Development of molecular assays for non-invasive bladder cancer detection

DESCRIPTION provided by applicant Bladder cancer BCa is among the five most common malignancies worldwide In the US alone new BCa cases for are estimated at with estimated deaths at At presentation the majority of bladder tumors are non muscle invasive and can be treated by transurethral resection of the tumor however more than 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 Test the accuracy of protein signatures defined in Phase I in a large diverse cohort of cases Test the utility of nucleic acid signatures in a large diverse cohort of cases 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 PUBLIC HEALTH RELEVANCE Bladder cancer is one of the most prevalent cancers in the world due partly to its persistent recurrence after initial treatment The development of accurate assays that can detect and monitor bladder cancer non invasively through urine analysis would be a major advance over current modalities and would benefit both patients and healthcare systems The goal of this project is to develop diagnostic assays for bladder cancer that can be commercialized for clinical utility