NOVEL ASSAY TO DETECT CHRONIC KIDNEY DISEASE

 描述（由申请人提供）：估计有2600万美国人患有慢性肾病（CKD）。早期诊断和治疗是扭转这一日益严重的问题的唯一具有成本效益的手段。NIH认识到在CKD的起始和发展阶段早期诊断CKD的挑战，以防止进一步的肾损伤，降低心血管风险，并最大限度地减少CKD的经济影响。目前，两个免费的测试-估计GFR（eGFR）和尿白蛋白与肌酐比值（UACR）-用于识别CKD，一旦疾病发生，就有效。我们将生产一种新的CKD ELISA，作为一种诊断测试，基于使用一种新的生物标志物，反映肾脏疾病的病理生理学中的关键事件。初步结果表明 我们的CKD-ASSAY可以替代或补充两种实质等同检测。此外，结果的特异性和再现性可以减少或消除重复测试的需要。 除了增加便利性和减少治疗时间外，这可能意味着筛查CKD的成本可能会大大降低。 我们的CKD-ASSAY将使医生能够评估最近被诊断患有高血压，糖尿病或CKD家族史的患者。在第一阶段，我们评估了该测试的可行性和原理证明 并发现在这两个高危人群中的原型检测是高度敏感和特异的。在II期研究中，我们证实了CKD-测定的特异性，建立了与其他测定的一致性，并寻找可能影响测定性能的其他因素。我们请求IIB期支持，以便我们能够准备cGMP试剂盒，进行关键临床评价，向FDA提交510（k）申请，并为商业上市做准备。

 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.