Urologic: Rapid; Near-to-care Identification and Antimicrobial Susceptibility Testing of Microbes in Urine Specimens From Outpatients With Suspected Urinary Tract Infection

Antibiotic resistance is a global healthcare crisis that is forcing physicians to treat commoninfectious diseases with ever more potent antibiotics. New diagnostic strategies are urgentlyneeded for rapid pathogen identification/quantification (IDQ) and antimicrobial susceptibilitytesting (AST) to guide antibiotic selection for patients with urinary tract infection (UTI).MicrobeDx will design and test UroLogic, a highly automated, instrument and cartridgesystem that performs rapid, accurate pathogen IDQ and AST with turnaround times fromsample to readout of 30 and 150 minutes, respectively.While validated, our current assays are manual and require a separate reader. The manualassays have delivered high sensitivity and specificity. We are developing a fully automated,near-to-care assay system that is affordable for clinics and conventional primary care offices.In Phase I, our Specific Aims are proof-of-concept validation that the IDQ and AST assays canbe integrated into an alpha-prototype UroLogic system that meets the diagnostic milestonesrequired for urine specimens to guide therapy for UTI.Aim 1: Evaluation of the Integrated IDQ Assay. We will evaluate the fluidic and analyticperformance of the alpha-prototype UroLogic IDQ assay for identification and quantification ofbacterial and fungal organisms as isolates and in urine specimens. Results will be comparedwith standard microbiological biochemical and plating methods.Aim 2: Evaluation of the Integrated AST Assay. We will evaluate the fluidic and analyticperformance of the alpha-prototype UroLogic AST assay for antimicrobial susceptibility testingof Gram-negative bacteria as isolates and in urine specimens. Phenotypic methods such asours are the best predictors of Gram-negative susceptibility.Tests of Feasibility: The alpha prototype system must demonstrate a clinically meaningfulLOD (104 cfu/ml) and analytic IDQ and AST accuracy to FDA standards. In addition, the cost ofgoods device must achieve a price point ($4 IDQ cartridge, $5 AST cartridge, $10,000instrument) low enough to allow broad dissemination.In future SBIR Phase II studies, additional engineering modifications will be to make this aclinically usable beta-prototype, as informed by feedback from Phase I, and test the entiresystem in clinical settings. Supported by later Phase IIb funds, we will then evaluate the use ofthe device in a randomized controlled trial (RCT) to determine analytic accuracy, clinical utility,and healthcare economic impacts.