NOVEL ASSAY TO DETECT CHRONIC KIDNEY DISEASE

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 DESCRIPTION (provided by applicant: There are an estimated 26 million Americans with chronic kidney disease (CKD). Early diagnosis and treatment are the only cost-effective means to reverse this growing problem. NIH recognizes the challenge to diagnose CKD early during its initiation and development phases in order to prevent further renal damage, reduce cardiovascular risk, and minimize the economic impact of CKD. Currently, two complimentary tests - estimated GFR (eGFR) and urine albumin-to-creatinine ratio (UACR) - are used to identify CKD and are effective once the onset of disease has occurred. We will produce a new ELISA for CKD to be employed as a diagnostic test based upon the use of a novel biomarker that reflects critical events in the pathophysiology of kidney disease. Preliminary results suggest that our CKD-ASSAY could replace or compliment both predicate assays. Further, the specificity and reproducibility of the results may reduce or eliminate the need for repeat testing. Aside from increased convenience and reduced time to treatment, this may mean that the cost of screening for CKD may be greatly reduced. Our CKD-ASSAY would give physicians the ability to evaluate patients that have been recently diagnosed with hypertension, diabetes, or a family history of CKD. In Phase I, we evaluated the feasibility and proof-of principal of this test and found that the prototype assay in both at-risk populations was highly sensitive and specific. In Phase II, we confirmed the specificity of our CKD-ASSAY, established concordance with other assays, and looked for other factors that might have impacted on assay performance. We request Phase IIB support so that we can prepare cGMP kits, perform the pivotal clinical evaluations, submit our 510(k) application to the FDA, and prepare for commercial launch.