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.

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.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
4R44CA173921-02
Application #
8823877
Study Section
Special Emphasis Panel (ZRG1-OTC-H (14))
Program Officer
Lou, Xing-Jian
Project Start
2013-09-06
Project End
2015-02-28
Budget Start
2014-03-01
Budget End
2015-02-28
Support Year
2
Fiscal Year
2014
Total Cost
$901,566
Indirect Cost
Name
Nonagen Bioscience Corporation
Department
Type
DUNS #
068727180
City
Jacksonville
State
FL
Country
United States
Zip Code
32216
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