Real-World Observational Study of the Clinical Utility of Blood-Based 3D Genome Conformation Mapping (EpiSwitch PSE) to Reduce Unnecessary Biopsies and Augment Patient Management Strategies for Early Prostate Cancer Detection

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Abstract
Prostate cancer (PCa) remains a major contributor to cancer-related morbidity and mortality worldwide. Current diagnostic strategies, largely based on PSA screening, lack specificity and sensitivity, leading to unnecessary invasive procedures and elevated healthcare costs. This real-world study evaluated the EpiSwitch® PSE assay, a blood-based test analyzing 3D genome conformation signatures, in 187 patients undergoing evaluation for PCa. Biopsy confirmation was available for 53 patients, while predictive modeling assessed 134 patients using EpiSwitch PSE results and clinical variables. Across models, up to 79.1% of patients could safely defer biopsy based on PSE results, highlighting the test’s potential to reduce invasive procedures without compromising diagnostic safety. The PSE result, whether high or low, consistently emerged, alongside the PI-RADS score, as the strongest predictor of cancer risk, highlighting the PSE score as the primary driver of this outcome. Incorporating the EpiSwitch PSE assay into clinical workflows enhances decision-making efficiency, reduces unnecessary biopsies, and improves healthcare resource utilization. These findings support the assay’s strong clinical utility and economic value, highlighting its potential for broader adoption as a minimally invasive reflex test and a pre-biopsy triage tool for prostate cancer early and accurate detection.

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