Built by Pathologists for Pathologists

Offering the only FDA approved AI-powered pathology product available for in vitro diagnostic use, Paige Prostate Detect

img-hero-pharma

Our Offerings

Paige develops novel AI applications together with a powerful platform to easily deploy AI in laboratories, putting the power of AI into the hands of pathologists. By combining proprietary computational pathology technology with data from millions of digitized glass slides and corresponding pathology reports, Paige technology can identify difficult or hard to recognize tissue patterns.

Clinical use

Paige’s advanced approach to AI development resulted in the first FDA approved AI-based pathology product available for in vitro diagnostic use, Paige Prostate Detect.

The Paige Platform provides Pathologists with Paige’s FullFocus® viewer and digital case manager, facilitating access to tissue AI applications as a fully integrated system with your LIS. Paige is uniquely positioned to help improve routine diagnostic workflow through digitization and the generation of novel insights from images to augment the difficult decisions that pathologists make every day. With its revolutionary technology and unwavering commitment to deliver powerful AI applications to pathologists everywhere, Paige is dedicated to transforming the field of pathology.

Clinical Use section

Paige provides results you can rely on, regardless of your role

Pathologists

Enhanced confidence and efficiency

Our AI and associated digital pathology workflows were developed in close consultation with our internal clinical team of pathologists and subspecialty experts together with external advisors worldwide. This was done to ensure that our products are relevant and impact positively on the pathologists workload through improved efficiency and decision support.

Lab Directors/Manager

Improve workflow efficiency and deep technical integration across your IT systems

You get access to an experienced advisory and support team that will streamline the integration of digital pathology within your lab and reduce the time it takes to go-live. Paige provides comprehensive training and support for users globally, priding itself in the customer success it experiences with labs worldwide.

IT and Security

A secure and scalable single platform

Provides users with the latest capabilities while maintaining a secure network infrastructure. Paige is an open platform that can seamlessly integrate with your lab’s existing LIS, LIMS, and a wide range of whole slide scanners.

App Developers and AI Vendors

Powerful tools to incorporate non-Paige AI applications

Paige provides a software development kit for app developers and AI vendors to deploy and fully integrate their apps on the Paige platform. 

FullFocus®

Advanced viewing of digital slides and AI results in one system

FDA CLEARED

CE-IVD

FullFocus® is a whole-slide image viewer for use in primary diagnosis1.

  • Fully web-based, facilitating remote access to digital slides
  • Open & Flexible Solution – Compatible with most major scanners, image formats, and LIS systems
  • Powerful tools for manual review of digital slides and powerful AI visualization for case prioritization and to support case reporting

FullFocus® is a whole-slide image viewer for use in primary diagnosis. Providing powerful case reviewing capabilities through efficiency-focused AI, FullFocus is a complete web-based and standalone solution that seamlessly integrates with all major scanners and file formats and supports bi-directional integration with most LIS systems, facilitating a truly open and collaborative experience.

img-platform-ui
paige bridge application

The Paige Platform

Paige’s comprehensive Platform provides a secure connection to a lab’s whole slide scanners, laboratory information systems (LIS) and other clinical information systems. Powering a lab’s digital pathology workflow, the Platform consists of data management, various levels of cloud storage options and the whole-slide image viewer, FullFocus®. 

Digital case management

Clinical worklist

digital case management

Store digitized slides with Paige

Paige offers secure and scalable cloud-based storage for pathology. The Paige Platform is built on top of Amazon Web Services and is deployed in multiple geographical regions, providing a reliable customer experience, with the flexibility to process sensitive data within that region.  Paige’s digital solution does not require capital expenditure or on-premise storage or management—Paige provides this all in the cloud.  Storage of whole slide images with Paige is a cost-effective and pragmatic solution to manage your digital pathology archives and workflows, ensuring fast access and low overheads. 

Our Products

Enabling more confident diagnoses

AI-powered applications for pathologists designed to reduce tedious review and improve diagnostic confidence and accuracy. 

Paige Prostate Suite

The Paige Prostate Suite is comprised of Paige Prostate Detect, Paige Prostate Grade & Quantify, and Paige Prostate Perineural Invasion. The AI applications available in the Paige Prostate Suite aim to assist in efficiencies of reads and reduce errors by identifying suspicious regions of interest. 

Paige Prostate

Paige Prostate Detect assists pathologists in the detection of foci that are suspicious for cancer during the review of scanned whole slide images (WSI) from prostate needle biopsies prepared from hematoxylin & eosin (H&E) stained formalin fixed paraffin embedded (FFPE) tissue. Paige Prostate Detect detects a region of interest with the highest likelihood of harboring cancer for further review by a pathologist. 

In one high profile study, Paige Prostate Detect had close to 100% sensitivity and 100% negative predictive value at patient level with reduced time to diagnosis by 65% (da Silva et al. J Pathology 2021;254:147-158 

In a study submitted to the FDA, and leading to the first FDA approval of a pathology AI application, Paige Prostate Detect was shown to significantly improve the sensitivity and specificity of the diagnosis of prostate cancer with an average 70% reduction in false negative diagnoses.

FDA CLEARED

CE-IVD

UKCA

Paige’s proprietary tissue map highlights areas suspicious for cancer and categorizes them by Gleason pattern to assist pathologists in evaluating values for overall tumor percentage and tumor length.  
 
Percentages and locations of Gleason patterns in a slide are conveniently displayed with just a click, for easy and efficient visualization. This application aims to reduce inter- and intra-observer variability, by helping pathologists standardize their approach to grading of prostate cancer. 

CE-IVD

UKCA

The Paige Prostate Perineural Invasion (PNI) application aids pathologists to identify the presence of suspicious foci around nerve fibers within the prostate for a quick detection of PNI in prostate biopsies. 

When combined with detection, Gleason grade and tumor percentage, PNI detection can provide pathologists comprehensive insights assisting is a more confident diagnosis. 

CE-IVD

UKCA

Paige Breast Suite

The Paige Breast Suite is comprised of Paige Breast and Paige Breast Lymph Node. The AI applications available in the Paige Breast Suite aim to assist in efficiencies of reads and reduce errors by identifying suspicious regions of interest. 

Paige Breast Lymph Node

Paige Breast is designed to aid pathologists in the detection of premalignant and malignant neoplasms.  Paige Breast is designed to draw attention to areas of cancer on the slide and enable pathologists to confidently identify small foci of cancer that can be easily missed. 

CE-IVD

UKCA

Paige Breast Lymph Node is designed to aid pathologists in the detection of metastases in breast cancer lymph node slides, guiding pathologists to areas suspicious for metastases, improving diagnostic confidence.  Showing over 98% sensitivity, Paige Breast Lymph Node can detect metastases of any size and prioritize cases for review. 

CE-IVD

UKCA

Results

The post-signout AI use identified one false negative result

6 of 210 cases were flagged for review, improving quality assurance process

Paige Prostate provided 100% Sensitivity

Back

Case Study

Weill Cornell Medicine had three genitourinary (GU) trained pathologist review 210 deidentified prostate biopsy cases. Their aim was to find if AI review can reduce under-diagnosis and improve quality.

Future Innovations

Expanding suite of pathology offerings

Paige will continue to innovate and bring new and exciting AI applications to market.  We will build these to the highest standards and seek regulatory approvals in Europe and North America to provide the confidence that pathologists need to use these every day.   Pulling on the extensive experience of medical, engineering and AI Science expertise, we expect to see new applications in breast, GI, derm, lung and other subspecialties over the next short period. 

This together with AI applications from third parties, including IHC applications, Paige aims to provide the widest and most impressive portfolio of AI applications to our pathologists. 

Important Safety Information

  1. FullFocus: Only cleared for use in primary diagnosis in the United States, European Union and the United Kingdom.
    In the United States, FullFocus (K201005) is cleared for clinical use with Philips Ultrafast scanner.  In the European Union and United Kingdom, FullFocus is CE & UKCA marked for clinical use with Philips Ultrafast and Leica AT2 scanners. Outside of the US, EU, and UK, use may be available for Research Use Only or a similar designation.  Otherwise, use is limited to Research Use Only. Not for use in  diagnostic procedures. 
  2. Paige Prostate Detect: In the United States, Paige Prostate Detect (DEN200080) is approved for clinical use with Philips Ultrafast Scanner.  In European Union and United Kingdom, Paige Prostate Detect is CE & UKCA marked for clinical use with Philips Ultrafast and Leica AT2 scanner. Outside of the US, EU, and UK, use may be available for Research Use Only or a similar designation Otherwise, use is limited to Research Use Only. Not for use in diagnostic procedures.
  3. Paige Prostate Grade & Quantify: For Research Use Only. Not for use in diagnostic procedures
  4. Paige Prostate Perineural Invasion (PNI): For Research Use Only. Not for use in diagnostic procedures.
  5. Paige Breast: For Research Use Only.  Not for use in diagnostic procedures.
  6. Paige Breast Lymph Node: For Research Use Only. Not for use in diagnostic procedures. For detailed regulatory and safety information see here