Mindpeak Breast HER2

Mindpeak Breast HER2 is a software module for automated image analysis of digital histopathology images of human invasive mamma carcinoma tissue samples. It detects and quantifies HER2 expression in HER2-stained whole slide images of invasive ductal and lobular carcinoma, supporting pathologists in their analytic decision-making. The product is intended for Research Use Only; however, a Region of Interest (RoI) variant is available in the EU as a CE-IVD marked medical device.

The tool is developed by Mindpeak GmbH, a Hamburg-based company building AI and deep learning automation tools for visual diagnosis in cancer pathology. Mindpeak Breast HER2 is designed to reduce repetitive quantification tasks and provide explainable AI (xAI) results to support pathologist trust in automated outputs.

Analysis Output

• Detects and classifies IHC-stained tumor cells within whole slide images into five categories: not-stained (Negative tumor), partially stained (Partial tumor), completely but weakly stained (Complete weak tumor), completely and strongly stained (Complete strong tumor), and unspecific (Unspecific tumor).
• Unspecific tumor cells are excluded from HER2 score calculation due to indistinct staining qualities.
• Provides a HER2 score based on the distribution of classified tumor cells according to the ASCO/CAP 2023 clinical practice guideline: IHC 0 or 1+ (HER2 negative), IHC 2+ (equivocal/borderline), or IHC 3+ (HER2 positive).
• Differentiates between tumorous and non-tumorous structures to improve scoring accuracy within the tumor microenvironment.

Workflow Steps

1. Retrieve or select a digital image with immunohistochemical HER2 staining suited for automated analysis.
2. The whole slide analysis result from Mindpeak Breast HER2 is displayed automatically.
3. Review, adjust, and correct the automated analysis results using an integrated interactive viewer module.
4. Conclude a final analytic decision.

Key Capabilities

• 0-Click analysis: Image pre-calculation runs in the background, enabling instant visualization of all detected and classified HER2 cells upon loading a digital slide.
• Lab independence: Developed to account for typical lab-specific variations including slide preparation, staining, and imaging conditions, supporting consistent results across different laboratory environments.
• Broad scanner support: Compatible with a wide range of scanners and designed for integration into existing digital pathology workflows.
• Supported staining assays: Supports all HER2 staining assays in the standard module. The RoI variant specifically supports Pathway anti-HER2/neu clone 4B5 from Ventana, EP3 from Cell Marque, and HercepTest (clone A0485) from Agilent Dako.

Technical Requirements

• Software: Functions as a stand-alone software module and must be integrated into an interactive image viewer that allows manual review and adjustment of results at the individual cell level.
• Hardware: Runs as a web service either in the cloud or on a dedicated on-premise server within the laboratory network. The cloud variant is specified and provided by Mindpeak or distribution partners and requires no additional hardware from the user. On-premise minimum requirements are available on request.

Mindpeak Breast HER2 is available as a stand-alone module with cloud or on-premise deployment options. The CE-IVD marked RoI variant is available in the EU for use as a medical device. For research use deployments, the product supports all HER2 staining assays, with additional assay compatibility available upon inquiry with Mindpeak.