UroLogic: Rapid, Near-to-Care Identification and Antimicrobial Susceptibility Testing of Microbes in Urine Specimens from Outpatients with Suspected Urinary Tract Infection

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Antibiotic resistance is a global healthcare crisis that is forcing physicians to treat common infectious diseases with ever more potent antibiotics. New diagnostic strategies are urgently needed for rapid pathogen identification/quantification (IDQ) and antimicrobial susceptibility testing (AST) to guide antibiotic selection for patients with urinary tract infection (UTI). MicrobeDx will design and test UroLogic, a highly automated, instrument and cartridge system that performs rapid, accurate pathogen IDQ and AST with turnaround times from sample to readout of 30 and 150 minutes, respectively. While validated, our current assays are manual and require a separate reader. The manual assays 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 can be integrated into an alpha-prototype UroLogic system that meets the diagnostic milestones required for urine specimens to guide therapy for UTI. Aim 1: Evaluation of the Integrated IDQ Assay. We will evaluate the fluidic and analytic performance of the alpha-prototype UroLogic IDQ assay for identification and quantification of bacterial and fungal organisms as isolates and in urine specimens. Results will be compared with standard microbiological biochemical and plating methods. Aim 2: Evaluation of the Integrated AST Assay. We will evaluate the fluidic and analytic performance of the alpha-prototype UroLogic AST assay for antimicrobial susceptibility testing of Gram-negative bacteria as isolates and in urine specimens. Phenotypic methods such as ours are the best predictors of Gram-negative susceptibility. Tests of Feasibility: The alpha prototype system must demonstrate a clinically meaningful LOD (104 cfu/ml) and analytic IDQ and AST accuracy to FDA standards. In addition, the cost of goods device must achieve a price point ($4 IDQ cartridge, $5 AST cartridge, $10,000 instrument) low enough to allow broad dissemination. In future SBIR Phase II studies, additional engineering modifications will be to make this a clinically usable beta-prototype, as informed by feedback from Phase I, and test the entire system in clinical settings. Supported by later Phase IIb funds, we will then evaluate the use of the device in a randomized controlled trial (RCT) to determine analytic accuracy, clinical utility, and healthcare economic impacts.