Paige Prostate Detect
The first AI for reading biopsy slides authorised by the FDA, which points pathologists to prostate cancer they might otherwise miss.
Overview
Paige Prostate received FDA De Novo authorisation on 21 September 2021 (DEN200080), the first artificial-intelligence software for pathology. In the FDA reader study, pathologists using the software improved cancer detection on prostate biopsy slides, with the agency reporting a 7.3% improvement in detection and a reduction in false negatives. It runs on scanned whole-slide images and highlights areas of concern rather than making the diagnosis. Paige, a Memorial Sloan Kettering spin-out, went on to build the Virchow foundation models with Microsoft, and the software is CE-marked in Europe.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2021 | Aid to pathologists in detecting areas suspicious for cancer on prostate needle biopsy slides (De Novo) |
| EU | 2019 | CE mark |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Notes
top- What a result means: nothing changes for the patient directly; the pathologist still makes the diagnosis, with a second pair of algorithmic eyes reducing missed small cancers.
Latest papers
topQuery for this drug: (TITLE:"Paige Prostate Detect" OR ABSTRACT:"Paige Prostate Detect" OR TITLE:"Paige Prostate" OR ABSTRACT:"Paige Prostate") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Paige Prostate Detect, not a curated reading list.
Pages like this
not linked directly; found by shared links- ProductOncotype DX Genomic Prostate Score
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- CompanyIndica Labs
Shares Whole-slide scanners and image management, Digital pathology & AI.
- PersonThomas J. Fuchs
Shares Pathology & radiology foundation models, Digital pathology & AI, Prostate cancer.
- IdeaAI second reads to stop borderline lesions being upgraded to cancer
Shares Paige AI, Pathology & radiology foundation models, Digital pathology & AI.