IBEX
BREAST HER2
AI-powered Pathology
Transforming Cancer Diagnosis
- Fully automated “zero-click” AI-powered decision support tool for pathologists scoring HER2 immunohistochemistry (IHC)
- Delineates HER2 expression into four standard scores: 0, 1+, 2+ and 3+, based on the 2023 ASCO/CAP guidelines1
- Increases accuracy and reproducibility of HER2 IHC scoring, including the highly subjective HER2-low cases2, 3, 4
- The AI-powered computational pipeline automates and optimizes case review:
- “Zero-click” invasive tumor detection (automatically excluding DCIS)
- Automated tumor cell identification and staining pattern classification
- Scoring explainability with visualization of AI findings and staining pattern percentages
Image: Scored HER2 1+ after AI found 17% faint staining and 1.6% moderate (complete and incomplete) staining
HER2: Prognostic and Predictive
Human epidermal growth factor receptor 2 (HER2), one of the proteins responsible for division and proliferation of breast cancer cells, is overexpressed in many breast tumors. Its accurate assessment is critical for identifying patients who are likely to benefit from HER2-directed therapies.
Enhertu (trastuzumab deruxtecan) was recently approved by the US FDA and EU EMA for patients with HER2-low metastatic breast cancer (HER2 IHC 1+ or 2+ / ISH-)5,6; it has also demonstrated clinical efficacy for HER2-ultra-low patients.7 This amplifies the need for more accurate and reproducible scoring of HER2 expression, which may be supported by AI-powered solutions that are particularly useful for HER2-low identification.
Ibex Breast HER2, an AI-powered decision support tool for pathologists, increases the precision and consistency of HER2 IHC scoring, including the highly subjective HER2-low cases, thereby enabling optimized treatment pathways and improved patient outcomes.2
Ibex Breast HER2 is part of Ibex Breast, an integrated AI solution offering a streamlined diagnostic workflow.8,9 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. Ibex Breast has built-in configurable reporting for H&E and IHC slides (including HER2, ER, PR and Ki-67).
AI solutions for ER, PR and Ki-67 coming soon
Clinically Proven Excellence
Pathologists supported by Ibex Breast HER2 showed improvement in scoring accuracy and consistency, as demonstrated by an early evidence program spanning 14 international cancer centers and laboratories and a multi-reader validation study. The AI is exceptionally robust, with high performance across multiple labs, scanners and patient demographics.2,3,4
100% of pathologists report they feel more confident about their scoring accuracy when assisted by Ibex Breast HER2 and find it useful in their clinical practice.2
Improved Accuracy
Agreement with ground truth
Increased Consistency
Inter-observer concordance
The Ibex platform includes solutions that are CE-IVD cleared and registered with the UK MHRA, TGA in Australia and ANVISA in Brazil. It is for Research Use Only (RUO) in the United States and pending FDA clearance. For additional details please approach Ibex.
1. Wolff AC, et al. Arch Pathol Lab Med. 2023 Sep 1;147(9):993-1000; 2. Cyrta et al. ESMO Open (2024), 9; 54: 103071; 3. Krishnamurthy et al. JCO 42, e15150-e15150(2024); 4. Krishnamurthy et al. Virchows Arch (2023) 483 (Suppl 1): S35; 5. Modi et al. NEJM, 2022; 387:9; 6. Mosele et al. Nat Med 2023; 29, 2110–2120; 7. Curigliano et al. JCO, 2024. 42(LBA1000-LBA1000); 8. Sandbank et al. npj Breast Cancer (2022), 8:129. https://doi.org/10.1038/s41523-022-00496-w; 9. Broeckx et al. Virchows Arch (2023) 483 (Suppl 1): S36