Immunoassay for diagnosis of invasive fungal disease

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R41AI102311-01A1
Agency Tracking Number: R41AI102311
Amount: $600,000.00
Phase: Phase I
Program: STTR
Awards Year: 2013
Solitcitation Year: 2013
Solitcitation Topic Code: NIAID
Solitcitation Number: PA12-089
Small Business Information
Duns: 99550915
Hubzone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (405) 360-4669
Business Contact
Phone: (405) 360-4669
Research Institution
 Office of Sponsored Projects
204 Ross Hall Mailstop 325
RENO, NV, 89557-
 () -
 Nonprofit college or university
DESCRIPTION (provided by applicant): Early diagnosis of infectious disease is critical to patient outcome. An important early question is - is it a fungus, a bacterium or a virus? A rapid answer to this question would allow preemptive treatment that cansave lives. The goal of this project is a rapid and inexpensive immunoassay that will use serum as a sample to broadly identify the presence of invasive fungal disease (IFD). This is an unmet need for diagnosis of fungal infection, particularly for testsnear the point of patient care. The target population willbe individuals for whom advanced medical intervention and use of potent immunosuppressive drugs has led to a proliferation of opportunistic and endemic fungal infection. The overall hypothesis is that selected polysaccharide and protein antigens are produced by pathogenic fungi that are shared across the genera that produce invasive disease. Moreover, a subset of these antigens is shed into blood in concentrations that would allow for detection. Theapproach will be immunoassay for the presence of two distinct antigens that i) are shared across fungal species that cause IFD and ii) are shed into blood during infection. Simultaneous detection of two distinct antigens will markedly enhance the predictive value. The product will be assays with the lateral flow immunoassay (LFA) and/or enzyme-linked immunoassay (ELISA) platforms. Criteria for success in this Phase I STTR would be production of mAbs reactive with two distinct fungal antigens, one a polysaccharide and the other a protein, that are shared by the major causes of IFD. Targeting of two independent antigens will produce an assay with a high predictive value. If this Phase I project is successful, a Phase II application would construct immunoassaysin LFA or ELISA format and perform pre- clinical validation for broad diagnosis of invasive fungal disease. If successful, this translational research project could reduce mortality due to invasive fungal disease through earlier diagnosis and treatment.PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: Invasive fungal disease (IFD) is one of the most devastating complications of advanced medical care and use of powerful immunosuppressive drugs. IFD is difficult to diagnose and difficult to treat.This is a translational research study whose goal is n immunoassay for early, rapid, inexpensive and non-invasive diagnosis of IFD. If successful, the project could dramatically reduce morbidity and mortality from IFD through early diagnosis and treatment.

* information listed above is at the time of submission.

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