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

> **NIH NIH R43** · TYMORA ANALYTICAL OPERATIONS, LLC · 2022 · $290,000

## Abstract

PROJECT SUMMARY
Early detection of endometrial cancer can increase the 5-year survival rate from <20% to >95%.
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 >95% recovery yield and >99.9%
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.

## Key facts

- **NIH application ID:** 10540917
- **Project number:** 1R43CA272045-01A1
- **Recipient organization:** TYMORA ANALYTICAL OPERATIONS, LLC
- **Principal Investigator:** Anton Iliuk
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $290,000
- **Award type:** 1
- **Project period:** 2022-09-01 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10540917

## Citation

> US National Institutes of Health, RePORTER application 10540917, Development of lavage EV protein biomarkers for minimally-invasive detection of endometrial cancer (1R43CA272045-01A1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10540917. Licensed CC0.

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