to improve patient outcomes by ensuring that immunohistochemistry test results are accurate and reproducible regardless of where or when tests are performed. Laboratory reference materials are essential for that purpose.  For more information, please visit http://bostoncellstandards.com/.

Contact: 

Visiopharm:
Johanne Louise Brændgaard
Chief Marketing Officer
jlb@visiopharm.com

Boston Cell Standards:
Sam Choinski
Pazanga Health Communications
schoinski@pazangahealth.com

Visiopharm, a leading innovator in AI-driven Precision Pathology, acknowledges the significance of the recent editorial by Barbarajean Magnani and Clive R. Taylor published in Archives of Pathology and Laboratory Medicine, which calls for the regulation of clinical IHC as an assay rather than a stain. The authors highlight the need for more rigorous methods of analytic standardization, the importance of integrating pre-analytic, analytic, and post-analytic phases in a total test approach, and the necessity of a shift in mindset from viewing IHC as a stain to treating it as an assay. This is further supported by Dylan Miller in his editorial in the same journal, in which he points out that the CAP IHC resource committee is working to advance these principles, and that new formats and approaches are being explored for future survey.

We fully concur with the urgency of these points, which has also guided Visiopharm’s development of our AI-driven software tools, Qualitopix^TM and Oncotopix^®, over more than a decade. They are developed specifically to address many of these challenges, especially related to the evaluation of reproducibility of the analytical and post-analytical phases.

“The editorial by Magnani and Taylor underscores the critical need for improved quality assurance in IHC. Visiopharm’s development of Qualitopix, a state-of-the-art AI-based software solution that measures day-to-day staining consistency based on standardized and digitized control slides and provides Levey-Jennings plots for Class II IHC, is a significant step towards meeting the need outlined in the editorial”, stated Prof. Mogens Vyberg, Aalborg University, who is on the Scientific Advisory Board of Visiopharm.  The NordiQC IHC proficiency scheme was co-founded by Mogens Vyberg, the former director, and Søren Nielsen, the current director. NordiQC has contributed significantly to standardization of IHC by both the establishment of the proficiency scheme, but also by extended international scientific engagements and collaboration with other IHC stakeholders.

In addition, Oncotopix provides fully automated AI-based decision support for Class II IHC markers, such as ER, PR, HER2, Ki67 and PD-L1. Prof. Ralf Huss, University Hospital Augsburg, a recognized expert in pathology and Chairman of the Scientific Advisory Board of Visiopharm, comments, “Oncotopix’s ability to automate the analysis process and provide comprehensive reports on both the patient-specific analysis and the IHC control represents a major advancement in the field. This tool aligns with the vision expressed in the editorial and has the potential to significantly improve the accuracy and consistency of IHC results, reducing the risk of errors that could impact patient care. Also, such tools can help us avoid unnecessary re-testing and waste of precious material, as well as reduce costs and time in the conventional workflow to cope with limited human resources.”

“As the CEO of Visiopharm, I am proud of our team’s dedication to innovation and quality in the field of AI-driven Precision Pathology. We are committed to addressing the urgent needs that are expressed in the editorial and beyond. We believe that our AI-based tools, Qualitopix and Oncotopix, are essential for improving the quality and reliability of IHC testing, with quantitative quality control being the missing piece in modern biomarker assessment. Combining the precision with spatial information will enable Precision Pathology, and the beginning of a new era of precision oncology. We are very proud to collaborate on this vision with prominent organizations, such as NordiQC and UKNEQAS that both play instrumental roles in upholding standards in this field. Also, we are collaborating with leading providers of standardized and validated controls and calibrators that are used with Qualitopix, and, as pointed out in the editorial by Magnani and Taylor, these calibrators and controls required for day-to-day quality assurance exist already today”, stated Michael Grunkin.

For more information about Qualitopix and Oncotopix, please visit our website or contact our team.

About Visiopharm

Visiopharm® is a leading provider of AI-driven precision pathology software for research and diagnostics. In research, it is a technology leader providing tools that help scientists, pathologists, and image analysis experts produce accurate data for all types of tissue-based research. In diagnostics, it is a leader within clinical applications, with no less than eight diagnostic algorithms cleared under IVDR for EU customers. These applications provide diagnostic decision support and and can be easily activated and integrated into existing lab workflows.

Founded in 2002, Visiopharm is privately owned and operates internationally with over 750 customer accounts in more than 40 countries. The company’s headquarters are located in Denmark’s Medicon Valley, with offices in Sweden, the UK, Germany, the Netherlands, and the United States, and local representation in France and China.

Contact: 

Johanne Louise Brændgaard
Chief Marketing Officer
jlb@visiopharm.com