# Early Detection of Ovarian Cancer Using Uterine Lavage and Duplex Sequencing

> **NIH NIH R44** · TWINSTRAND BIOSCIENCES, INC. · 2020 · $221,887

## Abstract

Nearly a quarter of a million new cases of ovarian cancer are identified every year worldwide and the majority
of these woman will die from their disease. When detected early, surgical cure rates exceed 90%, but currently
most cases are detected at an advanced stage when the cancer has already disseminated. As such, our most
pressing problem in ovarian cancer is a lack of tools to identify early stage disease when resection plus
chemotherapy can achieve a complete cure. Clinical early detection poses a significant challenge because
symptoms are often few and vague. Several imaging and molecular approaches have been developed but, as-of-
yet, no screening method has ever performed well enough to prevent deaths, so none are currently
guideline-recommended, nor FDA approved. An urgent, unmet need remains. In this proposal we outline a
plan to develop, and bring to market within 3 years, an innovative early detection product, which we believe will
be the first ever ovarian cancer screening tool with sufficient sensitivity and specificity to save lives and to
become a routine part of preventative care. The test is based on a minimally-invasive uterine lavage device
and five-minute clinic procedure to sample DNA shed by ovarian tumors into the fallopian tubes and uterine
cavity. The collected sample is then analyzed by Duplex Sequencing, the most accurate DNA sequencing
technology in existence, to detect the low-level signature of tumor-derived mutations to infer the presence or
absence of cancer. Members of our team pioneered each of these proprietary technologies; the premise and
feasibility of the combined diagnostic are supported by strong preliminary studies. In Phase I of this Fast Track
application we will further refine steps in our collection and sequencing procedures to facilitate industrial-scale
deployment and will formally validate analytical performance. In Phase II we will carry out two parallel case-control
studies on distinct, but equally important populations. In Aim 1 we will focus on average risk women,
who encompass a potential unmet market of more than fifty million in the US alone. In a large cohort we will
validate diagnostic performance and clinical utility, with a focus on maximizing sensitivity and specificity
through rigorous statistical modeling and covariate adjustment. In Aim 2 we will repeat this process, but for
women with a heritable ovarian cancer-predisposing condition, with the specific emphasis on identifying
extremely early stage tumors. The final product to be delivered will be a robust, cost effective and practically
implementable Laboratory Developed Test (LDT) ready for commercial deployment. Ovarian cancer regularly
takes the lives of thousands of women among us; we fundamentally believe this is unnecessary, unacceptable
and something that our team and technology is positioned better than any other in the world to begin changing.

## Key facts

- **NIH application ID:** 10009277
- **Project number:** 5R44CA221426-04
- **Recipient organization:** TWINSTRAND BIOSCIENCES, INC.
- **Principal Investigator:** Jesse J Salk
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $221,887
- **Award type:** 5
- **Project period:** 2018-09-14 → 2021-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10009277

## Citation

> US National Institutes of Health, RePORTER application 10009277, Early Detection of Ovarian Cancer Using Uterine Lavage and Duplex Sequencing (5R44CA221426-04). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10009277. Licensed CC0.

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