Translation of a Clinical Molecular Diagnostic Assay for Bladder Cancer

项目摘要/摘要 膀胱癌(BCA)是美国和全世界最常见的五种恶性肿瘤之一。在演讲中， 大多数膀胱肿瘤是非肌肉侵袭性的，可以通过经尿道电切术治疗。 肿瘤；然而，超过70%的BCA患者在治疗后的头两年内会复发 初级治疗。这种复发现象使BCA成为世界上最常见的癌症之一。 因此，一旦确诊，患者将持续接受常规膀胱镜检查，以检测 新的肿瘤开发，所以BCA的医疗成本是一个主要负担。这个项目的总体目标是 调整和优化一种有效的检测方法，以实现BCA的准确、无创检测 尿检。 使用高通量蛋白质组图谱技术和多项验证研究，我们定义了一种 多重蛋白质生物标志物签名，性能优于目前使用的任何非侵入性BCA方法 侦测。下一步的任务是开发特定的技术体系，并通过优化实现 用于临床分子诊断的新检测方法的翻译。为了解决这个问题，我们创建了一个 梅奥诊所和中尺度诊断公司之间的学术/行业研究伙伴关系。这项建议 将在真实世界中测试功能、启用优化并验证所提议的检测的性能 临床实验室设置。在研究结束时，我们的目标是开发一种非侵入性的、基于尿液的 用于膀胱癌检测和疾病状态评估的分析将对双方都有巨大的好处 病人和医疗保健系统。

Project Summary/Abstract Bladder cancer (BCa) is among the five most common malignancies in the US and worldwide. At presentation, the majority of bladder tumors are non-muscle invasive and can be treated by transurethral resection of the tumor; however, more than 70% of patients with BCa will have a recurrence during the first two years after primary treatment. This recurrence phenomenon makes BCa one of the most prevalent cancers worldwide. Accordingly, once diagnosed, patients are under continual surveillance with routine cystoscopy for detection of new tumor development, so the healthcare costs of BCa are a major burden. The overall goal of this project is to adapt and optimize an efficient assay that can achieve the accurate, non-invasive detection of BCa via urinalysis. Using high-throughput proteomic profiling technologies and multiple validation studies, we have defined a multiplex protein biomarker signature that outperforms any currently used non-invasive approach for BCa detection. The next task is to develop a specific technology system and achieve through optimization the translation of the novel assay for clinical molecular diagnosis. To address this, we have created an academic/industry research partnership between the Mayo Clinic and Meso Scale Diagnostics. The proposal will test functionality, enable optimization, and validate the performance of the proposed assay in a real-world clinical laboratory setting. At the end of the study, we aim to have developed a non-invasive, urine-based assay for bladder cancer detection and disease status evaluation that will be of tremendous benefit to both patients and the healthcare system.