CNine Biosolutions — Department of Health and Human Services SBIR Phase I: NIAID

Description

The objective of this Phase I application is to develop and assess a sMAC lateral flow assay diagnostic tool for bacterial meningitisBMDevelopment of rapidhighly sensitive and specific clinical diagnostic for bacterial infections in the central nervous systemCNSsuch as BM and shunt infectionthat are easy to use and cost effectivewould significantly improve healthcare in the US and worldwideWe have identified the biomarkersoluble membrane attack complexsMACthataccurately diagnoses CNS infectionprovides prognostic value in follow up testingandhas potential value in monitoring patients undergoing therapeutic treatment to block complement activation and thus the formation of sMACBacterial infections in the CNS are a life threatening condition requiring rapid diagnosis and appropriate treatment to reduce morbidity and prevent mortalityMillions of individuals in the North AmericaEurope and Asia undergo lumbar puncture every year on suspicion of bacterial meningitisIn sub Saharan Africabacterial meningitis is a significant health threat killing tens of thousands annuallyThe lack of sufficiently trained medical personnel and laboratory resources limits diagnostic capability and corresponding treatment in this regionAdditionallyBM frequently occurs in children treated with cerebrospinal fluidCSFshunts to manage hydrocephalusAssociated health expenditures are estimated to cost $billion per year in the USAand shunt failure rates remain high as assessed in a recent international study which documentedday andyear shunt failure rates ofandrespectivelyMethods to diagnose BMare time consumingnot always specificand can be expensiveBacterial culturingthe gold standard for diagnosishas a significant false negative ratewhile testing for changes in CSF proteinglucose levelsand white blood cell infiltrationWBCare generally inconclusiveThese tests can be augmented with expensive and technical PCR and imaging techniquesDifferential diagnosis for meningitis remains challenging despite these advancesand is difficult in resource poor settings where other neurological diseases can complicate diagnosisSuccessful completion of this assay will solve many problems associated with the current gold standard test by significantly reducing time to test resultsincrease sensitivityand reduce clinical lab expenses