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ProductsMindpeak Breast HER2 RoI

Reviewed 9 Jun 2026

Completeness Strong (64%)

Mindpeak Breast HER2 RoI

Mindpeak GmbH

Mindpeak Breast HER2 RoI is a software for automated image analysis of digital histopathology images of human invasive mamma carcinoma tissue samples.

Image analysis consists of the detection and classification of IHC stained tumor cells within predefined regions of interest (ROI).

A HER2 score is provided based on the distribution of classified tumor cells within the regions of interest according to the latest clinical practice guideline (ASCO/CAP 2018): IHC 0 or 1+ (HER2 negative), IHC 2+ (equivocal/borderline) or IHC 3+ (HER2 positive).

No papers to support — we monitor for new evidence.

Mindpeak Breast HER2 RoI
Mindpeak Breast HER2 RoI
Mindpeak Breast HER2 RoI
Mindpeak Breast HER2 RoI
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Key Features

  • Cancer detection
  • Cell classification
  • HER2 score
  • Tissue segmentation

General Information

Product name

Mindpeak Breast HER2 RoI

Modality

Histopathology

Main task

Scoring (IHC quantification)

Subspeciality

Breast pathology

Organ/Specimen source

Not specified

Disease targeted

Breast cancer

Specimen type

Not specified

Staining

IHC

Stain subtype

HER2

Regulatory Information

CE-IVD Certification

Pathway:

In Vitro Diagnostic Directive (IVDD)

Class:

General IVD Devices

Verified by Health AI Register

Scanner Brands Certified for Use (CE-IVD)

Roche, Phillips, 3DHistech, Hamamatsu, Leica

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

whole slide image, 0.5 µm/pixel, ER or PR IHC staining

Input format

BIF, MRXS, NDPI, Others, SVS, TIFF

Output

Cell classification, Image Annotations, Clinical Score, Cell Count

Output format

JSON

Integration

Integration via AI marketplace or distribution platform, Integration with hospital reporting system, Integration with IMS (Image Management System), Integration with LMS (Laboratory Management System)

Deployment

Cloud-based, Hybrid, Locally on dedicated hardware, Locally virtualized (virtual machine, docker)

Trigger for analysis

Automatically, Image upload, On demand, Right after the image acquisition, Triggered by a user through e.g. a button click

Processing time

1 - 10 minutes

Population

Not intended to be used for non-cancer breast tissue, necrotic tissue, ductal carcinoma in situ (DCIS) only lesions, inflammatory breast cancer (IBC), angiosarcoma of the breast, Paget disease of the breast, special type carcinoma other than ILC, adenoid cystic carcinoma, low-grade adenosquamous carcinoma, medullary carcinoma, mucinous (or colloid) carcinoma, papillary carcinoma, tubular carcinoma, metaplastic carcinoma, micropapillary carcinoma, mixed carcinoma

Viewer systems

Digital Lab (Smart in Media), EMPAIA, FullFocus (Paige), Pathflow (Gestalt), PathPresenter, Proscia, Sectra, Telemis, Tribun

Market Presence

On market since

May 2022

AI Platforms

Gestalt, Paige, PathPresenter, Proscia, Roche Navify, Sectra Amplifier Store, Smart in Media, Telemis, Tribun Health

Resellers

Not specified

Countries present

Not specified

Paying clinical customers

Not specified

Research/test users

Not specified

Pricing Information

Pricing model

One-time license fee, Pay-per-use, Subscription

Based on

Number of analyses

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