Ibex Medical Analytics, a leader in AI-powered cancer diagnostics, has announced it has received In Vitro Diagnostic Medical Devices Regulation (IVDR) certification for its HER2 breast cancer biomarker scoring solution. This milestone marks a significant advancement in digital pathology, enabling the company’s fully automated “zero-click” AI tool to support pathologists in accurately and consistently scoring HER2 immunohistochemistry (IHC) results, including challenging cases of HER2-low and ultralow expression. The AI solution analyzes digitized images of HER2 IHC-stained breast cancer tissue samples, detecting tumor cell staining patterns and classifying HER2 expression levels into the standard four categories: 0, 1+, 2+, and 3+ according to ASCO/CAP guidelines. It is particularly effective in identifying cases with HER2 ultralow expression—defined as IHC 0 with visible membrane staining—which are often difficult to interpret and can impact treatment decisions for patients eligible for targeted therapies. Developed in collaboration with pharmaceutical giants AstraZeneca and Daiichi Sankyo, the tool has been validated through rigorous clinical studies. Results from a multi-center trial involving 14 international cancer centers and a separate multi-reader validation study demonstrated that pathologists using Ibex’s solution achieved significantly improved scoring accuracy and consistency, especially in borderline or low-expression cases. The IVDR certification reflects a thorough regulatory review, underscoring the solution’s reliability, safety, and performance across diverse clinical settings. The system has proven robust across different laboratories, digital slide scanners, anti-HER2 antibodies, and patient populations, ensuring consistent results regardless of technical or biological variability. 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.” She added that the tool is especially relevant in today’s clinical landscape, where identifying low-expressing HER2 cases is increasingly critical for expanding treatment options. The HER2 solution is part of Ibex Breast, an integrated AI platform that detects 54 tissue morphologies in breast hematoxylin and eosin (H&E) slides. This comprehensive system streamlines the diagnostic workflow by enabling pathologists to review both H&E and IHC-stained slides with AI assistance, supporting faster, more objective, and standardized diagnosis, scoring, and reporting of breast biopsies and excisions. Dr. Manuela Vecsler, VP of Clinical and Scientific Affairs at Ibex, highlighted the user-centered design of the platform: “Our AI-powered solutions are designed with pathologists, for pathologists, enabling them to leverage cutting-edge technology to make more confident diagnoses.” She noted that pathologists have reported increased confidence, ease of use, and seamless integration into existing workflows. Ibex Medical Analytics is the first and most widely deployed AI platform in pathology, trusted by leading labs worldwide. Its solutions are CE-IVD certified and registered with regulatory bodies in the UK, Australia, and Brazil, with one solution FDA-cleared and others available for research use in the United States. With this IVDR certification, Ibex reinforces its mission to deliver accurate, timely, and personalized cancer diagnostics, ultimately improving patient outcomes through smarter, more reliable pathology workflows.