Developing a desktop instrument that can diagnose urinary tract infections and suggest treatment in 60 minutes 

Project title: InnotiveDx novel UTI diagnostic system prototype optimisation and first clinical use 

Existing diagnostic approaches for urinary tract infections (UTIs) include indicator dip sticks, which provide rapid results, but are limited in their accuracy and do not identify the causative pathogens or test their susceptibility to antibiotics. Laboratory-based urine cultures do offer higher accuracy, alongside specific pathogen identification and susceptibility data, but take 2–3 days from sample to result. A more reliable, faster diagnosis method is needed, both to ensure optimum treatment and to reduce the risk of antimicrobial resistance. 

To address this need, InnotiveDx is developing a diagnostic platform for use in primary care that can identify the UTI-causing pathogen within 10 minutes and recommend an appropriate antibiotic within 60 minutes. A single-use cartridge containing the patient’s urine is placed into a small desktop instrument designed specifically for a primary care setting. The sample is divided between 18 chambers, and the bacteria are automatically imaged, firstly to identify them by their response to fluorescent dyes, and secondly to monitor whether they grow or die in the presence of various antibiotics, which would indicate susceptibility. 

Using a lab-based assay, the test has been found to have >96% accuracy, and InnotiveDx is currently in the process of developing this into a single-use cartridge format alongside a prototype analyser. Funding and support from PACE will allow InnotiveDx to optimise its first integrated prototypes and then generate crucial data through in-house testing. Following this, real-world performance will be demonstrated as part of the TOUCAN study, which will also provide data on the platform’s cost-effectiveness. 

Success for the project will mean delivery of a cartridge design ready for manufacture and regulatory testing. Ultimately, patients will benefit by on-the-spot diagnosis of bacterial UTIs, and rapid selection of an optimum antibiotic, improving health outcomes and reducing the risk of antimicrobial resistance.

Company Summary

InnotiveDx is developing a point of care diagnostic system capable of precisely identifying the bacterial organism causing an infection and its      antibiotic susceptibility within an unprecedented 60 minutes. 

InnotiveDx’s technology is based on single cell observation of bacteria. InnotiveDx’s initial target is to improve diagnosis in uncomplicated urinary tract infections (uUTI), before seeking to expand into other bacterial infections. InnotiveDx spun out of the University of Liverpool in 2021.