Microgen LLC — Department of Health and Human Services SBIR Phase I: NIAID

Description

Project Summary Congenital CytomegalovirusCMVinfection is a leading cause of birth defects and developmental disabilities in the U Saffecting thousands of children each yearCurrent methodse gtissue cultureshell vial assaysingle copy gene PCR methodsetcto detect CMV infections are labor intensive and require sophisticated equipmentdedicated laboratory spaceand trained techniciansA rapidon site test for newborn screening that could detect CMV in clinical specimens wouldallow for immediate counseling and additional specimen collection for confirmatory testingandavoid having to create new laboratory infrastructure for widespread biospecimen testingWe propose developing a point of care test for rapid screening of congenital CMV infectionThis technology will also result in a significant cost reduction as compared to hospital and clinical pathology laboratory testsThe goal of this project is to develop an inexpensive$per sampleand rapidandltmin from specimen to resultscreening assay for primary CMV infections Project Narrative The goal of this project is to develop a rapidpoint of carePOCassay for newborn screening that could detect CMV in clinical specimensPOC assays to detect neonatal CMV infection in the U Sare currently not availableIf they were availablethey would significantly lower the barriers to widespread screening and timely prevention interventions