Press Releases | March 19, 2024 |

Transforming Diagnostic Consistency: Visiopharm Joins Forces with UK NEQAS ICC & ISH to Advance IHC Testing and Patient Outcomes 

In a groundbreaking collaboration, Visiopharm and the UK National External Quality Assessment Scheme for Immunocytochemistry and In-Situ Hybridisation (UK NEQAS ICC & ISH) are setting new standards in the quality control of IHC testing, harnessing cutting-edge AI technology alongside rigorous external quality assessment.

The need for this initiative is clearly demonstrated in the highly concerning data that reveal 25-30% of laboratories repeatedly fail to meet minimum proficiency standards when testing for critical predictive biomarkers, most often due to false negative results. Given that these tests significantly influence patient treatment decisions, the implications of such inaccuracies are profound.

The alliance introduces a comprehensive toolkit for pathology laboratories, designed to maintain staining quality and align with the latest clinical and regulatory requirements. Visiopharm’s innovative Qualitopix solution enables daily and continuous measuring, monitoring, and documentation of staining consistency/quality, promptly identifying and addressing any deviations. When coupled with UK NEQAS ICC & ISH’s rigorous four-monthly assessments, the laboratory is assured of end-to-end quality assurance monitoring.

Mr. Andy Dodson, Director of UK NEQAS ICC & ISH, highlighted the gravity of the current situation: “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.

This initiative is poised to redefine industry benchmarks, facilitating laboratories’ adherence to the stringent requirements of the recently revised ISO15189:2022 standard and other regulatory mandates, thereby ensuring superior patient care.

Dr. Michael Grunkin, CEO of Visiopharm, stressed the initiative’s ultimate goal: “At the heart of our mission is patient care. Through this collaboration, we are committed to providing laboratories with the advanced tools necessary for enhancing diagnostic precision. Our joint efforts are expected to play a pivotal role in ensuring patients receive the most effective treatments available.

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 nine 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 legal entities in Sweden, the UK, Germany, the Netherlands, and the United States, and local representation in France and China.

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UK NEQAS ICC & ISH is at the forefront of external quality assessment for advanced diagnostic testing in cellular pathology, committed to elevating the standards of IHC and ISH biomarker testing and ensuring adherence to the highest quality and regulatory standards. Founded in 1986, it was one of the first to introduce external quality assessment into clinical cellular pathology. The Scheme is fully accredited to ISO/IEC standards both in the UK and internationally. It operates worldwide, providing a fully comprehensive EQA service to clinical laboratories in more than 50 countries.

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