Translation of a Clinical Molecular Diagnostic Assay for Bladder Cancer

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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.