Paige’s AI Tool for Multi-Tissue Cancer Detection Gets FDA's Breakthrough Device Designation

Paige has received Breakthrough Device designation from the U.S. FDA for PanCancer Detect, an AI-based diagnostic tool intended to assist pathologists in identifying cancer across a range of tissues and organs. This is reportedly the first such designation for a multi-tissue AI application in pathology.

PanCancer Detect is part of the Paige Alba platform and is currently designated for research use only. It uses machine learning to flag foci suspicious for malignancy, including both common and rare cancer types, across different anatomic sites. The system is designed to support prioritization of high-risk cases and enhance diagnostic accuracy, potentially reducing time to diagnosis in settings with limited pathology resources.

See also: Paige Introduces Multi-Modal AI for Enhanced Precision Oncology and Drug Discovery

Alba is Paige’s AI-enabled software environment that combines pathology images, radiology data, and patient information into a unified interface. It is designed to assist with workflow tasks such as reviewing digital slides, highlighting areas of concern, summarizing clinical data, and facilitating case coordination. Alba includes additional features such as interactive controls, molecular biomarker screening tools, and options for use in multidisciplinary settings like tumor boards. While in beta, Alba incorporates both research-use-only and FDA-cleared components depending on the configuration.

Paige has previously secured Breakthrough Device designations for its Prostate Detect and Lymph Node tools, with Prostate Detect becoming the first FDA-authorized AI application in pathology. The company also holds FDA clearance for its FullFocus whole-slide image viewer used in primary diagnosis.

The Breakthrough Device Program is intended to expedite development and regulatory review of technologies that offer more effective diagnosis or treatment for serious conditions. Paige’s PanCancer system builds on its earlier work applying AI across large-scale datasets of digitized pathology slides, with the aim of improving scalability and consistency in cancer diagnostics.

In August 2024, Paige open-sourced its AI models Virchow and PRISM.

Cover image: Paige Alba software, source: paige.ai

Topics: AI & Digital