Paige Lymph Node
Better Breast Cancer Detection
Paige Lymph Node is an AI application designed to assist pathologists in the detection of breast cancer metastases in lymph node tissue, which is a challenging and time-consuming task for pathologists. Trained with over 32,000 digitized hematoxylin and eosin (H&E) stained lymph node slides, the platform can detect the presence of breast cancer metastases with near-perfect sensitivity.
In October 2023, this innovation became the first of its kind to receive the FDA’s Breakthrough Device Designation because it has the potential to provide a more effective diagnosis for cancer. The system highlights each area of concern on a suspicious lymph node slide for further review by the pathologist, making them more efficient in the identification of even small micro metastases and enhancing confidence in their final diagnosis. However, even with the breakthrough designation, Paige Lymph Node is still for research use only in U.S. and should not be used in diagnostic procedures.
Another benefit of the application that Paige created is TissueMap, which uses opacity to highlight the relevant suspicious areas of tissue rather than overlaying colors like traditional heatmaps which might obscure the view of the slide. This makes it easier for pathologists to clearly see all the application’s findings.
Current research involving Paige Lymph Node demonstrated near-perfect classification sensitivity and the ability to help improve pathologist sensitivity on small micromets (0.2-0.5mm) and isolated tumor cells (ITCs) by over 25%. Paige Lymph Node also supported pathologists in drastically improving their efficiency by a total of 70%. These statistics are based on an investigational clinical study involving three pathologists and data from 148 patients.