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Mindpeak Breast HER2 RoI 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 which supports the analysis of digital images acquired by scanning the fixed and HER2 stained samples of invasive ductal and lobular carcinoma without the need for manual fine-tuning it to your lab.
Image analysis consists of the detection and classification of IHC stained tumor cells within predefined regions of interest (ROI). Tumor cells are classified according to membrane staining as not-stained (Negative tumor), partially stained (Partial tumor), complete but weakly stained (Complete weak tumor), complete and strongly stained (Complete strong tumor). Tumor cells exhibiting only nuclear or cytoplasmic are counted as unspecified (Unspecific tumor).
A HER2 score is provided based on the distribution of classified tumor cells within the regions of interest according to the latest clinical practice guideline of the American Society of Clinical Oncology and the College of American Pathologists (ASCO/CAP 2018): IHC 0 or 1+ (HER2 negative), IHC 2+ (equivocal/borderline) or IHC 3+ (HER2 positive).
Step 1: Retrieve or select an image with the immunohistochemical HER2 staining suited for diagnosis and automated
Step 2: Select regions of interest suited for diagnosis and automated analysis
Step 3: Mindpeak Breast HER2 RoI analyses the regions of interest and calculates the results
Step 4: Review, adjust and correct the results of the automated analysis in an integrated interactive viewer module
Step 5: Conclude a final diagnostic decision
Mindpeak Breast HER2 RoI 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 HER2 RoI 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 stainings of the Pathway anti-HER2/neu clone 4B5 assay from Ventana, EP3 from Cell Marque and HercepTest (sometimes referred to as clone A0485) 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 HER2 RoI detects and classifies cells in to 5 classes according to their membrane positivity. One of its
great advantages is its ability to differentiate between tumorous and non-tumorous structures, improving your scoring in the tumor microenvironment.
With Mindpeak Breast HER2 RoI you can manually choose the region of your interest on the whole slide image allowing for automated HER2 quantification of specific tumor subpopulations.
The reliability of Mindpeak Breast HER2 RoI 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 HER2 RoI supports a broad range of scanners and can easily be integrated into existing workflows.