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Development of non-invasive biomarker discovery and diagnostics approach for bladder cancer based on urine proteome and phosphoproteome

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 4R44CA239845-02
Agency Tracking Number: R44CA239845
Amount: $1,300,000.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: 102
Solicitation Number: PA18-574
Solicitation Year: 2018
Award Year: 2020
Award Start Date (Proposal Award Date): 2020-09-01
Award End Date (Contract End Date): 2022-08-31
Small Business Information
West Lafayette, IN 47906-4182
United States
DUNS: 965433258
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (765) 490-6834
Business Contact
Phone: (765) 490-6834
Research Institution

Profiling of Extracellular Vesicles (EV) has emerged as a highly promising field for discovery of
tumor-relevant biomarkers from biofluids, such as blood, urine, CSF or others. The use of biofluid
EVs offers numerous advantages in clinical setting, including non-invasive collection, a suitable
sample source for longitudinal disease monitoring, better screenshot of tumor heterogeneity, higher
stability and sample volumes, faster processing times, lower rejection rates and costs compared to
their tissue counterpart. Despite the immense potential, the data on EV phosphoproteomes are
virtually non-existent. In this NIH SBIR Fast-Track study, we will further develop a novel urine
analysis platform based on EVtrap beads for complete capture of extracellular vesicles and in-house
developed proteome extraction and analysis approach into highly efficient and reproducible method
for discovery and detection of cancer biomarkers. We have already utilized this approach to generate
a new panel of protein/phosphoprotein markers from urinary EVs for sensitive and non-invasive
detection and monitoring of bladder cancer. During this project, the discovered biomarkers panel will
be validated and refined to demonstrate clinical utility. The following aims will be completed in the
Phase I of the proposal: Aim #1: Develop and optimize EVtrap for large-scale and high-throughput
EV isolation. Aim #2: Determine the feasibility of the current bladder cancer biomarkers and refine
the panel. The following aims will be completed in the Phase II of the proposal: Aim #1: Adapt EVtrap
to an existing automated device for high-throughput EV capture and cargo analysis. Aim #2: Validate
and standardize the final panel for clinical utility. By the completion of this project, a biomarker
discovery platform from urine will be developed, and bladder cancer monitoring assay will be
validated that can overcome the limitations of current approaches, and thus could have an enormous
public health impact and market potential.PROJECT NARRATIVE
Protein phosphorylation relates to the onset and development of many cancer types
and a highly efficient technology for phosphorylation analysis is critical for cancer
research. This NIH SBIR Fast-Track project will support the effort to develop an
innovative protein/phosphoprotein biomarker discovery and detection platform from
urine, with particular focus on bladder cancer diagnostics.

* Information listed above is at the time of submission. *

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