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.
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.
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
- Jung et al., Artificial intelligence system shows performance at the level of uropathologists for the detection and grading of prostate cancer in core needle biopsy: an independent external validation study, Modern Pathology, 2022.
- Schmidt et al., External validation of an artificial intelligence model for Gleason grading of prostate cancer on prostatectomy specimens, BJU International, 2024.
- Calle et al., COMPARISON OF PROSTATE BIOPSY GRADE OBTAINED BY HUMAN PATHOLOGISTS VERSUS AN ARTIFICIAL INTELLIGENCE ALGORITHM FOR PREDICTING BIOCHEMICAL RECURRENCE AFTER RADICAL PROSTATECTOMY, The Journal of Urology, Supplement. 2023.
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 |