OmniScreen Prescreening

Paige OmniScreen Prescreening is an AI-driven pre-screening solution developed by Paige, now a Tempus company, designed to bridge the gap between pathology and genomics. By offering a faster, more cost-effective, and tissue-sparing alternative to traditional molecular testing, OmniScreen enables study participant selection, more efficient testing strategies, and streamlined decision-making across both clinical and research settings.

Traditional molecular testing can be costly, time-consuming, and require significant tissue resources. Paige OmniScreen⁺™ addresses these challenges by replicating a targeted biomarker gene panel of 505 genes and predicting over 1,600 biomarkers in minutes, making it a powerful tool for oncology research, drug development, and clinical trial pre-screening.

A Smarter Approach to Molecular Testing

• Accelerate Biomarker Discovery & Research: OmniScreen links phenotypic and genomic patterns, helping to identify new therapeutic targets and optimize biomarker-driven discovery at scale.
• Expedite Patient Enrollment: Quickly pre-screen patients for genomic-related eligibility criteria, limiting molecular testing to only those meeting inclusion criteria, thereby reducing recruitment timelines and costs. High-value cohorts can be identified based on AI-driven biomarker insights.
• Reduce Costs & Conserve Tissue: Narrow down the pool of potential participants to those meeting genomic-related inclusion criteria, preserving finite tissue resources by sending only pre-screened candidates to confirmatory next-generation sequencing (NGS) testing.

Why Use Paige OmniScreen?

• AI-Powered Confidence: Enables scalable biomarker analysis without the need for large datasets or additional tissue samples.
• Optimized for Diverse Applications: Supports oncology research, drug development, and clinical trial pre-screening, while enhancing biomarker-driven discovery, early-phase research, and commercialization strategies.
• Scalable and Ready for Integration: Designed to integrate seamlessly into existing clinical and research workflows across global sites.

Integration into Clinical Trials

Advancing precision medicine requires efficient patient selection, cost-effective molecular profiling, and seamless clinical trial integration. Paige OmniScreen can be integrated into clinical trials in multiple capacities:

• As a pre-screening tool to enhance patient selection
• As a predictive assay for identifying responders versus non-responders
• As an on-label companion diagnostic (CDx) to support regulatory approval pathways

Real-World Application: Clinical Trial Pre-Screening

Paige was the first in the industry to successfully deploy a digital AI biomarker into a clinical trial setting across 90 global sites in collaboration with a leading pharmaceutical partner. Key outcomes from this deployment included:

• Rapid insights: Investigators received results within 1 hour, enabling informed molecular testing decisions.
• A centralized workflow: Digitized whole slide images were transmitted from three contract research organizations (CROs), with AI results shared directly with investigators at individual clinical sites.
• Regulatory compliance: The solution was built under an ISO 13485-compliant Quality Management System.
• Hassle-free integration: Whole slide images were uploaded daily to the Paige platform and the AI analysis was run automatically.

OmniScreen is internally validated as an AI pre-screening mechanism and is designed to integrate into existing digital pathology infrastructure, supporting pharmaceutical partners, clinical research organizations, and healthcare institutions seeking to optimize precision medicine workflows at scale.