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DeepDx Prostate (IVD)
DeepDx Prostate analysis showing color-coded overlays for Gleason Patterns 3 (yellow), 4 (orange), and 5 (red).

DeepDx Prostate

DeepDx Prostate is a CE-marked, artificial intelligence-based software tool intended for the in vitro diagnostic analysis of digitized whole slide images (WSIs) of H&E-stained prostate core needle biopsies. Utilizing deep learning, it provides quantitative and qualitative insights to assist pathologists in detecting and localizing prostate adenocarcinoma. It features automated Gleason scoring, Gleason grading, and measurement of tumor extent, including tumor length and percent tumor involvement values. Clinically validated, it seamlessly integrates into diagnostic workflows to support confident therapeutic decision-making.

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Contattaci

DeepDx Prostate is CE-marked for in vitro diagnostic use. Not available in all countries. Check with your local Leica Biosystems representative to confirm product availability in your market.

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Performance

DeepDx Prostate showed 98.7% sensitivity, 96.9% specificity, 98.3% accuracy, and 0.922 quadratic-weighted kappa against a rigorous three-pathologist reference standard in its external validation study.1 Reading with the software showed 34% time reduction in this study. Independent evaluations further demonstrated clinical utility: a Stanford University validation confirmed reliable automated Gleason grading,2 while a Johns Hopkins study demonstrated AI-derived grades predict long-term oncologic outcomes.3

DeepDx Prostate in Aperio HALO AP Software Demonstration

Explore the future of prostate cancer diagnosis with DeepDx Prostate. DeepDx Prostate seamlessly integrates within the Aperio HALO AP platform to analyze H&E-stained prostate core needle biopsies.

After selecting a case, run the DeepDx Prostate assay to view the H&E slides and analysis results. Results include comprehensive diagnostic and quantitative data displayed in the assay panel, featuring ISUP Grade Groups, Gleason Scores, Gleason pattern proportions, tumor lengths, and tissue lengths. Visual overlays include color-coded, gland-level segmentation masks for Gleason Patterns 3, 4, and 5.

Specifications

Supported File Formats: .svs, .tif, .tiff, .ndpi, .bif