BAEBIES, INC. — Department of Health and Human Services SBIR Phase II: NIDCD

Description

ABSTRACTRapidNear Patient Nucleic Acid Testing for Congenital CytomegalovirusCMVInfectionPADirect to Phase IIUniversal newborn hearing screening is mandated in the United States and is performed in the postpartum hospital settingCurrent physiology based hearing tests are unable to detect late onset infantile hearing loss caused by congenital cytomegalovirusCMVinfectionAntiviral treatment can ameliorate CMV associated infant hearing loss if initiated quickly after birtha complementary screening approach has therefore been suggested to identify newborns with congenital CMV infection in order to facilitate early detection and intervention and prevent CMV related hearing loss and developmental delaysA nucleic acid test has been described to screen newborns for congenital CMV infection using saliva specimens that is more sensitive than the dried blood spots traditionally used by the newborn screening laboratoriesDespite the existence of such a testpublic newborn screening programs do not have the infrastructure necessary to test newborn saliva samplesBaebiesmission is to save the lives of newborns by bringing new tests to newborn screeningTo address the current challenges to implementing CMV screeningBaebies developed and successfully tested a nucleic acid assay for CMV on a laboratory based digital microfluidic platformTo bypass the limitations inherent to newborn screening laboratories and bring this assay to hospitals and birthing centerswe will add functionality to our near patient testing instrument to enable single sample molecular testing via PCRWe previously designed an on cartridge PCR assay to test for CMV by fully integrating sample preparation and PCR on the same cartridge for the detection of CMV using digital microfluidic technologyWith this assaywe are able to detect as few ascopies of CMV inLOur system was challenged withde identified and archived saliva samplesthese samples and the results were compared to the standard PCR assay for CMVWe successfully detectedpositive CMV samplesWe improved the sensitivity of the assay and again challenged our system withprospectively collected saliva samples from newborns born at the University of Alabama at BirminghamUABall the samples were identified correctlyIn this Direct to Phase II projectwe will expand upon our existing work by developing new technology including on cartridge heaters and dried reagents that would enable our FINDER platform to perform CMV testing in a hospital or clinic setting using single use cartridges and readily obtainable saliva samplesThe FINDER instrument is in the final stages of development for single sample biochemical newborn screeningOnce the technology is developedwe will improve DNA extraction efficiencyfurther reduce time to resultsand perform an analytical validation of the assayWe will then perform a small method comparison study usingretrospective and prospectively collected neonatal saliva samples at each of two sitesUAB and Duke UniversityA near patient newborn screening platform for combined biochemical and molecular testing has the ability to introduce new targeted and universal single sample tests for newborn screening