Low cost quantitative monitoring of kidney injury biomarkers using a glucometer

描述(申请人提供)：虽然美国每个人都能感受到高昂的医疗费用，但对肾衰竭患者的经济影响尤其显著，因为透析治疗每年可达85,000美元，而移植是唯一已知的治疗方法。因此，今天的肾脏移植占美国所有移植手术的一半以上，每年大约有17,000例移植手术。不幸的是，在这些移植患者中，观察到高达29%的肾衰竭发生率，23%的肾移植受者也发生移植功能延迟。为了解决这个问题，已经开发了强大的免疫抑制疗法来减少移植并发症的机会，但这种疗法可能并不是对所有患者都是必要的或合适的。因此，移植物衰竭的早期预警通过允许更早、更少的强度和更有效的治疗干预，具有显著的积极的经济和健康影响。目前评估肾功能的标准做法是通过侵入性肾活检。不幸的是，从患者肾脏中取出微小的、随机的组织样本的过程会导致显著的抽样误差；此外，活检的组织学评估是主观的 在不同的病理学家之间，甚至在同一病理学家审查同一肾脏的相反两极的活检组织时，可能会有所不同。生物标志物如肌酐、肾小球滤过率和蛋白尿也被用于评估肾功能；然而，它们的预测能力有限。在肾脏损伤的几个潜在生物标志物中，肾脏损伤分子-1(Kim-1)在临床环境和动物模型中得到了很好的研究。Kim-1被排入尿液 作为一种可溶形式，它在24小时内稳定，因此它在尿液中的检测是非侵入性的。在某些情况下，对于同种异体移植物的损伤，Kim-1比组织学更敏感。临床实验室测试可用于量化尿液中的Kim-1，以及试纸测试，以定性检测Kim-1的存在。然而，这两项检测都不能以合理的成本对Kim-1水平进行常规量化；能够定量监测Kim-1水平可以确定肾脏损伤的严重程度、临床环境中患者的风险分层，以指导治疗并确定肾脏损伤是改善还是恶化。为了实现这一目标，GLucoSentient正在开发一种有效、负担得起、易于使用的Kim-1定量监测设备。我们可以通过开发肾损伤生物标志物的分析来实现这一目标，以Kim-1为初始目标，与现有的血糖仪一起使用，这些血糖仪基于低成本、易于构建的电化学传感器。通过将基于黄金标准抗体的检测与低成本检测技术相结合，GLucoSentient将开发一种最终产品，使肾移植后的患者能够通过经常检测尿液中的Kim-1来监测他们的肾功能。我们相信，这种产品可以极大地提高移植后患者的生活质量，并降低相关成本 肾功能衰竭和功能障碍。

DESCRIPTION (provided by applicant): While the high costs of healthcare in the U.S. can be felt by everyone in the country, the economic impact to patients with kidney failure is particularl significant as dialysis treatments can reach $85,000 annually, with transplantation being the only known cure. Therefore, kidney transplants today make up more than half of all transplants performed in the U.S., with roughly 17,000 transplants every year. Unfortunately, up to 29% of kidney failure rate is observed for a subset of these transplant patients and delayed graft function also occur in 23% of these kidney recipients. To address this issue, powerful immunosuppressant therapies have been developed to reduce the chances of transplant complications, but such therapies may not be necessary or appropriate for all patients. Therefore, early warning of graft failure has a significant positive economic and health impact by allowing earlier, less intensive, and more effective therapeutic intervention. The current standard practice for evaluating kidney function is through an invasive renal biopsy. Unfortunately, the process of removing a tiny, random tissue sample from patient's kidney leads to significant sampling errors; moreover, the histological evaluation of the biopsies is subjective and can vary amongst pathologists or even the same pathologist reviewing biopsies from opposite poles of the same kidney. Biomarkers such as creatinine, glomerular filtration rate, and proteinuria have also been used for evaluating kidney function; however, they are limited in their prediction power. Among several potential biomarkers for kidney injury, Kidney Injury Molecule-1 (Kim-1) is well studied in the clinical setting and in the animal model. Kim-1 is shed into urine as a soluble form and it is stable for up to 24 hours, therefore its detection in urine is not invasive. In some instance, Kim-1 is more sensitive than histology for allograft injury. Clinical laboratory tests are available for quantifying Kim-1 in the urine as well as a dipstick test that cn qualitatively detect the presence of Kim-1. Neither test, however, allows for routine quantification of Kim-1 levels at a reasonable cost; being able to monitor the Kim-1 level quantitatively allows the potential for identifying the severity of kidney injury, risk stratificaton of patients in clinical setting, to guide therapy and determine if kidney injury is improving or gettig worse. Towards this goal, GlucoSentient is developing a quantitative monitoring device for Kim-1 that is effective, affordable, and easy to use. We can achieve this goal by developing assays for biomarkers for kidney injury, with Kim-1 as the initial target, to be used with existing glucometers, which are based on low-cost, easy to construct electrochemical sensors. By combining the gold standard antibody based assay with low cost detection technology, GlucoSentient will develop a final product that allows post-kidney-transplant patients to monitor their kidney function by frequently measuring Kim-1 in urine. We believe this product can greatly increase the quality of life for post-transplant patient as well as reduce the associated costs for kidney failure and dysfunction.