MicrobeDx, Inc. — Department of Health and Human Services SBIR Phase I: NIAID

Description

Antibiotic resistance is a global healthcare crisis that is forcing physicians to treat common infectious diseases with ever more potent antibioticsNew diagnostic strategies are urgently needed for rapid pathogen identification quantificationIDQand antimicrobial susceptibility testingASTto guide antibiotic selection for patients with urinary tract infectionUTIMicrobeDx will design and test UroLogica highly automatedinstrument and cartridge system that performs rapidaccurate pathogen IDQ and AST with turnaround times from sample to readout ofandminutesrespectivelyWhile validatedour current assays are manual and require a separate readerThe manual assays have delivered high sensitivity and specificityWe are developing a fully automatednear to care assay system that is affordable for clinics and conventional primary care officesIn Phase Iour 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 UTIAimEvaluation of the Integrated IDQ AssayWe 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 specimensResults will be compared with standard microbiological biochemical and plating methodsAimEvaluation of the Integrated AST AssayWe 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 specimensPhenotypic methods such as ours are the best predictors of Gram negative susceptibilityTests of FeasibilityThe alpha prototype system must demonstrate a clinically meaningful LODcfu mland analytic IDQ and AST accuracy to FDA standardsIn additionthe cost of goods device must achieve a price point$IDQ cartridge$AST cartridge$instrumentlow enough to allow broad disseminationIn future SBIR Phase II studiesadditional engineering modifications will be to make this a clinically usable beta prototypeas informed by feedback from Phase Iand test the entire system in clinical settingsSupported by later Phase IIb fundswe will then evaluate the use of the device in a randomized controlled trialRCTto determine analytic accuracyclinical utilityand healthcare economic impacts Antibiotic resistance is a global healthcare crisis that is forcing physicians to treat common infectious diseases with ever more potent antibioticsNew diagnostic strategies are urgently needed for rapid pathogen identification quantificationIDQand antimicrobial susceptibility testingASTto guide antibiotic selection for patients with urinary tract infectionMicrobeDx will design and test UroLogica highly automated instrument and cartridge system that performs rapidaccurate pathogen IDQ and AST with turnaround times from sample to readout ofandminutesrespectively