Visiopharm and Boston Cell Standards Announce Partnership to Develop Joint IHC Technology for Magnani-Taylor Regulatory Proposal

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 and UK customers. These applications provide diagnostic decision support 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/.