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Urine Diagnostics for Aspergillosis

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41AI115866-01
Agency Tracking Number: R41AI115866
Amount: $238,175.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIAID
Solicitation Number: PA14-072
Solicitation Year: 2015
Award Year: 2015
Award Start Date (Proposal Award Date): 2015-02-01
Award End Date (Contract End Date): 2016-05-31
Small Business Information
Halethorpe, MD 21227-3831
United States
DUNS: 079332340
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: No
Principal Investigator
 (410) 614-9141
Business Contact
Phone: (703) 851-6757
Research Institution
BALTIMORE, MD 21287-0005
United States

 Domestic Nonprofit Research Organization

DESCRIPTION provided by applicant Aspergillosis is a severe fungal infection that most frequently involves the lungs in people who have immune deficiency caused by cancer chemotherapy and or transplantation Although good drugs are available establishing a diagnosis is difficult and late treatment has limited our progress in decreasing morbidity and mortality We observed that Aspergillus polysaccharide antigens are excreted in urine in animal models and humans with disease Using a novel monoclonal Ab that detects galactofuranose containing Aspergillus antigens in urine we have developed a diagnostic test that relies on lateral flow technology enabling use at near point of care Results of proof of concept studies suggest that this device detects antigens early during the course of disease This phase I application is developed to address two aims To determine the performance characteristics of this prototype assay when used as an aid to diagnose suspected infection and To determine the performance characteristics of this assay when used to screen high risk patients for early disease Successful validation of the assay will enable phase II development for use of this novel assay in screening and early treatment strategies

PUBLIC HEALTH RELEVANCE About people in the U S are at risk for a lung infection called invasive aspergillosis which kills of people who get it The urine test we
want to develop in this application uses a new method which makes finding out who has the infection fast and easy We propose to study the urine test in people who have had invasive pulmonary aspergillosis and develop it as a screening tool for this infection in high risk patients

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

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