# Paige Prostate Detect

Source: https://onco.cc/drugs/paige-prostate/  
OnCo record `paige-prostate` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The first AI for reading biopsy slides authorised by the FDA, which points pathologists to prostate cancer they might otherwise miss.

## Summary

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.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-10
- Tags: test
- Brand: Paige Prostate
- Modality: AI digital pathology detection software (prostate biopsy)
- Mechanism: Deep-learning model trained on tens of thousands of whole-slide images flags biopsy slides and regions suspicious for cancer for pathologist review.
- Approvals: US 2021: Aid to pathologists in detecting areas suspicious for cancer on prostate needle biopsy slides (De Novo); EU 2019: CE mark

## Notes

- 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.

## Sources

- FDA De Novo DEN200080: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200080
- FDA press release (2021) (archived copy): https://web.archive.org/web/20250427051345/https://www.fda.gov/news-events/press-announcements/fda-authorizes-software-can-help-identify-prostate-cancer

## Connected records

- cancers: [Prostate cancer](https://onco.cc/cancers/prostate/)
- technologies: [Digital pathology & AI](https://onco.cc/technologies/digital-pathology-ai/), [Pathology & radiology foundation models](https://onco.cc/technologies/pathology-foundation-model/), [Whole-slide scanners and image management](https://onco.cc/technologies/whole-slide-scanners/)
- companies: [Paige AI](https://onco.cc/companies/paige/)
- roadmaps: [AI in oncology roadmap: pattern readers → foundation models → agents in the workflow](https://onco.cc/roadmaps/ai-oncology-roadmap/)

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