Ibex Medical Analytics (Ibex), a leader in artificial intelligence (AI)-powered cancer diagnostics, today announced it has received In Vitro Diagnostic Medical Devices Regulation (IVDR) certification for its HER2 breast cancer biomarker scoring solution. Ibex’s fully automated “zero-click” AI-enhanced decision support tool for pathologists efficiently increases the accuracy and consistency of HER2 immunohistochemistry (IHC) scoring, including HER2-low cases. Ibex’s breast HER2 solution was developed and validated by Ibex in collaboration with AstraZeneca and Daiichi Sankyo.
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Ibex's HER2 breast cancer biomarker scoring solution
Using digitized images of HER2 IHC stained breast cancer samples, Ibex’s breast HER2 solution detects invasive tumor cell staining patterns and classifies HER2 expression into four standard scores: 0, 1+, 2+ and 3+ (based on ASCO/CAP guidelines). It can assist pathologists in the detection and interpretation of cases with HER2 ultralow expression (defined as IHC 0 with membrane staining present). The AI-powered computational tool automates and optimizes case review with:
- “Zero-click” invasive tumor detection (automatically excluding ductal carcinoma in situ)
- Automated tumor cell identification and cell staining pattern classification
- Editable invasive contours and score recalculation
- Visualization of AI findings and cell staining pattern percentages for better understanding of score result
Pathologists supported by Ibex’s breast HER2 solution showed improvement in scoring accuracy and consistency, as demonstrated by two clinical studies; one spanning 14 international cancer centers and an additional multi-reader validation study.
The IVDR certificate was received following a meticulous review process, as required by EU regulations, reflecting trust in the quality, safety and performance of the product. Ibex’s breast HER2 solution has been shown to be exceptionally robust, with high performance across multiple labs, scanners, anti-HER2 antibodies, and patient demographics during IVDR clinical studies:
- Improved Accuracy (relative to experts): Pathologists supported by AI demonstrated improved sensitivity, when scoring HER2 0 and 1+ slides (91.2% manual score vs. 97.4% with AI) and overall accuracy for all HER2 scores (77.5% manual score vs. 86.6% with AI).
- Increased Consistency: Pathologists’ average inter-observer agreement was significantly higher when assisted by AI (94.1%) than with manual scoring (77.3%), in all slides, and specifically for HER2 0 and 1+ slides (97.2% with AI vs. 87.4% for manual score).
“AI can be a valuable decision support tool, aiding pathologists to improve HER2 scoring accuracy and align more closely with expert breast pathologists, as well as enhancing consistency among pathologists, particularly in challenging cases at the lower end of the HER2 expression spectrum,” says Dr. Elena Provenzano, lead breast histopathologist at Cambridge University Hospitals NHS Foundation Trust. “Ibex’s HER2 tool could be extremely valuable in today’s clinical landscape, where there is increasing pressure to identify low-expressing HER2 cases in a more reproducible and objective manner.”
Ibex’s HER2 biomarker solution is part of Ibex Breast, an integrated AI solution offering a streamlined diagnostic workflow that detects 54 tissue morphologies in breast H&E slides, which has been widely adopted by leading pathology labs worldwide.2,3 Pathologists can review H&E and IHC-stained slides with AI support, facilitating rapid, consistent and objective diagnosis, scoring, and reporting of breast biopsies and excisions.
“Our AI-powered solutions are designed with pathologists, for pathologists, enabling them to leverage cutting-edge technology to make more confident diagnoses,” remarked Dr. Manuela Vecsler, VP of Clinical and Scientific Affairs at Ibex Medical Analytics. “We are thrilled to see our HER2 IHC scoring solution’s high performance during IVDR clinical studies, with pathologists noting its ease of use, confidence boost, and smooth workflow integration—underscoring its real-world diagnostic impact. This certification reaffirms our commitment to providing the most accurate and reliable tools for pathologists, ultimately improving patient care.”
About Ibex Medical Analytics
Ibex Medical Analytics is transforming cancer diagnostics with world-leading clinical grade AI-powered solutions for pathology. Empowering physicians and supporting pathologists, Ibex is on a mission to provide accurate, timely and personalized cancer diagnosis for every patient. Ibex is the first and most widely deployed AI-powered platform in pathology. Pathologists worldwide use Ibex as part of their everyday routine to improve the accuracy of cancer diagnosis, implement comprehensive quality control measures, reduce turnaround times, and boost productivity with more efficient workflows.
The Ibex platform includes solutions that are CE-IVD certified and registered with the UK MHRA, TGA in Australia and ANVISA in Brazil. It includes a solution that is FDA cleared and others that are Research Use Only (RUO) in the United States.
References:
- Krishnamurthy et al. Clin Cancer Res (2025), 31 (12_S): P1-07-03.
- Sandbank et al. npj Breast Cancer (2022), 8:129.https://doi.org/10.1038/s41523-022-00496-w
- Broeckx et al. Virchows Arch (2023) 483 (Suppl 1): S36
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“Ibex’s HER2 tool could be extremely valuable in today’s clinical landscape, where there is increasing pressure to identify low-expressing HER2 cases in a more reproducible and objective manner.”
