Development of molecular assays for non-invasive bladder cancer detection

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DESCRIPTION (provided by applicant): Bladder cancer (BCa) is among the five most common malignancies worldwide. In the US alone, new BCa cases for 2012 are estimated at 73,500 with estimated deaths at 14,880. 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 diagnosis. This recurrence phenomenon makes BCa one of the most prevalent cancers worldwide. Furthermore, once treated, patients are under continued 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 develop assays that can achieve the accurate, non-invasive detection of BCa via urinalysis. Phase I of the project will define optimal combinations of candidate protein biomarkers for the development of a diagnostic signature assay. Using high-throughput genomic and proteomic profiling technologies, we have derived a series of molecular signatures that outperform any currently used urinalysis assay for BCa detection. The specific aim of Phase I is to validate the diagnostic accuracy of components of these signatures using alternative techniques. The goal is to establish the technical and scientific merit of the approach Phase II of the proposal will determine the feasibility of developing selected protein-based and nucleic acid-based molecular signatures into robust assays with clinical utility and commercial value. The strategy will include the following: 1) Test the accuracy of protein signatures defined in Phase I in a large diverse cohort of cases 2) Test the utility of nucleic acid signatures in a large diverse cohort of cases. 3) Derive reagents for inclusion into commercial ELISA and/or point-of-care assays to be developed in Phase III. At the end of the Phase II study, Nonagen Bioscience will be ready to pursue commercialization of one or more assays for the clinical evaluation of at-risk patients for bladder cancer. The development of non- invasive, urine based assays for bladder cancer detection and disease status evaluation will be of tremendous benefit to both patients and the healthcare system.