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 treating 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 in the clinical setting. Inulin is the gold standard fo measuring GFR. A sensitive, specific and easy assay to measure inulin is most likely to be accepted for general research, clinical research, and in the clinic. Inulin is free of any controversy associated with gadolinium chelates often proposed as GFR probes. We have completed all specific aims outlined in our Phase I application yielding a research immunoassay for inulin and a diagnostic test to measure glomerular filtration rate. Our inulin ELISA avoids the shortcomings of other inulin assays, is easy to perform, cost effective, highly specific, and far more sensitive than currently available inulin assays. All reagents are stable, the lower limit of inulin detection is less than 10ng/ml, the specificity of the antibody for inulin allows discrimination between inulin and all common sugars and polysaccharides. Completion of Phase II will see the launch of two products and one service. The two products are inulin in sodium chloride injection, USP, and a cGMP FIT-GFR inulin kit. The service provides a CLIA licensed laboratory equipped to measure and report GFR (mGFR) determinations from samples obtained from research laboratories, veterinary and medical practices.
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 ale to quickly enter the market-place.