# Rapid phage-amplified immunoassay for phenotypic UTI diagnosis and antimicrobial susceptibility testing

> **NIH NIH R43** · COBIO DIAGNOSTICS INC. · 2020 · $250,617

## Abstract

Project Summary/Abstract
Urinary tract infections (UTIs) are the most common infection type in the U.S., with around 10.5 million
infections per year equating to a cost of $3 billion. Of significant concern to the healthcare industry, the number
of antibiotic resistant UTIs is increasing at an alarming rate while determining which drugs are effective
remains a significant challenge. Current clinical approaches require 1-3 days or longer, forcing physicians to
treat with broad-spectrum antimicrobials while tests are being performed. Cobio Diagnostics proposes herein
to continue feasibility testing of our phage-based technology that provides ID, AST, and MIC direct-from-
specimen and within 5 hours. Successful development and commercialization of this rapid diagnostic will
reduce testing times, improve treatment, and reduce healthcare costs while conserving effective drugs.
The severity of UTIs, approximately 90% of which are caused by E. coli, range from asymptomatic bacteriuria
to pyelonephritis, which can result in complications including kidney failure and septicemia with significant long
term affects or death. One in three UTIs are sulfamethoxazole/trimethoprim resistant (once the standard
treatment). One in five are resistant to five or more antibiotics with a smaller number now resistant to all
available drugs. Current UTI diagnostic approaches require time-consuming pre-analysis organism
isolation and enrichment and do not provide comprehensive AST/MIC data. The ability to rapidly ID and
assess antibiotic resistance is critical to addressing the emergence of MDR UTIs. Ideally, such a system would
allow actionable same-day ID, AST and MIC direct-from-specimen for multiple drugs without the need for
bacterial isolation or cultivation. Therefore, the overall goal of this multi-phase SBIR project is to leverage our
strong preliminary data to develop, validate and commercialize PhAAST-MIC, Cobio Diagnostics' proprietary
phage-amplified immunoassay, which is a rapid, multiplexed, phenotypic test for bacterial ID, AST and MIC
directly in urine—and ultimately to gain FDA-clearance for the clinical UTI diagnostic routine.
Cobio's expert R&D staff will team with physicians and antibiotic resistance experts at the University of
Colorado and Children's Hospital of Colorado to pursue the Phase I Aims: 1) Develop and characterize unique
anti-coliphage antibodies for incorporation into PhAAST prototypes, 2) Prove the feasibility of PhAAST-MIC E.
coli ID, AST and MIC in urine and 3) Validate PhAAST-MIC direct-from-urine analysis of E. coli UTI specimens
and isolates with comparison to standard-of-care diagnostic practices. Demonstrating rapid and accurate
performance of our technology in representative MDR E. coli positive urine samples will establish the potential
of our novel approach within the limited scope of a Phase I feasibility project, and will set the stage for a larger
Phase II demonstration against other organisms associated with MDR UTIs such ...

## Key facts

- **NIH application ID:** 10138565
- **Project number:** 1R43DK126572-01A1
- **Recipient organization:** COBIO DIAGNOSTICS INC.
- **Principal Investigator:** Christopher R Cox
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $250,617
- **Award type:** 1
- **Project period:** 2020-09-17 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10138565

## Citation

> US National Institutes of Health, RePORTER application 10138565, Rapid phage-amplified immunoassay for phenotypic UTI diagnosis and antimicrobial susceptibility testing (1R43DK126572-01A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10138565. Licensed CC0.

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