Development of molecular assays for non-invasive bladder cancer detection

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$216,710.00
Award Year:
2013
Program:
SBIR
Phase:
Phase I
Contract:
1R44CA173921-01
Award Id:
n/a
Agency Tracking Number:
R44CA173921
Solicitation Year:
2013
Solicitation Topic Code:
NCI
Solicitation Number:
PA12-088
Small Business Information
8833 Perimeter Park Blvd., Jacksonville, FL, 32216-1111
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
68727180
Principal Investigator:
STEVEGOODISON
(904) 521-7393
goodison.steve@gmail.com
Business Contact:
STEVENGOODISON
(407) 266-7401
goodison.steve@gmail.com
Research Institute:
Stub




Abstract
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 tumorsare 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 andproteomic 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 signaturesusing 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 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 forclinical utility.

* information listed above is at the time of submission.

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