A global leader in digital diagnostics
Pathologists are key players in the clinical care continuum for cancer, their role being vital to diagnosis, prevention, treatment and monitoring. However, with an expected 60 percent increase in the number of cancer cases globally in the next two decades and a decrease in the number of pathologists relative to this diagnostic demand, there is a tremendous need to expedite workflows in pathology without sacrificing quality. This issue is further exacerbated by the fact that traditional pathology workflows rely on the time-consuming review of individual pathology slides under the microscope, creating bottlenecks that can lead to suboptimal outcomes for patients. In the past, efforts to have pathologists work longer hours or review cases faster had resulted in an increase in diagnostic errors. To address these challenges, Paige set out to create a diagnostic software platform that would optimize disease detection and characterization, improve capacity without compromising accuracy, keep the pathologist in control, and seamlessly integrate novel scanning technologies and evolving workflows. Leveraging proprietary AI techniques to recognize tissue patterns, Paige’s AI-based computational technology is uniquely positioned to help pathologists in their routine diagnostic workflow, resulting in clinical-grade products with the potential to transform the practice of pathology and ultimately improve patient care.
Paige’s offering include an FDA-cleared viewer called FullFocus™ and a portfolio of AI products that together provide an intuitive and integrated system for pathologists to triage, organize, evaluate, share, and store their work. The company’s flagship product is Paige Prostate, which is CE-marked for the clinical detection, grading and quantification of prostate cancer. Paige Prostate also received the first FDA breakthrough designation for an AI product in pathology. Studies have shown Paige Prostate reduced time to diagnosis and lower rates of unnecessary tests ordered, meaning faster turnaround times for clinicians and patients while ensuring an accurate read, with our latest study (yet to be published) also showed improvements in both pathologist sensitivity and specificity when using Paige Prostate, with additional improved efficiencies. As published in the Journal of Pathology, pathologists using Paige Prostate estimated a reduced time to diagnosis by approximately 65.5%, demonstrating the potential of the AI-powered Paige Prostate software in improving pathologists’ workflow in a real-world diagnostic environment. The same paper also showed Paige Prostate helped pathologists find 4 cancers that would have been missed otherwise.
Paige Prostate received the first FDA breakthrough designation for an AI product in pathology in 2019, which recognizes the groundbreaking nature of the technology and its potential to address urgent medical needs. As an AI technology, Paige Prostate is differentiated as it is the only system that has shown generalizability in the field. Paige Prostate has been tested on data from over 800 global institutions and on images scanned on multiple scanners with varying tissue slide preparation techniques, which other products in the space have yet to achieve. Generalizability in this space is critical, as site-wise calibration of algorithms can propagate errors and create brittle, biased systems. Furthermore, Paige Prostate was developed in close collaboration with pathologists and offers functionality that meets the demands of their daily workflow. The software offers an unparalleled digital slide viewing experience, speed-to-load, and immediate availability of AI results. Our proprietary AI visualization has been overwhelmingly preferred by pathologists, as we have worked to highlight, not obscure, areas of interest. From an implementation standpoint, Paige is also cloud-based, making the software fast to deploy with minimal ongoing maintenance needs while offering a secure and scalable solution.
Paige products are backed by independent studies that recognize the power and potential of computational pathology. In a recent study published in the Journal of Pathology, Paige Prostate demonstrated 100% sensitivity and reduced time to diagnosis by an estimated 65.5%, with potential to improve pathologists’ workflow in a real-world environment. In a separate study in Modern Pathology, Paige Prostate showed a sensitivity of 97.7% and positive predictive value of 97.9%, and a specificity of 99.3% and negative predictive value of 99.2% in identifying core biopsies with cancer in a data set derived from an independent institution. Speaking on the adoption of the Paige Platform, Leonard Medeiros da Silva, Ph.D., Pathologist with Oncoclinicas Precision Medicine (the integrated Genomics and Pathology operations at Grupo Oncoclinicas) stated: “We chose to go digital with Paige because it was the first AI cancer diagnostic platform that met our validation requirements for implementation into our clinical environment. Paige’s pipeline of AI diagnostic tools for other major cancer tumor types also differentiated them. The workflow and digital platform will also enable us to distribute work across our nationwide network of pathologists.” Further testing in the UK showed that Paige Prostate correctly classified all External Quality Assessment (EQA) prostate cases. The EQA datasets consist of difficult cases used to assess and train practicing pathologists on a regular basis.
Paige is bringing pathology into the digital era through its transformative technology platform. Paige Prostate has the potential to increase physician productivity while minimizing burnout. Furthermore, its AI-enabled technology has applications in a wide-range of cancers and can accelerate the detection of disease biomarkers both old and new.