Ibex Medical Analytics, a leader in AI-powered cancer diagnostics, has announced that its HER2 biomarker scoring solution for breast cancer has received In Vitro Diagnostic Medical Devices Regulation (IVDR) certification in the European Union. The fully automated, “zero-click” AI tool is designed to assist pathologists in accurately and consistently scoring HER2 immunohistochemistry (IHC) results, including cases with low or ultralow expression levels. Developed in collaboration with AstraZeneca and Daiichi Sankyo, the solution analyzes digitized images of HER2 IHC-stained breast cancer tissue samples. It identifies tumor cell staining patterns and classifies HER2 expression according to the standardized ASCO/CAP guidelines into four categories: 0, 1+, 2+, and 3+. Notably, the AI system can detect and support the interpretation of HER2 ultralow cases—defined as IHC 0 with visible membrane staining—where accurate diagnosis is critical for treatment decisions. Clinical validation studies have demonstrated significant improvements in scoring accuracy and consistency among pathologists using the tool. These include a multi-center study involving 14 international cancer centers and a separate multi-reader validation study. The results highlight the system’s ability to perform reliably across diverse laboratory environments, including variations in scanners, anti-HER2 antibodies, and patient populations. The IVDR certification was granted after a rigorous evaluation process that assessed the product’s quality, safety, and performance. This milestone underscores the solution’s robustness and compliance with the EU’s stringent regulatory standards for medical devices. Dr. Elena Provenzano, lead breast histopathologist at Cambridge University Hospitals NHS Foundation Trust, emphasized the clinical value of the tool: “AI can be a valuable decision support tool, aiding pathologists to improve HER2 scoring accuracy and align more closely with expert breast pathologists, as well as enhancing consistency among pathologists, particularly in challenging cases at the lower end of the HER2 expression spectrum. Ibex’s HER2 tool could be extremely valuable in today’s clinical landscape, where there is increasing pressure to identify low-expressing HER2 cases in a more reproducible and objective manner.” The HER2 solution is part of Ibex Breast, an integrated AI platform that detects 54 tissue morphologies in routine breast H&E slides. This comprehensive workflow enables pathologists to analyze both H&E and IHC-stained slides with AI assistance, streamlining diagnosis, scoring, and reporting for breast biopsies and excisions. Dr. Manuela Vecsler, VP of Clinical and Scientific Affairs at Ibex Medical Analytics, said: “Our AI-powered solutions are designed with pathologists, for pathologists, enabling them to leverage cutting-edge technology to make more confident diagnoses. We are thrilled to see our HER2 IHC scoring solution’s high performance during IVDR clinical studies, with pathologists noting its ease of use, confidence boost, and smooth workflow integration—underscoring its real-world diagnostic impact. This certification reaffirms our commitment to providing the most accurate and reliable tools for pathologists, ultimately improving patient care.” Ibex Medical Analytics is a pioneer in clinical-grade AI for pathology, with its platform already adopted by leading pathology labs worldwide. The company’s solutions are CE-IVD certified and approved by regulatory bodies including the UK MHRA, TGA in Australia, and ANVISA in Brazil. In the United States, one solution is FDA-cleared, while others are available for research use only (RUO).