# PA21-259, SBIR, Phase I, POC detection of chlamydia and gonorrhea small RNAs using a target reporter construct assay by lateral flow in urine surrogates

> **NIH ALLCDC R43** · REDVAULT BIOSCIENCES, LP · 2022 · $299,928

## Abstract

Project Summary
Worldwide, more than one million sexually transmitted infections (STIs) are acquired daily. Chlamydia
trachomatis (C. trachomatis) and Neisseria gonorrhoeae (N. gonorrhoeae) are two such pathogens that show
the greatest incidence of sexually transmitted disease (STD). If untreated, both chlamydia and gonorrhea can
lead to serious health and reproductive issues, and yet, both are often asymptomatic in many infected individuals.
The Centers of Disease Control and Prevention (CDC) and World Health Organization (WHO) strongly
recommend routine screening of both men and woman. Several recent studies have also suggested the need
for rapid point-of-care (POC) tests as most patients in the developed world are willing to wait only 20-30 minutes
for results in the clinic. The advantages of a low cost, accurate, and true POC assay based on nucleic acid
amplification for the detection of C. trachomatis and N. gonorrhoeae could facilitate early detection, thus
potentially reducing transmission and sequelae, as well as improve therapeutic outcomes in the clinic. Beyond
this setting, successful demonstration of such a rapid test could be expanded into the home-use market.
RedVault Biosciences (RVB) has previously been awarded a Phase I grant (R43 CA200398-01A1) for its
isothermal Target Reporter Construct (TRC) technology utilizing small RNAs, such as microRNAs. Here, RVB
will develop a simple use, lateral flow (LF) test strip assay based on RVB’s proprietary TRC assay. Small RNAs
(sRNAs) from C. trachomatis and N. gonorrhoeae will be used as targets with high specificity. By design, such
sRNAs can be used as a primer of DNA replication in the TRC assay and not as the template traditionally used
in nucleic acids amplification tests (NAATs). This novel utility of the target sample in a TRC assay simplifies
library preparation and is well-suited for development of a POC test. To achieve these goals, three specific aims
are proposed 1) determine the presence of bacterial sRNAs in clinical urine samples that have tested positive
for C. trachomatis and N. gonorrhoeae, 2) develop a lateral flow test with RVB’s TRC technology, and 3)
demonstrate feasibility with the test. Upon success with these goals, Phase II will include development of an
integrated workflow that brings the steps of sRNA isolation, TRC CT/NG reaction, and LF detection into a simple,
integrated POC device for the analysis of clinical samples.

## Key facts

- **NIH application ID:** 10480246
- **Project number:** 1R43PS005272-01
- **Recipient organization:** REDVAULT BIOSCIENCES, LP
- **Principal Investigator:** Michael L. Metzker
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** ALLCDC
- **Fiscal year:** 2022
- **Award amount:** $299,928
- **Award type:** 1
- **Project period:** 2023-09-30 → 2024-09-29

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10480246

## Citation

> US National Institutes of Health, RePORTER application 10480246, PA21-259, SBIR, Phase I, POC detection of chlamydia and gonorrhea small RNAs using a target reporter construct assay by lateral flow in urine surrogates (1R43PS005272-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10480246. Licensed CC0.

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