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Integrated Microbial Screening and Antimicrobial Susceptibility Test on Microfluidic Digital Array for Diagnosis of Urinary Tract Infections

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41AI145604-01
Agency Tracking Number: R41AI145604
Amount: $224,658.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIAID
Solicitation Number: PA18-575
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-04-01
Award End Date (Contract End Date): 2020-03-31
Small Business Information
Palo Alto, CA 94306-3638
United States
DUNS: 080013010
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (510) 517-3708
Business Contact
Phone: (415) 890-6885
Research Institution
STANFORD, CA 94305-2004
United States

 Nonprofit College or University

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

* Information listed above is at the time of submission. *

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