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Rapid diagnostic to determine CMV serological status

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 75N93019C00030
Agency Tracking Number: N44AI190030
Amount: $1,500,000.00
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
4878 Ronson CT STE K, SAN DIEGO, CA, 92111-1806
DUNS: 159070825
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 Richard Baldwin
 (858) 349-5094
 baldwin@nanocomposix.com
Business Contact
 Richard Baldwin
Phone: (858) 349-5094
Email: baldwin@nanocomposix.com
Research Institution
N/A
Abstract
The goal of this project is to develop a diagnostic that can support the enrollment of seronegative individuals in clinical trials of candidate cytomegalovirusCMVvaccinesCongenital CMV infection is one of the leading causes of non genetic birth defects worldwideIf a successful vaccine can be brought to marketit will have a significant impact on the number of babies born with hearing and vision lossintellectual impairmentsmall head size and other neurological disordersA lateral flow rapid test diagnostic was developed that detects both IgG and IgM response to the presence of the virusThe test uses gold nanoshells as the reporter particles to achieve the required high level of sensitivityIn an initial study withclinical samples using the Phase I prototypeasensitivity andspecificity was obtainedThe lateral flow test format is inexpensivesimple to operaterequires only fingerstick blood samplingand has multi year stability without refrigerationA visual signal is obtained in less thanminutes allowing for same visit diagnosis and enrollment of candidate CMV vaccine trial subjects

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

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