NOVEL ASSAY TO DETECT CHRONIC KIDNEY DISEASE

DESCRIPTION provided by applicant There are an estimated 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 k application to the FDA and prepare for commercial launch PUBLIC HEALTH RELEVANCE Chronic Kidney Disease affects nearly million people in the United States which places them at higher risk of cardiovascular disease hemodialysis and end stage renal disease We will develop an assay for identification of people with advanced kidney disease that are under diagnosed by current methods and to aid physicians in earlier treatment and better assessment of chronic kidney disease