Specific Diagnostics, Inc. — Department of Health and Human Services SBIR Phase II: NIAID

Description

Project Summary Antibiotic resistance has recently emerged as a global threat for healthcare systemsAn increasing number of pathogenic bacteria are acquiring antibiotic resistanceand new forms of resistance are continuously emerging with alarming speed across international boundariesIn the USalonethe Center for Disease Control and PreventionCDChas estimatedmillion patients per year are directly affected by antibiotic resistant pathogensleading to more thandeathsProviding rapiddefinitive and cost effective antibiotic susceptibility testingASTwill be of increasingly vital importance in controlling this burgeoning problemWhile legacy methods generally require overnight culturingthe time urgency of determining effective antibiotics has prompted a push for rapid AST that can perform in a few hoursUnfortunatelysome of the newest rapid AST instruments are either not suited to multiplexingor are an order of magnitude more costly than legacy methodsdiscouraging their widespread useA rapid multiplexed AST platform that provides minimum inhibitory concentrationsMICswithin hours at comparable cost to current methods will enable rapid determination of effective targeted therapyresulting in short hospital stays and fewer additional laboratory testsand decreasing morbidity and mortality along with associated healthcare expensesSpecific Technologies has introduced and with NIAID support commercially developed a culture system that combines detection with organism IDUsing a printed array of chemically responsive colorimetric indicators introduced into culture headspacethe species specific pattern of volatiles emitted during growth produce a species specific patternwhich we have shown to reduce detection time and enable Gram status and species ID to be determined hands free during cultureHerewe present data showing that the use of this system can be extended to very rapidlyorderhourascertain phenotypic antibiotic susceptibilityThe preliminary data demonstrate that introduction of antibiotic to positive blood culture prompts a susceptibility dependent and antibiotic concentration dependent shift in volatile sensor response within andltminutesRecognizing that a commercial AST instrument must be multi wellwe have performed pilot study in which the positive sample is removed from a blood culture bottle and divided into a multi chamber settingin which even at pilot study stage we demonstrate a andlthrs phenotypic ASTmeasuring values matching the results of the CLIA compliant Sensititre gold standardMoreoverthe disposable is inherently low costas it only depends upon an inexpensive printed sheet of CSA sFinallynot only is this method intrinsically low cost but low skill compatibleas there is no sample preparation from positive blood cultureIt is thus very well suited for bothhour day developed world labswhere it will speed time to answeras well as the low skill environments of the developing worldIn this direct to Phase II applicationwe propose to use our CSA technology to systematically quantifyand validate the parameter dependence of this system and then engineer and produce a benchtop instrument suitable for preclinical and clinical testingwhich will provide a low costhighly automated multiplexed phenotypic susceptibility determination directly from a positive blood sample in less thanminutesWe propose to develop and commercialize an instrument that integrates our rapid AST capability with our Specblood culture and species ID system that is being commercialized nowoffering a uniquely streamlined and low cost system with by far the fastest yet proposed time from patient sample to detectionID and phenotypic multiplexed quantitative AST Project Narrative The proposed research effort will develop and commercialize an instrument that integrates our rapid AST capability with our blood culture and species ID systemSpecthat is being commercialized nowoffering a uniquely streamlined and low cost system with by far the fastest yet proposed time from patient sample to detectionID and phenotypic multiplexed quantitative AST