Diagnostic Assays for Rheumatic Diseases

Award Information
Agency:
Department of Health and Human Services
Branch:
N/A
Amount:
$99,999.00
Award Year:
2001
Program:
STTR
Phase:
Phase I
Contract:
PHS2001-2
Agency Tracking Number:
1R41AI050350-01
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
JK AUTOIMMUNITY, INC.
800 RESEARCH PKW, STE 100, OKLAHOMA CITY, OK 73104, OKLAHOMA CITY, OK, 73104
Hubzone Owned:
N
Socially and Economically Disadvantaged:
N
Woman Owned:
N
Duns:
N/A
Principal Investigator
 JOHN HARLEY
 (405) 271-7768
 JOHN-HARLEY@OMRF.OUHSC.EDU
Business Contact
 KAUFMAN, KENNETH
Phone: (405) 271-7406
Email: KAUFMANK@OMRF.OUHSC.EDU
Research Institution
 OKLAHOMA MEDICAL RESEARCH FOUNDATION
 OKLAHOMA MEDICAL RESEARCH FOUNDATION
OKLAHOMA CITY, OK, 73152
 Nonprofit college or university
Abstract
DESCRIPTION (provided by applicant): The diagnosis of systemic lupus erythematosus is a serious public health problem. Almost 90 percent of the 2,000,000 people who have been told that they have lupus do not fulfill the diagnostic criteria to classify a person as having lupus. The laboratory test used to screen for lupus is largely to blame. This antinuclear antibody test and its derivatives are very sensitive (>95 percent), but are not specific (<2 percent). Other serological tests for lupus are specific, but not sensitive (i.e., anti-native DNA and anti-Sm autoantibodies). Through fine specificity immunochemical work, peptides have been found that tend to be bound by normal sera and others that are bound by lupus sera. Our first goal is to develop these assays for commercial application. Less expensive antigen-antibody binding reagents and conditions suitable for commercial performance are sought. Four substrate chemistries will be explored. Other goals include developing peptide-based assays to replace existing assays for anti-Sm, anti-nRNP, and anti-Ro. Some preliminary data suggest that patients with lupus nephritis who do not respond to aggressive immunosuppressive therapy can be identified through a peptide-based solid phase assay. The development of this assay will also be explored. The successful completion of this project will lead to improved clinical care of patients with suspected systemic lupus erythematosus by helping make products available to the marketplace that will more precisely diagnose this disease and assist its management. PROPOSED COMMERCIAL APPLICATION: The products will be used to help diagnose systemic lupus erythematosus, to identify particular antibody systems with prognostic value, and to identify patients who are not likely to respond to immunosuppressive therapy.

* information listed above is at the time of submission.

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