Reviewed 9 Jun 2026

Completeness Fair (31%)

PCK VDS, Tumor Detection

Visiopharm

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

PCK VDS, Tumor Detection

Company

Modality

Histopathology

Main task

Detection, Scoring (IHC quantification), Segmentation

Subspeciality

Breast pathology

Organ/Specimen source

Not specified

Disease targeted

Breast cancer

Specimen type

Not specified

Staining

IHC

Stain subtype

ER, KI-67, PCK, PR

Regulatory Information

CE-IVD Certification

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)

Not specified

Other certifications

Not specified

Evidence & Research

No research papers or evidence on file yet.

The registry monitors publications for new evidence.

Technical Specifications

Patient population age

Not specified

Input

Not specified

Input format

Not specified

Output

The output consists of one or more ROIs, outlining the tumor areas. The output variable obtained from this protocol is tumor area: The total area of the tumor regions measured in [µm²].

Output format

Not specified

Integration

Not specified

Deployment

Not specified

Trigger for analysis

Not specified

Processing time

Not specified

Population

Not specified

Viewer systems

Not specified

Market Presence

On market since

Not specified

AI Platforms

Resellers

Not specified

Countries present

Not specified

Paying clinical customers

Not specified

Research/test users

Not specified

Pricing Information

Pricing model

Subscription

Based on

Not specified

First published: Jul 30, 2025 | Last updated: Jun 9, 2026