The clinical validation and regulatory certification of Ibex's breast IHC workflow is expected to further boost pathology lab performance and enhance patient care
BOSTON & TEL AVIV, Israel--(BUSINESS WIRE)--Ibex Medical Analytics (Ibex), the global leader in AI-powered pathology solutions for clinical diagnostics and biopharma, today announced that it has received In Vitro Diagnostic Medical Devices Regulation (IVDR) certification for Ibex Breast ER, PR and Ki67. This milestone solidifies Ibex’s position as the market leader in breast cancer diagnostics by rounding out regulatory approval for its entire breast portfolio, which delivers unprecedented value to pathologists, laboratories, and patients. Covering biopsies and excisions, the breast suite comprises a fully IDVR-certified, end-to-end workflow across H&E, HER2, ER, PR, and Ki67-stained whole slide images. This was achieved following clinical studies and a meticulous review process, as required by EU regulations, reflecting trust in the quality, safety and performance of the product.
One Integrated Breast AI Solution
As breast cancer volumes rise and the emergence of new targeted therapies and personalized medicine necessitates more complex diagnostic testing, patients rely on pathologists having access to complete, AI-supported workflows rather than fragmented, manual solutions. Ibex 4, the next-generation platform, provides a unified workspace that seamlessly transitions from automated breast primary diagnosis1-4 to IHC workflow optimization5 and complex IHC quantification for HER26, ER8, PR8 and Ki678. To ensure comprehensive support for modern precision oncology, the suite provides complete scoring capabilities across the full HER2 expression spectrum. This includes accurate cell-level quantification, enabling pathologists to identify HER2-low and HER2-ultralow breast cancers, ensuring laboratories can confidently identify patients eligible for targeted HER2-directed therapies.
Ibex Breast ER, PR and Ki67 - Standardizing Quantification
Ibex Breast ER and PR deliver automated ER and PR quantification, delineating expression into positive/low-positive and negative based on ASCO/CAP 2020 guidelines9, and ensuring every patient is accurately identified for optimal endocrine therapy. Ibex Breast Ki67 aligns with the International Ki67 Working Group10 and St. Gallen expert consensus11, and replaces manual quantification with AI-powered precision for accurate, reproducible patient stratification.
"The addition of CE-IVDR certification for ER, PR, and Ki67 completes a crucial piece of the puzzle for digital pathology laboratories," said Prof. Anne Vincent-Salomon, pathologist at Institut Curie, Director of the Women's Cancer Institute co-founded by Institut Curie, Inserm and PSL. "Our multi-center study demonstrated that Ibex’s “zero-click” IHC quantification significantly improves scoring precision and consistency. For Ki67, the interobserver agreement improved by 10% when using the AI, while accuracy reached 94%8 compared to the reference expert score. By providing explainable visualizations of AI findings and clear staining percentages, Ibex builds immense clinician confidence and delivers the standardization essential for modern precision medicine."
"With the full breast suite now IVDR certified, we are delivering on our promise to provide a truly comprehensive diagnostic support platform for breast pathology," said Yair Heller, CEO at Ibex Medical Analytics. "Ibex 4 is designed to transform the diagnostic journey and we look forward to continually expanding our breast AI pipeline to address even more critical laboratory workflows.” By integrating clinical-grade AI into the diagnostic pathway, Ibex is directly driving improvements in patient care, ensuring more accurate, reproducible, and timely diagnoses. The end-to-end breast suite allows pathologists to "see more and click less." Recognizing the importance of seamless lab workflows, Ibex continues to partner with industry leaders on LIS and IMS integrations that make it easier than ever for pathologists to incorporate AI technology into daily practice.
For more information on the complete Ibex Breast Solution, please visit https://ibex-ai.com/breast/.
About Ibex Medical Analytics
Ibex is the global leader in clinical-grade AI for pathology, with hundreds of clinically deployed solutions and partnerships spanning top pharmaceutical organizations, life-science companies, reference laboratories, and digital pathology vendors. Ibex collaborates with leading biopharma teams to accelerate biomarker development and commercialization using AI-powered IHC scoring algorithms and our existing commercial network, backed by an ISO 13485-compliant QMS.
Ibex Breast is IVDR certified and includes the Ibex platform solutions for Breast H&E (biopsies and excisions) and Breast IHC (HER2, ER, PR, Ki67). The Ibex platform includes solutions that are CE-IVD certified and registered with MHRA in the UK, TGA in Australia, ANVISA in Brazil, AMAR in Israel & Swissmedic in Switzerland. It includes a solution that is FDA cleared and others that are RUO in the United States.
For additional company information, please visit https://ibex-ai.com/ and follow us on LinkedIn and X.
- Tahir et al. Clin Breast Cancer. 2025
- Sandbank et al. NPJ Breast Cancer 2022
- Vecsler et al. Virchows Arch. 2025 Sep;487(Suppl 1):PS-01-038
- Canas-Marques et al. Virchows Arch. 2025 Sep;487(Suppl 1):OFP-05-007.
- Deman et al. (2026), Histopathology, https://doi.org/10.1111/his.70181
- Vecsler et al. Presented at SABCS 2025
- Vincent-Salomon et al. Presented at USCAP 2026.
- Allison et al. ASCO/CAP Guideline Update. JCO (2020) 38: 1346-1366.
- Updated Recommendations From the International Ki67 in Breast Cancer Working Group. J Natl Cancer Inst. 2021 Jul 1;113(7):808-819.
- St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2021
Contacts
Tamar Brosh, VP Marketing, tamar.brosh@ibex-ai.com
