Paige.AI
Multi-cancer AI analysis (PanCancer Detect) for pathology: FDA Breakthrough Device 2025, detection across all tissue types
Overview
Paige.AI has developed PanCancer Detect, an AI module detecting cancers across 21 biopsy types and 25 tissue resection types, while also detecting rare cancers and variants. In April 2025, the FDA granted Paige a Breakthrough Device designation for PanCancer Detect for multi-site cancer diagnosis, a first for generalist pathology AI. Paige internally validates AUC 0.95 performance on common and rare cancers. The tool addresses a real shortage: pathology demand outpaces pathologist supply, and generalist AI tools can ease diagnostic workflow. Paige Alba is Paige's end-to-end platform (digital slides plus AI plus workflow).
Paige.AI does not offer a French-language interface. Pricing is not public: customers use Paige's Alba platform or integrate PanCancer algorithms into their LIS via API. The Breakthrough Device designation is FDA authorization acceleration, not commercial approval: clinical deployments are underway but full commercialization is likely 2026-2027. The absence of formal regulatory approval outside the US (no clear CE-IVD marking or equivalent) leaves use in regulated healthcare settings uncertain. Access for small European labs remains limited: Paige targets industrial-scale structures and academic hospital networks.
Our verdict
Best for large labs and academic hospital networks seeking very generalist pathology AI capable of screening cancers across all tissue types without specialization. Not for you if you run a small clinic: Paige.AI remains a pioneer solution, not yet widely accessible commercially, with no clear regulatory path in Europe.