Mindpeak Breast Ki-67 HS

Mindpeak Breast Ki-67 HS is a software module for automated image analysis of digital histopathology images of human invasive mamma carcinoma tissue samples. It detects and quantifies Ki-67 expression in tumor regions of interest using the hotspot method, requiring no manual fine-tuning to individual laboratory settings. The tool is designed for pathologists and laboratory professionals working with invasive ductal and lobular carcinoma samples stained with Ki-67 immunohistochemistry (IHC).

In the EU, Mindpeak Breast Ki-67 HS is available as a CE-IVD marked medical device. Outside the EU, it is designated for Research Use Only and is not intended for use in diagnostic procedures.

Analysis Output

• Detects and classifies IHC-stained tumor cells within whole slide images as either tumor positive (stained) or tumor negative (not stained).
• Identifies one or several tumor hotspots within the whole slide image.
• Provides a proliferation score calculated as the proportion of tumor positive cells divided by the total of tumor positive and tumor negative cells.
• Differentiates between tumorous and non-tumorous structures to improve scoring accuracy in the tumor microenvironment.

Workflow Steps

1. Retrieve or select a whole slide image with Ki-67 immunohistochemical staining suited for diagnosis and automated analysis.
2. The result of the whole slide analysis is displayed automatically.
3. Review, adjust, and correct the results of the automated analysis using an integrated interactive viewer module.
4. Conclude a final diagnostic decision based on the reviewed results.

Key Features and Capabilities

• 0-Click analysis: Image pre-calculation runs in the background, enabling instant visualization of up to four tumor hotspots without requiring manual input.
• 400 cells tool: Automatically selects an area for analysis containing 400 tumor cells.
• Lab independence: Developed with typical lab-specific variations in mind — including differences in slide preparation, staining, and imaging — to provide accurate results across challenging contexts.
• Broad scanner support: Compatible with a wide range of scanners and designed for integration into existing laboratory workflows.

Supported Assays

• MIB-1 pharmDx assay from Agilent Dako
• 30-9 antibody assay from Roche Diagnostics

Technical and Deployment Requirements

• Mindpeak Breast Ki-67 HS is a stand-alone software module that must be integrated into an interactive image viewer software to allow manual selection or correction of regions of interest.
• Runs as a web service, available either as a cloud deployment specified and provided by Mindpeak or distribution partners, or as an on-premise server installation within the laboratory network.
• The cloud variant requires no additional hardware from the user; minimum hardware requirements for on-premise deployment are available on request.

Mindpeak Breast Ki-67 HS has been assessed for conformance with general safety and performance requirements according to the IVDD. The tool is developed by Mindpeak GmbH, based in Hamburg, Germany, with additional presence in Cambridge, MA, USA. Mindpeak focuses on AI and deep learning-based automation tools for visual diagnosis in pathology, with an emphasis on explainable AI (xAI) to support pathologist trust in automated results.