By Diagnostics World Staff
November 22, 2022 | University Medical Center (UMC) Utrecht in the Netherlands plans to deploy Paige AI applications for routine clinical use and conduct a clinical health economics study to support the adoption and reimbursement of AI applications in pathology.
The prospective CONFIDENT clinical study will evaluate the performance of the Paige Prostate Suite in a real-world setting. A minimum of 90 patients are expected to be enrolled in CONFIDENT and will receive their standard-of-care diagnosis. Pathologists will use Paige Prostate as part of their existing workflow. The primary endpoint is the impact on the ordering and use of immunohistochemistry (IHC) stains in a prospective clinical setting. CONFIDENT will also evaluate the efficiency of diagnoses when assisted by Paige Prostate. UMC Utrecht and Paige have already begun validation of the software and pathologist validation in addition to aligning with data governance requirements to enable prospective deployment.
Paige Prostate Suite, which draws pathologists’ attention to areas of tissue suspicious of harboring cancer, is comprised of Paige Prostate Detect, Paige Prostate Grade & Quantify, and Paige Prostate Perineural Invasion. Paige Prostate Detect is the only FDA approved AI-powered pathology product available for in vitro diagnostic use.
“UMC Utrecht and Paige share a vision to improve outcomes for patients with cancer and health systems by leveraging quality AI solutions that help standardize the cancer diagnosis process,” said Andy Moye, Ph.D., Chief Executive Officer at Paige, in a press release. “Specifically, this collaboration builds on pioneering work from Utrecht which demonstrated large systemic variability in Gleason scoring of prostate biopsies nationwide in the Netherlands. Paige’s AI software can help overcome these diagnostic challenges. This partnership marks another significant milestone in our efforts to modernize and improve the process of cancer diagnosis globally.”
In early 2016, UMC Utrecht became the first hospital in the Netherlands to digitize its entire pathology workflow. UMC Utrecht currently employs the Sectra Digital Pathology Solution, a vendor-neutral solution for primary diagnostics in its pathology operations. Integration of Paige applications with the Sectra solution is currently underway, and UMC Utrecht may perform additional validation studies using the combined solution.
“As one the earliest adopters of digital pathology workflows, we must continuously demonstrate how these tools can ultimately benefit pathologists, patients and the economics which drive sustainable clinical practices,” said Paul van Diest, M.D., Ph.D., Professor and Head of Pathology at UMC Utrecht and a member of the Scientific Advisory Board at Paige in the same annoucnement. “Having acquired the first-ever FDA clearance for a clinical AI application in pathology, Paige Prostate Detect has cleared the highest bar for quality, and this provides us with confidence as we introduce it into live patient reporting.”
In addition to prostate cancer, Paige and UMC Utrecht plan to evaluate Paige Breast Lymph Node, an AI medical device software that helps pathologists detect if breast cancer has metastasized to lymph nodes, in breast lymph nodes.