Table 4.
Summary of commercially available AI algorithms for breast cancer pathology
| Platform/algorithm | Vendor | Indication | Certified/approved by | HE slides/IHC slides | Image requirement (scanner, magnification) | Workflow requirement if any | Supported samples | Output | Publications/data |
|---|---|---|---|---|---|---|---|---|---|
| Mindpeak Breast HER2 RoI | Mindpeak | breast cancer | CE-IVD | IHC slides | WSI scanner | interactive image viewer software | anti-HER2/neu clone 4B5 assay from Ventana, EP3 from Cell Marque and HercepTest (sometimes referred to as clone A0485) from Agilent Dako | HER2 score | https://uploads-ssl.webflow.com/60424989e8e0f02a922616f9/631072d2e19725a967c1735f_Mindpeak%20Breast%20HER2%20RoI%20-%20Clinical%20performance%20evaluation%20summary%20-%20APPROVED.pdf |
| Mindpeak Breast Ki-67 HS | Mindpeak | breast cancer | CE-IVD | IHC slides | WSI scanner | interactive image viewer software | MIB-1 pharmDx assay from Agilent Dako and the 30–9 antibody assay from Roche Diagnostics | Ki-67 score | https://uploads-ssl.webflow.com/60424989e8e0f02a922616f9/6317189c812a662bd8aa3055_Mindpeak%20Breast%20Ki-67%20HS%20-%20Clinical%20performance%20evaluation%20summary.pdf |
| Mindpeak Breast ER/PR | Mindpeak | breast cancer | CE-IVD | IHC slides | WSI scanner | interactive image viewer software | SP1 assay from Roche Ventana and the EP1 assay from Agilent Dako, as well as for PR through the clone 16 assay from Leica Biosystems, the clone 1E2 assay from Roche Ventana and the clone 1294 assay from Agilent Dako | ER/PR assessment | https://uploads-ssl.webflow.com/60424989e8e0f02a922616f9/631718ea00a1495c8a8dfa3b_Mindpeak%20Breast%20ER_PR%20-%20Clinical%20performance%20evaluation%20summary.pdf |
| Mindpeak Breast Metastasis Detection | Mindpeak | suspicious cases with breast cancer metastasis | N/A | H&E slides | N/A | Standard personal working machine. Minimum requirements: 32 bit Processor Intel Core i5 or better; 4 GB RAM | N/A | Segmentation of tissue into cancerous and benign areas | https://www.mindpeak.ai/products/mindpeak-metastasis-detection#:~:text=Mindpeaks%20Breast%20Metastasis%20Detection%20supports,metastases%20associated%20with%20breast%20adenocarcinoma |
| OWKIN RlapsRisk™ BC | Mindpeak | ER + /HER2- invasive carcinoma of the breast | N/A | H&E slides | WSI scanner | IMS systems or even a shared directory | N/A | determinatin the best treatement for high risk patient of early breast cancer | Garberis IJ, Gaury V, Drubay D, et al. Blind validation of an AI-based tool for predicting distant relapse from breast cancer HES stained slides. Poster presented at: European Society for Medical Oncology (ESMO); May 9th—13th 2022; Paris France |
| Visiopharm ER, PR, Ki-67 APP | Visiopharm | breast cancer | CE-IVD | IHC slides | WSI scanner | IMS system | staining from Agilent, Roche or Leica | ER assessment | https://visiopharm.com/app-center/app/ki-67-breast-cancer/ |
| Visiopharm: Invasive Tumor Detection (PDS) | Visiopharm | breast cancer | CE-IVD | IHC slides | WSI scanner | N/A | p63: Roche Ventana/Zeta, CK7:Dako, CK19: AH-diagnostics/Cell Marque/Roche Ventana, combined with any biomarker APP using VirtualTripleStaining (VTS) | Automatic detection of invasive tumor | https://visiopharm.com/app-center/app/invasive-tumor-detection-vds/ |
| Visiopharm HER2-CONNECT™ | Visiopharm | breast cancer | CE-IVD | IHC slides | WSI scanner | N/A | NordiQC HER2 biomarker | HER2 scoring | https://visiopharm.com/app-center/app/her2-breast-cancer/ |
| Visiopharm – lymph node metastasis | Visiopharm | Breast &colorectal cancer | CE-IVD | H&E slides | WSI scanner | N/A | N/A | lymph nodes metastasis detection | https://visiopharm.com/ai-assisted-metastasis-detection-in-lymph-nodes/ |
| Visiopharm: HER2-S(D)ISH | Visiopharm | breast cancer | N/A | Immunofluroscence slides | WSI scanner | N/A | INFORM™ HER2 Dual ISH assay from Ventana/Roche | HER2-SISH assessment | https://visiopharm.com/app-center/app/her2-sish-breast-cancer/#:~:text=The%20Human%20Epidermal%20Growth%20Factor,response%20to%20HER2%2Dtargeted%20treatment |
| Visiopharm: HER2-FISH | Visiopharm | breast cancer | N/A | Immunofluroscence slides | WSI scanner | N/A | N/A | HER2-FISH assessment | https://visiopharm.com/app-center/app/her2-fish-breast-cancer/#:~:text=The%20Human%20Epidermal%20Growth%20Factor,response%20to%20HER2%2Dtargeted%20treatment |
| PathAI: AIM-HER2 | PAthAI | Breast cancer | N/A | IHC slides | Leica Aperio® AT2 and GT450; Hamamatsu NanoZoomer® s360 | N/A | Ventana 4B5 and Dako HercepTest™ | HER2 score, Area of invasive carcinoma; Additive multiple instance learning (aMIL) density heatmap | https://pathaiwp.wpenginepowered.com/wp-content/uploads/2023/01/Copy-of-ESMO_PathAI_DS_BG_FINAL.pdf |
| Paige Breast Suite | Paige | Breast cancer | CE-IVD and UKCA | H&E slides | Leica Aperio AT2 and GT450 Scanners | clinical-grade viewer, FullFocus | N/A | detection of premalignant and malignant neoplasms | https://paige.ai/clinical/# |
| Paige Breast Lymph Node | Paige | Breast cancer | CE-IVD and UKCA | H&E slides | Leica Aperio AT2 and GT450 Scanners | clinical-grade viewer, FullFocus | N/A | lymph nodes metastasis detection | https://paige.ai/clinical/# |
| IBEX GALEN™ BREAST: AI-powered Pathology | IBEX | Breast cancer | CE-IVD | H&E slides | WSI scannrer | slide viewer | N/A | subtype detection&grading | https://ibex-ai.com/wp-content/uploads/2022/12/Sandbank_et_al-2022-npj_Breast_Cancer.pdf |