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Breast | IHC quantification | Ki-67

The first plug-and-play AI solution to detect and quantify Ki-67 within predefined RoIs of breast cancer tissue

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

Detailed information on Breast Ki-67 RoI

Output

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Image analysis consists of the detection and classification of IHC stained tumor cells within predefined regions of interest (ROI). 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: Select regions of interest suited for diagnosis and automated analysis.

Step 3: Mindpeak Breast Ki-67 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.

Required Software

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Mindpeak Breast Ki-67 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.

Required Hardware

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Mindpeak Breast Ki-67 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. Minimum requirements for a dedicated on-premise server are:

  • 64 bit Processor Intel Core i5 or better
  • 8 GB RAM
  • 40 GB hard drive
  • Nvidia GeForce GTX 1080 GPU or better

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 see our study result [link to study.

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Identification & Quantification

Mindpeak Breast Ki-67 RoI 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.

RoI

With Mindpeak Breast Ki-67 RoI you can manually choose the region of your interest on the whole slide image allowing for automated Ki-67 quantification of specific tumor subpopulations.

Lab Independent

The reliability of Mindpeak Breast Ki-67 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.

Easy Integration

Mindpeak Breast Ki-67 RoI supports a broad range of scanners and can easily be integrated into existing workflows.

Lab Independent

The reliability of Mindpeak Breast Ki-67 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.

Interested in finding out more?

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