All on the Same Page
FDA marketing authorization of Paige Prostate software brings heightened confidence and peace of mind to pathologists
sponsored by Paige
Pathology must modernize to meet the twin challenges of rising workload and falling numbers of pathologists – but how can laboratories with limited personnel manage the projected 60 percent increase in cancer cases? One answer is to boost workflow capacity and efficiency by adopting artificial intelligence (AI)-based technologies, which will also improve the quality of diagnosis by generating detailed information to support personalized treatment recommendations.
Paige’s computational technology – created by pathologists for pathologists – meets these real-world needs. Its flagship product, Paige Prostate, is the first AI-based pathology product to receive de novo approval from the FDA, allowing in vitro diagnostic use via FullFocus™ – an FDA-cleared, CE-marked viewing software compatible with most existing digital pathology solutions. In a clinical study submitted to the FDA, pathologists using Paige Prostate exhibited a 7 percent sensitivity increase in correctly diagnosing cancer, a 70 percent reduction in false negative diagnoses, and a 24 percent reduction in false positive diagnoses. This improvement was independent of pathologists’ diagnostic subspecialization or years of experience, and whether the analysis was done remotely or on-site. Proven to improve diagnostic accuracy, Paige Prostate can help pathologists reduce detection errors and boost workflow efficiency.
In Europe, Paige’s AI-based capabilities include two CE-marked tools: i) Paige Prostate, which detects foci of prostate cancer, assesses primary and secondary Gleason patterns, and measures tumor percentage and linear extent; and ii) Paige Breast, which assists with detection of premalignant and malignant breast neoplasms.
Ultimately, Paige’s clinical-grade, AI-enabled computational technologies constitute a complete and fully FDA-cleared solution that enables pathologists to work more efficiently – pairing AIbased digital diagnostics with a broadly compatible imaging platform. With Paige Prostate, pathologists can review cases with heightened confidence and peace of mind. With FullFocus, pathologists can collaborate and review cases remotely, prioritize cases efficiently, and make diagnoses with increased speed and precision. By identifying easily overlooked diagnostic signals, Paige’s technologies improve clinical confidence and accelerate the pathology workflow. Unsurprising, then, that Paige’s software is associated with high levels of user satisfaction. The low-cost, easy-to-adopt software tools increase workflow capacity and accuracy – optimizing diagnosis and analysis in prostate and breast cancer case review.
Better Together: Paige Prostate and FullFocus Advantages
• easy adoption: no IT hardware required; intuitive AI interface throughout the workflow
• immediate availability of AI results
• compatible with most laboratory information systems and scanner platforms
• permit simultaneous comparison of multiple slides
• secure, remote access permits location-independent case review, diagnosis, sign-out, and report submission