Paige

Paige develops computational pathology products that help patients and their care teams make informed treatment decisions. The company created a platform for pathologists designed to make their workflow more efficient and increase diagnostic accuracy. During the platform's development, Paige collaborated with pathologists to gain insight into their professional needs and cater to them. Primarily, the company's products provide data to pathologists that enables them to arrive at more precise diagnoses for patients. Paige is the first company to have received FDA breakthrough designation for computational pathology products.

The company's workforce is comprised of experts in pathology, machine learning, healthcare, and business. Besides extracting additional information from digital slides to help pathologists perform their diagnostic work efficiently and accurately, Paige also aims to extract new diagnostic information from pathology slides and patient samples that have the potential to support informed treatment pathways for patients. Additionally, Paige technology helps life sciences companies to evaluate and design personalized treatments for patients.

Paige's digital pathology software platform includes viewing and storage capabilities and is compatible with other digital pathology solutions, including most scanners, monitors, and laboratory information systems (LIS). The platform comprises the following products:

• FullFocus—An FDA-cleared, CE-marked viewer for primary diagnosis. FullFocus is designed for pathologists to utilize computational pathology products as they become available for clinical use.

• Data Management—A scalable storage solution.

According to Paige.ai, the company's products offer a variety of features:

• a user experience centered on the pathologist's needs
• fast performance in loading and viewing digital slides
• access to digital slides for multiple users from any internet-enabled location
• secure and scalable storage
• economical operation without upfront capital expenses
• prompt deployment and minimal ongoing maintenance requirements
• interoperability with most scanners, monitors, and LIS

According to Paige, Paige Prostate Detect is the first and only FDA-approved software solution proven to improve accuracy of prostate biopsy diagnosis. This approval allows for in vitro diagnostic (IVD) use of Paige Prostate Detect in combination with the FullFocus digital pathology viewer in the analysis of prostate needle biopsies. Paige Prostate Detect has been tested on slides from more than 200 institutions and validated in multiple peer-reviewed studies in international scientific journals. Paige claims that the software solution offers these advantages:

• improvement in diagnostic accuracy and significant reduction of detection errors
• increase of pathologists’ confidence and ability to detect the presence of prostate cancer
• improvement of laboratory workflows so as to enable pathologists to streamline their process and reduce turnaround time for patients

Paige Breast is a breast cancer detection solution that scans breast tissue for cancer, subtypes of neoplasms, and metastases in lymph nodes. The software has received a CE mark for the identification of suspicious features on breast tissue and for slide level information regarding the presence of cancer. Paige Breast's capabilities include the following:

• neoplasm subtyping that classifies neoplasms as ductal, lobular, in-situ, or invasive

• The ability to identify ductal and lobular atypia and rare morphologies including mucinous, tubular, apocrine, micropapillary, and solid papillary

• additional functionalities planned to be introduced in the future include microinvasion and calcification detection

Organizations and companies in the life sciences sector can use the Paige platform to create a differentiated biomarker for pipeline and portfolio products. The platform includes the following capabilities:

• fast-tracking of the biomarker discovery process to support pipeline programs
• facilitation of discovery of novel biomarkers
• creation of consistent digital analogues to existing biomarker assays
• characterization of tissue to inform clinical trial design