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

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 75N93019C00032
Agency Tracking Number: N44AI190032
Amount: $1,499,994.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: N/A
Timeline
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
301 1ST STREET SW, SUITE 200
ROANOKE, VA 24011-1921
United States
DUNS: 627132913
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 Nathaniel Talley
 (434) 972-9951
 talleyn@lunainc.com
Business Contact
 Nathaniel Talley
Phone: (434) 972-9951
Email: talleyn@lunainc.com
Research Institution
N/A
Abstract

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

* Information listed above is at the time of submission. *

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