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Breast | IHC quantification | Ki-67

The very first 0-click AI solution to detect and quantify Ki-67 in tumor regions of interest according to the hotspot method

Mindpeak Breast Ki-67 HS 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 Ki-67 stained samples of invasive ductal and lobular carcinoma without the need for manual fine-tuning it to your lab.

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Mindpeak Breast Ki-67 HS is available in the EU as a CE-IVD marked medical device. Outside the EU, Mindpeak Breast Ki-67 HS is Research Use Only, not for use in diagnostic procedures.

Detailed information on Mindpeak Breast Ki-67 HS

Output

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Image analysis consists of the detection and classification of IHC stained tumor cells within whole slide images and
identification of one or several tumor hotspots. Tumor cells are classified as not-stained (tumor negative) or stained (tumor positive). A corresponding proliferation score is provided as the proportion of the number of tumor positive cells divided by the sum of tumor positive and tumor negative cells.

Workflow

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Step 1: Retrieve or select an image with the immunohistochemical Ki-67 staining suited for diagnosis and automated
analysis

Step 2: The result of Mindpeak Breast Ki-67 HS 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 diagnostic decision

Required Software

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Mindpeak Breast Ki-67 HS 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.

Required Hardware

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Mindpeak Breast Ki-67 HS 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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The medical device supports the staining of the MIB-1 pharmDx assay from Agilent Dako and the 30-9 antibody assay from Roche Diagnostics.

Performance

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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.

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Find out how Breast Ki-67 HS can work for you

Identification & Quantification

Mindpeak Breast Ki-67 HS 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.

0-Click

Image pre-calculation in the background allows instant visualization of up to four tumor hotspots.

400 cells tool

Use the 400 cells tool to automatically select an area for analysis containing 400 tumor cells

Lab Independent

The reliability of Mindpeak Breast Ki-67 HS 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 Ki-67 HS supports a broad range of scanners and can easily be integrated into existing workflows

Find out how Breast Ki-67 HS can work for you

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