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Antigen Immunoassay for Diagnosis of Coccidioidomycosis

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
Program Year/Program:
2012 / SBIR
Agency Tracking Number:
R43AI102377
Solicitation Year:
2012
Solicitation Topic Code:
NIAID
Solicitation Number:
PA11-096
Small Business Information
Immuno-Mycologics INC
2700 Technology Pl. Norman, OK 73071-
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2012
Title: Antigen Immunoassay for Diagnosis of Coccidioidomycosis
Agency: HHS
Contract: 1R43AI102377-01
Award Amount: $586,503.00
 

Abstract:

DESCRIPTION (provided by applicant): Coccidioidomycosis, also known as Valley Fever, is a fungal disease caused by Coccidioides spp. that infects an estimated 150,000 people each year in the United States. Current diagnosis of coccidioidomycosis relieson detection of anti-coccidioidal antibodies in patient sera. However, the sensitivity of this serological assay is particularly low in the first few weeks of illness. A promising strategy to improve early diagnosis of Coccidioides infections is to detect specific protein antigens from Coccidioides which are shed into urine or serum. However, antigenuria/antigenemia-based diagnostic assays for coccidioidomycosis are not yet available, resulting in a critical need for the development of this type of diagnostic. The goal of this project is an immunoassay that will use serum or urine as a sample to diagnose coccidioidomycosis. Our overall hypothesis is that protein biomarker targets are shed into the urine or serum of Coccidioides-infected mice. The approachwill be the use of scFv phage display technology to facilitate the identification of Coccidioides biomarkers in urine and serum from Coccidioides-infected mice. The product will be an immunoassay in the lateral flow assay (LFA) or enzyme immunoassay (EIA)format in order to facilitate earlier diagnosis of coccidioidomycosis. Criteria for success of this Phase I SBIR would be the identification and validation of at least one protein biomarker from the urine or serum of Coccidioides-infected mice. If the goals of this Phase I project are achieved, a Phase II application will use the protei biomarker(s) and/or antibody(s) generated from this Phase I project to construct and evaluate an immunoassay in LFA or EIA format. If successful, this translational researchproject could dramatically decrease the morbidity and health care costs associated with coccidioidomycosis through earlier diagnosis. PUBLIC HEALTH RELEVANCE: Coccidioidomycosis is a common and sometimes life-threatening, fungal infection which is difficult to diagnose early due to its symptomatic similarit to viral and bacterial infections. This is a translational research study whose initial goal is to identify biomarkers that are shed into the urine or serum of Coccidioides-infected mice with the ultimate goal of developing an immunoassay that will facilitate earlier diagnosis of coccidioidomycosis. If successful, this project could dramatically decrease the morbidity and health care costs associated with coccidioidomycosis through earlier diagnosis.

Principal Investigator:

Sean Bauman
405-360-4669
sean-bauman@immy.com

Business Contact:

Sean K. Bauman
405-360-4669
sean-bauman@immy.com
Small Business Information at Submission:

IMMUNO-MYCOLOGICS, INC.
2700 TECHNOLOGY PL NORMAN, OK -

EIN/Tax ID: 173107240
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No