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Development of a point of care lateral flow diagnostic to test for acute and past hepatitis E (HEV) in saliva

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R43AI141265-01
Agency Tracking Number: R43AI141265
Amount: $225,000.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PA17-302
Timeline
Solicitation Year: 2017
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-07-01
Award End Date (Contract End Date): 2019-06-30
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
 STEVEN OLDENBURG
Phone: (619) 890-0704
Email: steven.oldenburg@nanocomposix.com
Research Institution
N/A
Abstract
The goal of this Phase I research project is to develop a point of care lateral flow assay to determine the presence of a serological response to hepatitis E virus in a saliva sampleHepatitis EHEVis a viral hepatitis that has high mortality rates in immunocompromised and pregnant individualsHEV can develop into an acutesevere liver disease that is fatal in aboutof all casesApproximatelymillion people were newly infected with HEV inThere is currently no FDA approved point of care diagnostic for HEV which has limited the ability of researchers and health care professionals to track and diagnosis the diseaseThe proposed diagnostic test is based on a lateral flow test strip format that is inexpensiverapidcan be read by eyeand has a multi year shelf life without refrigerationSaliva sampling is minimally invasive and greatly facilitates study participation and continuous monitoring of at risk areasThis is a collaborative proposal between nanoComposixhepatitis E experts from the Johns Hopkins Bloomberg School of Public HealthJHBSPand Salimetricsa world leader in salivary diagnosticsOur team is ideally suited to transition a salivary HEV test developed by JHSBP on a Luminex platform into a point of care lateral flow assayLFAfor research and clinical useThe development of a salivary HEV LFA will enable population based research studies to better understand the epidemiology and disease ecology of HEV and provide an effective and inexpensive test for surveillance and rapid diagnosis to mitigate future HEV epidemics Project narrative There are a number of different viruses that result in a hepatitis infection that can cause serious liver inflammation and damageHepatitis EHEVis a harmful variant that does not have an FDA approved diagnostic for point of care useIn this project we will develop a lateral flow salivary diagnostic test for HEV that will allow researchers and health care workers to rapidly and non invasively collect HEV infection data and monitor populations for outbreaks

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

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