Inulin immunoassay for kidney function

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$97,905.00
Award Year:
2010
Program:
SBIR
Phase:
Phase I
Contract:
1R43DK088349-01
Award Id:
96050
Agency Tracking Number:
DK088349
Solicitation Year:
n/a
Solicitation Topic Code:
NIDDK
Solicitation Number:
n/a
Small Business Information
BIOPAL, INC, 80 WEBSTER ST, WORCESTER, MA, 01603
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
009796223
Principal Investigator:
ERNEST GROMAN
(508) 770-1190
Business Contact:
GROMAN
() -
Research Institute:
n/a
Abstract
DESCRIPTION (provided by applicant): The absence of a widely accepted commercially available method to measure glomerular filtration rate (GFR) in animal models and in the clinic has had profoundly negative effects on (i) developing methods and drugs for t reating kidney disease, (ii) accurately assessing kidney transplant recipients and donors, (iii) calibrating drug dosing in the young and elderly, (iv) minimizing nephrotoxicity in the drug development process, and (v) accurately assessing nephrotoxicity i n the clinical setting. Inulin is the gold standard for measuring GFR. A sensitive, specific and easy assay to measure inulin is most likely to be accepted for general research, clinical research, and clinical applications. A diagnostic test for inulin usi ng immunoassay techniques to measure its clearance from the kidney offers a unique opportunity for a needed technology and an analytical tool superior to all current methods. We have raised polyclonal antisera to inulin and propose to develop a set of reag ents that demonstrate the feasibility of measuring inulin using immunoassay. An inulin immunoassay avoids the shortcomings of other inulin assays and is easy to perform, cost effective, highly specific, and far more sensitive than currently available inuli n assays. We anticipate that an immunoassay for inulin can be produced wherein all the reagents are stable, the lower limit of detection of inulin is less than 30ng/ml, the specificity of the antibody for inulin allows discrimination between all common sug ars and polysaccharides (both endogenous, synthetic, and botanical), the antibody titer is greater than 10,000, and the assay can be completed within 75 minutes. All of these criteria are necessary for the development of an automated assay for inulin and t he commercialization of this assay. Phase II will demonstrate the application of the reagents to measuring GFR values in animal models. PUBLIC HEALTH RELEVANCE: The project will further develop a diagnostic test to measure kidney function. The test will utilize well-known and widely available analytical technology and will utilize the gold standard for the measure of kidney function. Therefore, this test will be able to quickly enter the market-place.

* information listed above is at the time of submission.

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