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Rapid Point-of-Care Diagnostics to Detect Serologic Status of Individuals for Select Viral Infections

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 75N93019C00031
Agency Tracking Number: N44AI190031
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
104 TW ALEXANDER DR, STE 505, DURHAM, NC, 27709-0002
DUNS: 080123728
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 Zhiguo Zhou
 (919) 748-3319
 jason.shou@zymeron.com
Business Contact
 Zhiguo Zhou
Phone: (919) 748-3319
Email: jason.shou@zymeron.com
Research Institution
N/A
Abstract
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

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

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