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Breast | IHC quantification | HER2

0-Click AI solution to detect and quantify HER2 in breast cancer tissue

Mindpeak Breast HER2 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.

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Mindpeak Breast HER2 is intended for Research Use Only, not for use in diagnostic procedures. Additionally, for Breast HER2 we offer a RoI Variant, which is available in the EU as a CE-IVD marked medical device.

Detailed information on Mindpeak Breast HER2

Output

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Image analysis consists of the detection and classification of IHC stained tumor cells within whole slide images. Tumor cells are classified as not-stained (Negative tumor), partially stained (Partial tumor), completely but weakly stained (Complete weak tumor) or completely and strongly stained (Complete strong tumor). If tumor cells cannot be classified in one of these categories, they are classified as unspecific (Unspecific tumor). Unspecific tumor cells are not included in the calculation of the HER2 score due to the indistinct staining qualities.

A HER2 score is provided based on the distribution of numbers 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 2023): IHC 0 or 1+ (HER2 negative), IHC 2+ (equivocal/borderline) or IHC 3+ (HER2 positive).

Workflow

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Step 1: Retrieve or select an image with the immunohistochemical HER2 staining, suited for automated analysis.

Step 2: The result of Mindpeak Breast HER2 whole slide analysis is displayed.

Step 3: Review, adjust and correct the results of the automated analysis in an integrated interactive viewer module. 

Step 4: Conclude a final analytic decision.

Required Software

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Mindpeak Breast HER2 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 review and adjust the results of the Mindpeak Breast HER2 on an individual cell level.

Required Hardware

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Mindpeak Breast HER2 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.

Supported Samples

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Mindpeak Breast HER2 supports all HER2 staining assays.

The RoI variant 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. For information on the support of additional staining assays, please get in touch with Mindpeak.

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Detection and quantification of breast cancer cells

Identification & Quantification

Mindpeak Breast HER2 is designed to detect and classify tumor cells into categories: negative, partial, complete weak, or complete strong. One of its significant advantages is its ability to differentiate between tumorous and non-tumorous structures, thereby enhancing the accuracy of scoring within the tumor microenvironment. This capability ensures more reliable and precise assessments of HER2 expression, aiding pathologists in their analytic decision-making.

0-Click

Image pre-calculation in the background allows instant visualization of all HER2 detected and classified cells. Just load the digital slide and you are done!

Lab Independent

The reliability of Mindpeak Breast HER2 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.

Easy Integration

Mindpeak Breast HER2 supports a broad range of scanners and can easily be integrated into existing workflows.

Find out how Mindpeak Breast HER2 can work for you

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