AI Digital Pathology Platform Standardizes IHC Scoring in Breast Cancer

As rising case volumes and expanding therapeutic indications place greater demands on pathology services and information systems, a newly certified digital pathology suite now standardizes estrogen receptor (ER), progesterone receptor (PR), Ki67, and other assessments within an integrated artificial intelligence (AI) environment, offering end-to-end decision support for breast pathology.

Ibex Medical Analytics has received In Vitro Diagnostic Medical Devices Regulation (IVDR) certification in the European Union for Ibex Breast ER, PR, and Ki67, extending regulatory coverage across its breast portfolio and supporting use on biopsies and excisions. The suite operates within Ibex 4, a next-generation platform that unifies primary diagnosis, immunohistochemistry (IHC) workflow optimization, and quantitative analysis across hematoxylin and eosin (H&E), human epidermal growth factor receptor 2 (HER2), ER, PR, and Ki67 whole-slide images. According to the company, certification followed clinical studies and a regulatory review process conducted under EU requirements.

The technology provides cell-level quantification and complete scoring across the full HER2 expression spectrum, including identification of HER2-low and HER2-ultralow breast cancers. For hormone receptor testing, the ER and PR applications classify expression into positive/low-positive and negative categories aligned with 2020 ASCO/CAP guidelines. The Ki67 application aligns with the International Ki67 Working Group and St. Gallen expert consensus, replacing manual counts with automated, reproducible output. 

The platform also includes solutions with CE-IVD status and registrations with regulators in the UK, Australia, Brazil, Israel, and Switzerland. In the United States, it includes an FDA-cleared solution and other applications designated for research use only. Integrations with laboratory information systems (LIS) and image management systems (IMS) are available to streamline adoption.

“The addition of CE-IVDR certification for ER, PR, and Ki67 completes a crucial piece of the puzzle for digital pathology laboratories. 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% 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,” said Prof. Anne Vincent-Salomon, pathologist at Institut Curie and Director of the Women’s Cancer Institute co-founded by Institut Curie, Inserm and PSL.

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