ZYMERON CORPORATION — Department of Health and Human Services SBIR Phase II: NIAID

Description

CytomegalovirusCMVis a very common intrauterine infectionaffecting approximately one in everychildrenThe overall disease burden in the US with congenital CMV was estimated at $billion annuallyCMV is also a cause of serious morbidity and fatal infections in immunocompromised patientsThere is currently no generally accepted therapy and developing a CMV vaccine is high priorityCurrently CMV trials require prospective study subjects to make multiple visits and wait for days for their CMV serostatusA point of carePOCdiagnostic test can significantly simplify the enrollment processallowing for real time determination of eligibility and initiating the enrollment in one visitSuch a POC CMV test also has clinical uses in identifying vaccination target populations in resource limited areas to achieve cost effective vaccinationmonitoring the efficacy of CMV vaccinesand screening at risk pregnant womenZymeron develops a low cost POC test that measures CMV serostatus inminutesThe Phase II project will carry out assay optimizationperformance verificationdevice development and subsystem verificationand performance validation of the fully integrated device with clinical samplesThe POC test will be ready for manufacturing transfer and clinical data package