The certification covers estrogen receptor, progesterone receptor, and Ki67 tests, completing the company’s breast cancer portfolio.
Ibex Medical Analytics has received In Vitro Diagnostic Medical Devices Regulation (IVDR) certification for its breast cancer diagnostic tools, according to a press release from the company. The certification covers Ibex Breast ER, PR, and Ki67, which completes regulatory approval for the company’s breast portfolio for biopsies and excisions.
The suite includes a workflow across hematoxylin and eosin, human epidermal growth factor receptor 2 (HER2), estrogen receptor (ER), progesterone receptor (PR), and Ki67-stained whole slide images. The Ibex 4 platform provides a unified workspace for primary diagnosis, immunohistochemistry (IHC) workflow optimization, and IHC quantification, according to a company release.
The suite provides scoring capabilities across the HER2 expression spectrum, including cell-level quantification to help pathologists identify HER2-low and HER2-ultralow breast cancers, the company says in a release. This identification helps laboratories determine which patients are eligible for targeted HER2-directed therapies.
Ibex Breast ER and PR provide automated ER and PR quantification based on American Society of Clinical Oncology and College of American Pathologists 2020 guidelines, according to the company. Ibex Breast Ki67 aligns with the International Ki67 Working Group and St. Gallen expert consensus, replacing manual quantification with artificial intelligence-powered precision for patient stratification, the company says in a release.
A multi-center study demonstrated that the IHC quantification improves scoring precision and consistency, says Anne Vincent-Salomon, MD, PhD, pathologist at Institut Curie and director of the Women’s Cancer Institute, in a release. For Ki67, the interobserver agreement improved by 10% when using the software, while accuracy reached 94% compared to the reference expert score, Vincent-Salomon says in a release.
“The addition of CE-IVDR certification for ER, PR, and Ki67 completes a crucial piece of the puzzle for digital pathology laboratories,” says Vincent-Salomon in a release. “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.”
The certification follows clinical studies and a review process required by European Union regulations.
“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,” says Yair Heller, CEO at Ibex Medical Analytics, in a release. Heller says the platform is “designed to transform the diagnostic journey” and the company plans to expand its pipeline to address more laboratory workflows.
Ibex continues to partner with industry leaders on laboratory information system and image management system integrations to help pathologists incorporate the technology into daily practice, the company says in a release.
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