Boston and Tel Aviv, Israel, July 23, 2026
Ibex Medical Analytics announced it has received CE-IVDR certification for Ibex Breast ER, PR, and Ki67, completing regulatory approval for its comprehensive AI-powered breast cancer diagnostic portfolio. The certification establishes the company’s breast solution as a fully IVDR-certified end-to-end digital pathology workflow, supporting breast biopsies and excisions across H&E, HER2, ER, PR, and Ki67-stained whole slide images. The milestone follows extensive clinical validation studies and a rigorous regulatory review demonstrating the product’s quality, safety, and diagnostic performance under the European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR). The newly certified workflow is designed to help pathology laboratories improve diagnostic accuracy, workflow efficiency, and consistency while supporting the growing demand for precision oncology and personalized breast cancer treatment.
AI Platform Delivers Comprehensive Breast Cancer Diagnostic Support
The next-generation Ibex 4 platform provides a unified artificial intelligence workspace that integrates primary breast cancer diagnosis, immunohistochemistry (IHC) workflow optimization, and automated quantification of key biomarkers including HER2, ER, PR, and Ki67. The platform enables pathologists to perform highly accurate cell-level biomarker analysis, supporting identification of HER2-positive, HER2-low, and HER2-ultralow breast cancers, which play an increasingly important role in selecting patients for targeted HER2-directed therapies. By replacing fragmented manual workflows with an integrated AI-assisted diagnostic system, the platform aims to improve laboratory productivity while ensuring greater consistency in pathology reporting. The complete solution also supports the expanding role of personalized medicine by enabling more reliable biomarker evaluation for treatment decision-making.
Automated Quantification Improves Accuracy and Standardization
The newly certified Ibex Breast ER and PR applications automatically quantify hormone receptor expression and classify results according to ASCO/CAP 2020 clinical guidelines, ensuring accurate identification of patients eligible for endocrine therapy. Meanwhile, Ibex Breast Ki67 follows recommendations established by the International Ki67 Working Group and the St. Gallen Expert Consensus, replacing labor-intensive manual scoring with standardized AI-powered quantification. According to clinical validation studies, the technology significantly improved diagnostic consistency among pathologists, with interobserver agreement increasing by approximately 10% for Ki67 assessment and overall scoring accuracy reaching 94% when compared with expert reference evaluations. The system also provides explainable visual outputs and clear biomarker staining percentages, allowing pathologists to verify AI-generated findings while increasing confidence in diagnostic decisions.
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Certification Strengthens Global AI Pathology Leadership
With the addition of CE-IVDR certification for ER, PR, and Ki67, Ibex Medical Analytics now offers one of the industry’s most comprehensive AI-powered breast pathology solutions available for routine clinical practice. The company continues expanding its digital pathology ecosystem through partnerships that integrate its platform with Laboratory Information Systems (LIS) and Image Management Systems (IMS), enabling seamless adoption within pathology laboratories. Beyond Europe, the Ibex platform also holds multiple international regulatory approvals, including FDA clearance for selected products in the United States as well as certifications in the United Kingdom, Australia, Brazil, Israel, and Switzerland. By combining clinically validated artificial intelligence with regulatory-approved diagnostic workflows, Ibex Medical Analytics continues advancing the use of AI-driven pathology to improve diagnostic precision, laboratory efficiency, and patient care in breast cancer diagnostics.
Source: Ibex Medical Analytics press release
