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

Description

Project Summary Abstract TuberculosisTBis one of the leading causes of morbidity and mortality from infectious disease worldwide with an estimatedmillion cases of active TB andmillion deaths from the disease annuallyDespite emerging new technologiesculture remains the gold standard in TB diagnosis and therapeutic monitoringInthe World Health OrganizationWHOrecommended the use of a liquid culturing system using the Mycobacteria Growth Indicator TubeMGITand drug susceptibility testDSTin middle and low income countries to address challenges due to the high prevalence of HIV co infection and drug resistant TBWhile automated liquid culture systems can detect the presence of mycobacteriathey do not furnish species level identificationrequiring separate identification tests for positive samplesSpecific Technologies has a novel sensor technology that can be easily adapted into an existing liquid culture system to not only detect the presence of mycobacteriabut also to provide species and strain identificationIn collaboration with the Stanford University School of MedicineSpecific Technologies has demonstrated the colorimetric sensor array s ability to detect and identify thatclinically relevant bacterial species in blood culture withaccuracy overtrialsThe CSA also allowed discrimination between unrelated strains of methicillin resistant Staphylococcus aureusindicating that the metabolomic fingerprint can differentiate different strains of the same speciesRecentlythese results have been extended to demonstrate the use of CSA sensors for the characterization ofmycobacterial species in liquid cultureHerewe propose to further develop and commercially validate this inexpensivesimple and novel sensing paradigm for mycobacterial culturecombining improved speed to detection with the hands free species IDThe strain level signature we have demonstrated could have profound value for obtaining putative susceptibility profilesand epidemiologically tracking resistant strains in the low resource environments characteristic of TB infection Project Narrative The proposed research effort will integrate the colorimetric sensor array technology into an automated mycobacterial liquid culture systemThe proposed effortif successfulwill yield a rapid culture system with the capacity to obtain a species and strain identification without any additional sample manipulation