BOSTON– Ibex Medical Analytics has received certification under the European Union’s In Vitro Diagnostic Medical Devices Regulation for its artificial intelligence tools used to assess ER, PR and Ki67 biomarkers in breast cancer tissue.
The certification covers Ibex Breast ER, PR and Ki67 and completes regulatory approval for the company’s breast pathology portfolio across H&E, HER2, ER, PR and Ki67-stained whole-slide images.
Ibex said the certification followed clinical studies and a review of the products’ quality, safety and performance under European regulations.
The tools are part of Ibex 4, the company’s next-generation digital pathology platform, which provides a unified workspace for breast cancer diagnosis, immunohistochemistry workflow management and biomarker quantification.
The platform is designed to help pathologists analyze breast biopsies and excisions, automate portions of the diagnostic process and reduce reliance on fragmented manual workflows.
Ibex said its breast cancer suite includes scoring across the HER2 expression spectrum, including cell-level quantification intended to help identify HER2-low and HER2-ultralow cancers. Those classifications may be used to determine whether patients are eligible for targeted HER2-directed therapies.
Ibex Breast ER and PR provide automated quantification of estrogen receptor and progesterone receptor expression. The tools classify samples as positive, low-positive or negative based on 2020 guidelines from the American Society of Clinical Oncology and the College of American Pathologists.
The company’s Ki67 tool is designed to replace manual quantification with automated analysis intended to improve the accuracy and reproducibility of 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 Anne Vincent-Salomon, M.D., Ph.D., Pathologist at Institut Curie and 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% 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.”
Ibex said its AI system provides visual explanations of its findings and staining percentages to help pathologists review and interpret results.
“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, Chief Executive Officer of 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.”
The company is also working with laboratory information system and image management system providers to integrate its AI tools into pathology laboratories’ existing workflows.
