NOVEL ASSAY TO DETECT CHRONIC KIDNEY DISEASE

 描述(申请人提供：据估计，美国有2600万慢性肾脏疾病患者。早期诊断和治疗是扭转这一日益严重的问题的唯一经济有效的手段。美国国立卫生研究院认识到在慢性肾脏病的发病和发展阶段进行早期诊断的挑战，以防止进一步的肾脏损害，降低心血管风险，并将慢性肾脏病的经济影响降至最低。目前，两种免费的检测方法--估计的肾小球滤过率(EGFR)和尿白蛋白/肌酐比值(UACR)--被用来确定慢性肾脏病，并且在疾病发生后有效。我们将生产一种新的用于慢性肾脏病的酶联免疫吸附试验，作为一种诊断试验，基于一种新的反映肾脏疾病病理生理学关键事件的生物标志物的使用。初步结果表明 我们的CKD分析可以取代或补充这两种谓词分析。此外，结果的特异性和重复性可能会减少或消除重复测试的需要。 除了增加便利性和缩短治疗时间外，这可能意味着CKD的筛查成本可能会大大降低。我们的CKD检测将使医生能够评估最近被诊断为高血压、糖尿病或有CKD家族史的患者。在第一阶段，我们评估了这项测试的可行性和原理证明 并发现，在这两个高危人群中，原型检测都具有高度的敏感性和特异性。在第二阶段，我们确认了我们的CKD检测的特异性，建立了与其他检测的一致性，并寻找可能影响检测性能的其他因素。我们请求IIB阶段的支持，以便我们能够准备cGMP试剂盒，执行关键的临床评估，向FDA提交我们的510(K)申请，并为商业推出做准备。

 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.