# A highly multiplexed convection flow qPCR assay and platform delivering rapid, comprehensive identification and predictive AST of pathogens causing UTIs.

> **NIH NIH R43** · TORUS BIOSYSTEMS, INC. · 2021 · $300,000

## Abstract

Project Summary
Urinary tract infections (UTIs) are among the most prevalent community- and hospital-acquired infections
(~10M annual medical visits), accounting for considerable morbidity and annual US healthcare spend of
greater than $6B. While UTI pathogens are well understood, patients are frequently treated empirically.
The lack of rapid, point of care molecular diagnostics that can identify UTI pathogens results in poor
antimicrobial stewardship and high rates of UTI drug resistance.
We propose to begin development of a rapid diagnostic assay and workflow that will concurrently detect
all UTI pathogens and their associated resistance genes, suitable for point of care clinical applications.
This assay is anticipated to allow for more effective personalized treatment of UTIs, reducing rates of
antimicrobial resistance, and improving patient outcomes.
As described in an upcoming Nature Biomedical Engineering paper, the Torus Biosystems’s qPCR system,
Synestia™, has demonstrated reproducible 30-plex capability, accurate quantitation and SNP detection,
sensitivity down to 10 genomic copies, and turnaround times of less than 30 minutes. The consumable is
equipped with an embedded pre-quenched microarray that allows for real-time detection of amplification
products without opening the reaction chamber. The sensitivity and dynamic range of the Synestia system
has been evaluated across a range of input concentrations of DNA (101 to 105 copies) and the threshold
value was found to be dependent on the log of the input DNA concentration. The platform has also
successfully demonstrated rapid bacteria identification using a multiplex panel specific for 15 bacteria
species.
This Phase 1 application proposes to develop a 60-plex UTI panel for comprehensive assessment of
uropathogen DNA within 30 minutes on the Synestia platform. In the subsequent Phase 2, we will develop,
optimize, and validate a fully integrated consumable including urine sample prep (lysis and extraction) on
the Synestia platform and validate clinical performance in collaboration with select clinical sites. The team
anticipates that the demonstrated assay will constitute a solid basis for further development of a
commercial point of care diagnostic test for urinary tract infections.

## Key facts

- **NIH application ID:** 10322806
- **Project number:** 1R43AI165336-01
- **Recipient organization:** TORUS BIOSYSTEMS, INC.
- **Principal Investigator:** Dmitriy Khodakov
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $300,000
- **Award type:** 1
- **Project period:** 2021-08-01 → 2022-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10322806

## Citation

> US National Institutes of Health, RePORTER application 10322806, A highly multiplexed convection flow qPCR assay and platform delivering rapid, comprehensive identification and predictive AST of pathogens causing UTIs. (1R43AI165336-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10322806. Licensed CC0.

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