Combinati Incorporated — Department of Health and Human Services STTR Phase I: NIAID

Description

Abstract COMBiNATi will work with Stanford University to bring the world s first integrated ID AST UTI diagnostic platform to the market by combining COMBiNATi sone clickcost effective dPCR platform with Stanford s pathogen identificationIDHRMA algorithm for broad detectiondeep characterization and absolute quantification of UTI pathogensBy the end of the Phaseprojectwe will deliver the prototype instrument for ID and ASTscale ready consumables for dPCRHRM and cultureqPCRmachine learning software algorithm for melt curve analysisand prove the feasibility by identifying and quantifying the top two urinary tract infection bacteriaWe will first develop two consumablesank partition ID chip and alanek partition per lane AST plate based on the micro injection molding design rules established by COMBiNATiAn integrated system with thermal control and imaging capability will then be developed for HRM and qPCR processesThe prototype system will then be transferred to Stanford University where mock samples including both isolated bacteria and contrived urine samples will be tested on the platform for integrated pathogen ID and AST determination Narrative Urinary Tract InfectionUTIis one of the most common community acquired bacterial infectionHoweverlike other bacterial infectionsstandard culture based diagnosis of UTI requires at leastdays from sample acquisition to result reportingDespite technological advancementsthe process remains timeconsuming and requires significant technical expertiseAutomated instruments remain bulky and still require clonal isolation of the pathogens from the body fluid samples prior to ASTAdditionallythe lack of definitive microbiological diagnosis that is rapid enough to achieve evidence based treatment has driven the overand misuse of broad spectrum antibioticsWe believe the proposed integrated IDAST platform has the potential to enable deep genetic analyses of clinical samples to provide rapid precision UTI triage and MIC determination in a timely and cost efficient manner to positively impact patient care as well as promote the use of narrow spectrum antibiotics to favorably impact antibiotic resistance profiles