DEVELOPMENT OF AN IMMUNOSPECIFIC ASSAY FOR HGB A1C

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$293,000.00
Award Year:
1987
Program:
SBIR
Phase:
Phase II
Contract:
n/a
Agency Tracking Number:
2954
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
Leeco Diagnostics, Inc.
21705 Evergreen Road, Southfield, MI, 48075
Hubzone Owned:
N
Socially and Economically Disadvantaged:
N
Woman Owned:
N
Duns:
n/a
Principal Investigator:
Jin Po Jameslee
Principal Investigator
(313) 353-2620
Business Contact:
() -
Research Institution:
n/a
Abstract
THE PRIMARY OBJECTIVE OF THIS EFFORT IS TO IMPROVE EXISTING METHODOLOGIES FOR ASSAY OF HEMOGLOBIN A1C IN HUMAN BLOOD BY UTILIZING MONOCLONAL ANTIBODY TECHNOLOGY IN THE DEVELOPMENT OF AN IMMUNOSPECIFIC ASSAY. THE CLINICAL USEFULNESS OF THE ASSAY AS AN OBJECTIVE MEASURE OF LONG-TERM CARBOHYDRATE CONTROL OF DIABETIC PATIENTS, IN MONITORING AND ENCOURAGEMENT OF PATIENT COMPLIANCE, IN REVERSAL OF CERTAIN PATHOLOGICAL SEQUELAE OF DIABETES, IN LOWERED PERINATAL MORTALITY AND MORBIDITY TO PREGNANT DIABETICS, IN MINIMIZATION OF HYPOGLYCEMIC REACTIONS, AND AS AN ADJUNCTIVE TEST OF HIGH SPECIFICITY IN THE DIAGNOSIS OF DIABETES MELLITUS, HAS BEEN FAVORABLY DISCUSSED IN RECENT LITERATURE. THE PHASE I EFFORT CONSISTS OF THE PREPARATION OF HIGHLY PURIFIED HEMOGLOBIN A1C AS AN IMMUNOGEN AND THE PRODUCTION AND INITIAL CHARACTERIZATION OF MONOCLONAL ANTIBODIES FROM HYPERIMMUNIZED MICE. COMPLETE CHARACTERIZATION OF THE MONOCLONAL ANTIBODIES AND INCORPORATION OF THEM INTO ONE OF TWO ALTERNATIVE APPROACHES TO DEVELOP A HIGHLY SENSITIVE, HIGHLY SPECIFIC IMMUNOASSAY FOR HEMOGLOBIN A1C IS PLANNED UNDER PHASE II. THE UNIQUENESS OF THE PRODUCT DERIVES FROM THE ANTICIPATED IMPROVEMENT IN SENSITIVITY AND SPECIFICITY OVER EXISTING METHODOLOGIES, AND THE HIGH LIKELIHOOD OF COMMERCIAL SUCCESS IS ASSURED BY A LARGE EXISTING MARKET

* information listed above is at the time of submission.

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