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Mindpeak Breast ER/PR is a software for automated image analysis of digital histopathology images of human invasive mamma carcinoma tissue samples. It is a stand-alone software module that supports the analysis of digital images acquired by scanning the fixed and ER/PR stained samples of invasive ductal and lobular carcinoma without the need for manual fine-tuning to your lab.
Tumor cells are classified as not-stained (tumor negative) or stained (tumor positive). A corresponding positivity score is provided as the proportion of the number of tumor positive cells divided by the sum of tumor positive and tumor negative cells.
Mindpeak Breast ER/PR is a stand-alone software module for automated image analysis. For interaction with the medical device it must be integrated into an interactive image viewer software that allows the user to manually select or correct regions of interest for analysis with the medical device.
Mindpeak Breast ER/PR runs as a web service either in the cloud or on a dedicated on-premise server in the laboratory network. The cloud variant is specified and provided by Mindpeak or distribution partners and requires no additional hardware by the user. For minimum requirements for an on-premise solution, please contact us.
The medical device supports the staining for ER through the SP1 assay from Roche Ventana and the EP1 assay from Agilent Dako, as well as for PR through the clone 16 assay from Leica Biosystems, the clone 1E2 assay from Roche Ventana and the clone 1294 assay from Agilent Dako.
In conclusion of the identification, review, assessment, and analysis of the performance of the medical device, the medical device is considered to conform to the general safety and performance requirements according to the IVDD. For more information, please click here to see our study results.
Mindpeak Breast ER/PR detects and classifies cells into positively stained tumor and unstained tumor cells. One of its great advantages is its ability to differentiate between tumorous and non-tumorous structures, improving your scoring in the tumor microenvironment.
Image pre-calculation in the background allows instant visualization of all ER/PR detected and classified cells. Just load the digital slide and you are done!
The reliability of Mindpeak Breast ER/PR is unique: it provides accurate results even in challenging contexts as it was
developed with typical lab-specific variations in mind, such as slide preparation, staining and imaging.
Mindpeak Breast ER/PR supports a broad range of scanners and can easily be integrated into existing workflows.