Mindpeak Breast ER/PR

Mindpeak Breast ER/PR is a software module for automated image analysis of digital histopathology images of human invasive mamma carcinoma tissue samples. It detects and quantifies estrogen receptor (ER) and progesterone receptor (PR) expression in breast cancer cells, classifying tumor cells as positively stained or unstained and providing a corresponding positivity score. The tool is designed for pathology laboratories and supports analysis of invasive ductal and lobular carcinoma samples without requiring manual fine-tuning to individual lab settings.

Mindpeak Breast ER/PR is available in the EU as a CE-IVD marked medical device. Outside the EU, it is intended for Research Use Only and is not for use in diagnostic procedures.

Key Capabilities

• Detects and classifies cells into positively stained tumor cells and unstained tumor cells across whole slide images.
• Provides a positivity 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, supporting more accurate scoring within the tumor microenvironment.
• Uses image pre-calculation in the background to enable instant visualization of all detected and classified ER/PR cells upon loading a digital slide, requiring zero manual clicks to initiate analysis.
• Delivers consistent results across varying lab conditions, including differences in slide preparation, staining, and imaging.
• Supports a broad range of scanners and can be integrated into existing laboratory workflows.

Supported Assays and Samples

• ER staining: SP1 assay from Roche Ventana and EP1 assay from Agilent Dako.
• PR staining: clone 16 assay from Leica Biosystems, clone 1E2 assay from Roche Ventana, and clone 1294 assay from Agilent Dako.
• Supports fixed and ER/PR stained samples of invasive ductal and lobular carcinoma.

Workflow Steps

1. Retrieve or select a digital image with immunohistochemical ER/PR staining suited for diagnosis and automated analysis.
2. The whole slide analysis result from Mindpeak Breast ER/PR is displayed automatically.
3. Review, adjust, and correct the results of the automated analysis using an integrated interactive viewer module at the individual cell level.
4. Conclude a final diagnostic decision based on the reviewed results.

Technical and Integration Requirements

• Mindpeak Breast ER/PR is a stand-alone software module that must be integrated into an interactive image viewer software to allow manual review and adjustment of results at the individual cell level.
• Runs as a web service, available 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 its distribution partners and requires no additional hardware from the user.
• On-premise deployment is available; minimum hardware requirements can be obtained by contacting Mindpeak directly.

The device has been assessed for conformance with general safety and performance requirements according to the IVDD. Mindpeak GmbH, founded in 2018 and headquartered in Hamburg, Germany, also maintains a presence in Cambridge, MA, USA.