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Breast | IHC quantification | Ki-67
The very first 0-click AI solution to detect and quantify Ki-67 in up to 4 tumor regions of interest according to the global scoring method
Mindpeak Breast Ki-67 4R 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 4R is available in the EU as a CE-IVD marked medical device. Outside the EU, Mindpeak Breast Ki-67 4R is Research Use Only, not for use in diagnostic procedures.
Detailed information on Breast Ki-67 4R
Output
Image analysis consists of the detection and classification of IHC stained tumor cells within whole slide images and
identification of up to four tumor regions of interest according to the global scoring method. Tumor cells are classified as
not-stained (tumor negative) or stained (tumor positive). A global unweighted score and a global weighted score is provided.
Workflow
Step 1: Retrieve or select an image with the immunohistochemical Ki-67 staining suited for diagnosis and automated
analysis
Step 2: Mindpeak Breast Ki-67 4R analyses the whole slide image and calculates the results
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
Mindpeak Breast Ki-67 4R 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
Mindpeak Breast Ki-67 4R 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
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
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.
Find out how Breast Ki-67 4R can work for you
Identification & Quantification
Mindpeak Breast Ki-67 4R 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 4 tumor regions.
Lab Independent
The reliability of Mindpeak Breast Ki-67 4R 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 4R supports a broad range of scanners and can easily be integrated into existing workflows.
Find out how Breast Ki-67 4R can work for you
