FAST-CMV: A Point-of-Care Cytomegalovirus Serodiagnostic and Avidity Assy

Congenital cytomegalovirusCMVinfection is the leading cause of permanent disabilitiescognitive impairmentand sensorineural hearing loss to newbornsMaternal infections that occur during pregnancy and symptomatic congenital CMV infections have been correlated with the most severe complicationsClinical trials are currently evaluating safety and immunogenicity of diverse vaccine candidates driven by the moderate efficacy of a glycoprotein B vaccine in recent studiesDue to the seroprevalence of CMVclinical trial enrollment is financially and logistically challenging and there is a need for a rapid diagnostic to determine serostatus at the point of careTo meet this need Luna will develop the FASTCMV technologyThe platform will feature disposable microfluidic cartridgeshighly sensitive automated electrochemical ELISAsand a benchtop analyzer to detect CMV antibodies and lgG avidityDuring Phase ILuna developed ELISA reagents for lgM and lgG detectiondeveloped and characterized electrochemical detection methodsand demonstrated feasibility of the proposed approachLuna also designed microfluidic cartridges and instrumentation with clinical and manufacturing partnersRapid prototypingmanufactureand validation will occur during Phase II prior to seeking FDA clearance and CLIA waiver in Phase IllLuna has assembled an interdisciplinary team of scientificclinicaland manufacturing experts to rapidly commercialize FAST CMV