Reviewed 9 Jun 2026
Completeness Fair (31%)
Developed for tumor detection in PCK stained breast tissue
This APP has been developed to improve quantification of ER, PR or Ki-67 positive cells within breast carcinoma, by automatically identifying tumor areas. The APP uses the Virtual Double Staining (VDS) technique, which enables automated and robust detection of tumor regions.
Two serial sections stained for ER/PR/Ki-67 and Pancytokeratin (PCK), respectively, must be used in this APP. Tumor regions are identified automatically on the PCK stained slides and the outlined tumor region are overlaid on the biomarker stained slide, thus automatically outlining the tumor regions in the other stain.
No papers to support — we monitor for new evidence.
General Information
Product name
Company
Modality
Main task
Subspeciality
Organ/Specimen source
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Disease targeted
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Staining
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Regulatory Information
Pathway:
In Vitro Diagnostic Regulation (IVDR)
Class:
Class C
Not verified by Health AI Register
Scanner Brands Certified for Use (CE-IVD)
Not specified
Scanner Models Certified for Use (CE-IVD)
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Other certifications
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Evidence & Research
No research papers or evidence on file yet.
The registry monitors publications for new evidence.
Technical Specifications
Patient population age
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Input
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Output
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Integration
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Deployment
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Population
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Viewer systems
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Market Presence
On market since
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AI Platforms
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Countries present
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Paying clinical customers
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Research/test users
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Pricing Information
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Based on
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First published: Jul 30, 2025 | Last updated: Jun 9, 2026