Company now has four CE marks in its portfolio for digital and computational pathology products
Achievements build on company’s CE marks for first-in-class Paige Prostate Cancer Detection product and digital pathology viewer FullFocus in 2019
NEW YORK – Paige, a global leader in AI-based digital diagnostics, today announced it received a CE mark for Paige Breast, its breast cancer detection software that indicates suspicious areas for further review to pathologists evaluating breast biopsies. The company also received a CE mark for Paige Prostate Grading & Quantification, a digital diagnostic that offers slide level information for primary and secondary Gleason patterns and tumor size to inform treatment planning. With these CE marks, both products are now available for use in laboratories and hospitals in the European Economic Area, Switzerland and the UK.
“The CE mark in breast cancer represents an important regulatory validation for our computational pathology products as we broaden our applications in oncology, while the CE mark in prostate cancer adds valuable grading and quantification features for our existing CE marked Paige Prostate offering,” said Leo Grady, Ph.D., Chief Executive Officer of Paige. “We continue to rapidly advance new products that improve pathology workflow and improve diagnostic confidence for some of the most prevalent cancers including breast cancer. I am incredibly grateful to all the Paige team members and our physician colleagues worldwide who have helped advance this technology in order to ultimately optimize patient outcomes.”
Paige Breast Enables Slide and Case Level Predictions on Breast Cancer Presence
For pathologists diagnosing breast cancer – the most commonly diagnosed cancer among women in European countries1 – the potentially large volume of breast tissue slides to be reviewed can pose challenges for workload management and pathologist productivity. Paige Breast is designed to draw pathologists’ attention to concerning features on a breast tissue slide and provides slide and case level predictions about the presence of cancer. This functionality enables pathologists to more easily, efficiently and confidently identify small foci of cancer that can be easily missed.
“By reducing inter-observer variability, uncertainty, and time, this technology will enable pathologists to drive informed treatment more efficiently, helping to ensure patients receive the best care,” said Matthew Hanna, M.D., Director of Digital Pathology Informatics at Memorial Sloan Kettering Cancer Center. “These technologies have the potential to increase physician productivity while minimizing burnout, particularly for diseases with high incidence, such as breast cancer, where hospitals may be faced with a large volume of patient cases.”
Paige continues to enhance functionality for Paige Breast, including quantification and subtyping functionality, for future deployment.
Streamlining Prostate Cancer Diagnosis Through AI-based Grading and Quantification
Grading and quantification of prostate tissue are time consuming tasks that are often subjective with high inter-observer variability as part of the diagnosis process. With the addition of the new grading and quantification functionality, Paige Prostate can enhance diagnostic confidence for the pathologist while increasing consistency and standardization.
Paige Prostate Grading & Quantification provides slide level information for primary and secondary Gleason patterns, tumor length and tumor percentage. The product provides visual overlays that indicate the specific regions of the slide corresponding to each Gleason pattern, which can reduce the time it takes a pathologist to determine and measure a grade. Furthermore, Paige Prostate Grading & Quantification exhibits high concordance with sub-specialized pathologists which means the technology has the potential to decrease a pathologist’s need to defer cases for additional review without compromising diagnostic accuracy. This technology thereby streamlines workflows to decrease turnaround time for the patient and clinician.
Dr. Matthew Hanna has a compensated consulting relationship with Paige. MSK has intellectual property rights and associated financial interests related to Paige by virtue of licensing agreements between MSK and Paige.