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Development of lavage EV protein biomarkers for minimally-invasive detection of endometrial cancer

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43CA272045-01A1
Agency Tracking Number: R43CA272045
Amount: $290,000.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: 102
Solicitation Number: PA21-259
Solicitation Year: 2021
Award Year: 2022
Award Start Date (Proposal Award Date): 2022-09-01
Award End Date (Contract End Date): 2023-08-31
Small Business Information
West Lafayette, IN 47906-4182
United States
DUNS: 965433258
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: Yes
Principal Investigator
 (765) 490-6834
Business Contact
Phone: (765) 490-6834
Research Institution

Early detection of endometrial cancer can increase the 5-year survival rate from lt20% to rt95%.
However, currently there are no non-invasive methods for its detection. We propose the use of
cell-secreted extracellular vesicles (EVs) as the source of new diagnostic biomarkers from uterine
lavage – a sample that is much more targeted to endometrial cancer. Within the scope of biomarker
detection, EVs offer numerous benefits for clinical analysis, including non-invasive collection, a
suitable sample source for longitudinal disease monitoring, higher stability and sample volumes,
faster processing times and lower cost. However, the analysis of exosomes and other EV has not
really been possible for early endometrial cancer detection. The common procedures for biofluid EV
biomarker analysis are very long and cumbersome due to extremely low target levels and high
background of free proteins. In order to enable better biomarker discovery and endometrial cancer
diagnosis, a more reliable and efficient approach is needed, capable of enriching potential
cancer-associated proteins with higher purity. In this NIH SBIR Phase I study, we will implement our
novel method for fast and reproducible enrichment of EVs with rt95% recovery yield and rt99.9%
purity for analysis of endometrial cancer from lavage samples. We have already carried out initial
lavage EV validation and biomarker discovery experiments, and selected over a dozen of
high-quality protein targets that enable effective differentiation of endometrial cancer from
non-cancer controls. The following aims will be completed in the Phase I of the proposal: Aim #1:
Determine the feasibility of the discovered endometrial cancer biomarkers from lavage EVs to
differentiate the disease and refine the panel. Aim #2: Evaluate and implement the novel uterine
lavage collection device for fast and effective EV isolation and measurement. By the completion of
this project, the non-invasive endometrial cancer biomarker discovery platform from lavage EVs will
be developed, and a minimally invasive early endometrial cancer detection assay will be validated
that can overcome the limitations of current approaches, and thus could have an enormous public
health impact and market potential.

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

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