Background/Objectives: 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, ability to avoid unnecessary biopsies and the resulting clinical and economical benefits.Methods: 187 patients undergoing evaluation for PCa were tested with the EpiSwitch®PSE assay. Biopsy confirmation was available for 53 patients, while predictive modeling assessed 134 patients using EpiSwitch PSE results and clinical variables.Results: Among the 187 patients evaluated, predictive modeling showed that up to 79.1% (106/134) of patients could safely defer biopsy based on a low-likelihood EpiSwitch PSE result, while an alternative model showed a 66.4% (89/134) biopsy avoidance rate. The PSE result demonstrated strong concordance with biopsy-confirmed diagnoses and was the most influential predictor in multivariate analysis, followed by PI-RADS score. The test achieved a 100% technical success rate, with an average turnaround time of 4.4 days.Conclusions: 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 the early and accurate detection of prostate cancer. Future studies should include prospective, multicenter trials to confirm these results across broader populations and evaluate longitudinal outcomes of patients managed with PSE-guided care.
背景/目的：前列腺癌（PCa）仍是全球癌症相关发病率和死亡率的主要因素。当前主要基于PSA筛查的诊断策略缺乏特异性和敏感性，导致不必要的侵入性操作和医疗成本上升。这项真实世界研究评估了EpiSwitch®PSE检测——一种通过分析三维基因组构象特征的血浆检测方法——在避免不必要活检方面的能力及其带来的临床与经济效益。 方法：对187名接受前列腺癌评估的患者进行EpiSwitch®PSE检测。其中53名患者获得活检确诊结果，134名患者通过EpiSwitch PSE检测结果结合临床变量进行预测模型评估。 结果：在评估的187名患者中，预测模型显示基于低风险EpiSwitch PSE结果，高达79.1%（106/134）的患者可安全推迟活检；另一模型显示活检避免率达66.4%（89/134）。PSE检测结果与活检确诊诊断高度一致，在多变量分析中成为最具影响力的预测因子，其次为PI-RADS评分。该检测技术成功率达100%，平均报告周期为4.4天。 结论：将EpiSwitch PSE检测纳入临床工作流程可提升决策效率、减少不必要活检并优化医疗资源配置。这些发现证实了该检测具有显著的临床实用性和经济价值，凸显其作为微创反射检测及活检前分诊工具在前列腺癌早期精准检测中的广泛应用潜力。未来研究需开展前瞻性多中心试验，以在更广泛人群中验证结果，并评估PSE指导下的患者长期管理结局。
EpiSwitch PSE Blood Test Reduces Unnecessary Prostate Biopsies: A Real-World Clinical Utility Study
肿瘤(癌症)患者之家