Paige announces first ever CE Mark for Deep Learning in Pathology

First-in-class, advanced technology for improved prostate cancer detection

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Nov 12, 2019, 04:11 ET

NEW YORK, Nov. 12, 2019 /PRNewswire/ -- Paige, the leader in clinical-grade computational pathology, today announced CE Mark for Paige Prostate, its first-in-class prostate cancer detection solution, along with Paige Insight, its AI-native digital pathology viewer, both for primary diagnosis. The solutions are vendor neutral and allow for seamless collaboration across teams and sites. With CE Mark, these solutions will be available to European pathology practices, many of which are facing increased case volumes and shortages of qualified pathologists.

Giving Pathologists More Information

Paige Prostate shown on Insight: Pathologists can interact with AI to streamline their workflow and better detect areas with cancer

Pathology is the cornerstone of pivotal diagnoses for patients, especially in cancer. This essential practice faces challenges from lower reimbursement and increased productivity demands, yet the tools used in practice have changed little in the last decade. Today, most pathology assessments are performed by viewing glass slides with microscopes, and second opinion requests require shipping these fragile samples between sites. Digitizing the practice of pathology presents big opportunities for advancing the field, yet the lack of interoperability between fragmented solutions and insufficient efficiency gains have hindered its general adoption.

Paige's offerings enable pathologists to overcome these barriers: Insight allows pathologists to view, process and collaborate on whole digitized slides from different sites and scanners, while leveraging the power of Paige's AI-based modules with the potential to provide improved diagnostic quality, higher pathology throughput and lower costs. The first of these, Paige Prostate, has achieved clinical grade accuracy: demonstrating equivalent performance in images taken with multiple scanners and on slides prepared at hundreds of institutions.

CE Mark is an important milestone for Paige," said Dr. Leo Grady, CEO. "Pathology practices around the world have begun to embrace digital pathology and can begin to realize the potential of the technology with real-time quality assurance, gains in productivity, and improved collaboration across sites. We believe in empowering pathologists with additional insights from these rich pathology images, so they can make more effective, confident diagnoses."

Modern software for critical decisions

Prostate cases are among the most difficult and time-consuming biopsies for pathologists to review, grade, and report. The assessment is nuanced and requires close inspection of many tissue samples. This difficult assessment can lead to discordance in findings between pathologists as well as diagnostic errors. In one study, 9% of cases received for a second opinion at a leading institution resulted in revisions to original findings¹. Current guidelines require re-review of a small percentage of cases since additional reviews of all cases and slides by qualified pathologists would be economically and practically unfeasible.

The newly CE-Marked Paige Prostate solution detects cancerous areas and enables pathologists to find these cancerous areas quickly, prospectively improving diagnostic quality and pathologist efficiency in the review of these cases. Additionally, the software can be used for real-time quality review of cases to identify diagnostic discrepancies and thus boost overall quality for a practice.

In a usability study leveraging Paige Prostate and the Insight viewer, Paige found that the technology proved most impactful in the detection of small, well-differentiated foci of cancer, many of which were missed by multiple pathologists. These lesions are difficult to detect and often require further studies at additional expense, such as immunohistochemistry or second opinions.

Paige is excited to announce that with this CE Mark, these first two Paige solutions are ready to be deployed and used in European laboratories and hospitals. For more information about our solutions, please contact [email protected].

About Paige
Based in New York City, Paige was founded in 2017 to serve doctors and patients by revolutionizing cancer diagnosis and treatment with new AI-based technologies that combine pathology, genomics and outcomes data. The company received the first FDA breakthrough designation for an oncology diagnostic and is actively developing several other diagnostic and prognostic products.