Mindpeak Breast Ki-67 4R

Mindpeak Breast Ki-67 4R is a stand-alone 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 up to four tumor regions of interest according to the global scoring method, requiring no manual fine-tuning to individual laboratory settings. The tool is designed for pathology workflows involving invasive ductal and lobular carcinoma and is available in the EU as a CE-IVD marked medical device. Outside the EU, it is for Research Use Only and not intended for use in diagnostic procedures.

Mindpeak Breast Ki-67 4R is developed by Mindpeak GmbH, a Hamburg-based company building AI and deep learning-based automation tools for visual diagnosis in cancer pathology. The software is intended to assist cancer experts in producing reliable and reproducible diagnoses by automating cell and biomarker quantification tasks.

Output and Analysis Capabilities

• Detects and classifies IHC-stained tumor cells within whole slide images as either stained (tumor positive) or not-stained (tumor negative).
• Identifies up to four tumor regions of interest according to the global scoring method.
• Provides both a global unweighted score and a global weighted score.
• Differentiates between tumorous and non-tumorous structures, supporting more accurate scoring within the tumor microenvironment.
• Image pre-calculation in the background enables instant visualization of up to four tumor regions without requiring manual user input (0-click operation).

Workflow Steps

1. Retrieve or select a whole slide image with immunohistochemical Ki-67 staining suited for diagnosis and automated analysis.
2. Mindpeak Breast Ki-67 4R analyses the whole slide image and calculates results 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.

Supported Samples and Assays

• Supports analysis of fixed and Ki-67 stained samples of invasive ductal and lobular carcinoma.
• Compatible with the MIB-1 pharmDx assay from Agilent Dako.
• Compatible with the 30-9 antibody assay from Roche Diagnostics.

Lab Independence and Integration

• Developed with typical lab-specific variations in mind, including differences in slide preparation, staining, and imaging, allowing accurate results across varied laboratory contexts.
• Supports a broad range of scanners and is designed for integration into existing pathology workflows.
• Must be integrated into an interactive image viewer software that allows users to manually select or correct regions of interest.

Deployment and Hardware Requirements

• Runs as a web service, available either as a cloud deployment or as an on-premise server within the laboratory network.
• The cloud variant is specified and provided by Mindpeak or its distribution partners and requires no additional hardware from the user.
• Minimum requirements for on-premise deployment are available on request from Mindpeak.

Mindpeak Breast Ki-67 4R has been assessed for conformity with the general safety and performance requirements under the IVDD. The product is CE-IVD marked for use within the EU. Mindpeak operates offices in Hamburg, Germany and Cambridge, Massachusetts, USA.