Public source
Reviewed 21 Jul 2026
Completeness Good (42%)
Paige Prostate Grade & Quantify is offered and sold as part of the Paige Prostate Suite. Categorizes areas suspicious for cancer by Gleason pattern, providing a primary and secondary Gleason grade prediction, as well as a percentage and linear measurement of tumor burden.
For use with digitized H&E stained prostate needle biopsy images. A qualified pathologist should employ appropriate procedures to ensure the quality of the images and use manual visualization and re-evaluate the product’s result before incorporation into the final diagnosis. The results shall only be considered after a pathologist’s initial review of the entire WSI.
Performance: Validated on a set of 1,000 prostate images. Slide level ISUP/Grade Group classification linear-weighted Kappa concordance was 0.78, slide level tumor length Pearson correlation coefficient was 0.83 and slide level tumor percentage Pearson correlation coefficient was 0.91.
Supported by 2 papers
Key features
Prostate cancer grading
General Information
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Regulatory Information
Pathway:
In Vitro Diagnostic Directive (IVDD)
Class:
General IVD Devices
Not verified by Health AI Register
Scanner Brands Certified for Use (CE-IVD)
Scanner Models Certified for Use (CE-IVD)
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Technical Specifications
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Source: Public | First published: Aug 1, 2025 | Last updated: Jul 21, 2026