Vendor source
Reviewed 21 Jul 2026
Completeness Strong (75%)
Ki-67 APP, Breast Cancer
VisiopharmOur Ki-67 solution for breast cancer is fully automated and does not require manual input during analysis. The solution consists of four automated analysis steps. Once started, it automatically separates the sample tissue from control tissues and robustly identifies invasive cancer areas in the sample. Tumor nuclei are counted based on their Ki-67 expression and the resulting proliferation index for the whole tumor area is calculated.
Supported by 8 papers
Key features
Calculation of the proliferation index
Counting of all tumor cells
Counting of positively stained tumor cells
General Information
Product name
Company
Modality
Main task
Subspeciality
Organ/Specimen source
Not specified
Disease targeted
Specimen type
Staining
Stain subtype
Regulatory Information
Pathway:
In Vitro Diagnostic Regulation (IVDR)
Class:
Class C
Verified by Health AI Register
Scanner Brands Certified for Use (CE-IVD)
Scanner Models Certified for Use (CE-IVD)
Other certifications
Not specified
Evidence & Research
Peer-Reviewed Papers
Advancing Ki67 hotspot detection in breast cancer: a comparative analysis of automated digital image analysis algorithms
Histopathology · Aug 2024
Concordance between ER, PR, Ki67, and HER2‐low expression in breast cancer by MammaTyper RT‐qPCR and immunohistochemistry: implications for the practising pathologist
Histopathology · Apr 2024
Automated imaging analysis of Ki-67 immunohistochemistry on whole slide images of cell blocks from pancreatic neuroendocrine neoplasms
Journal of the American Society of Cytopathology · Feb 2024
A new tool for technical standardization of the Ki67 immunohistochemical assay
Modern Pathology · Feb 2021
<p>Digital Image Analysis of Ki-67 Stained Tissue Microarrays and Recurrence in Tamoxifen-Treated Breast Cancer Patients</p>
Clinical Epidemiology · Jul 2020
Automated assessment of Ki‐67 in breast cancer: the utility of digital image analysis using virtual triple staining and whole slide imaging
Histopathology · Jun 2020
Digital image analysis of Ki67 in hot spots is superior to both manual Ki67 and mitotic counts in breast cancer
Histopathology · Dec 2017
Digital image analysis outperforms manual biomarker assessment in breast cancer
Modern Pathology · Feb 2016
Technical Specifications
Patient population age
Not specified
Input
Input format
Output
Output format
Not specified
Integration
Deployment
Trigger for analysis
Processing time
Population
Viewer systems
Not specified
Market Presence
On market since
AI Platforms
Resellers
Countries present
Paying clinical customers
Not specified
Research/test users
Not specified
Pricing Information
Pricing model
Based on
Source: Vendor | First published: Jul 30, 2025 | Last updated: Jul 21, 2026