SBIR Phase II: A Novel Device for Convenient Therapeutic Drug Monitoring of Tacrolimus

这个小企业创新研究（SBIR）二期项目旨在开发和验证他克莫司（一种广泛用于器官移植患者的免疫抑制药物）的即时监测。正在开发的产品将现有的、发达的、低成本的血糖仪技术与金标准免疫测定平台相结合，从而产生一种可能改善移植患者治疗结果的产品。目前，他克莫司水平监测主要采用实验室检测方法，检测周期长，频繁监测难度大。然而，他克莫司是一种毒性水平仅比治疗水平高几倍的药物，目前不频繁的监测方法在确保患者最有效的药物水平方面效果较差。第二阶段项目将首先优化第一阶段开发的基于他克莫司的血糖仪，随后开发和验证一种一次性设备，该设备将容纳该检测和具有更高灵敏度的血糖监测仪。我们预计该系统由一次性阅读器和读卡器组成，将在二期项目结束时进行开发和验证，为临床验证技术做准备。该项目更广泛的影响/商业潜力在于该技术的未来发展，该技术将扩大他克莫司以外的潜在测试目标。目前市场上的许多药物的治疗范围很窄，还有许多有效的药物由于缺乏密切的监测方法来减少其毒性作用而无法上市。我们正在开发的创新治疗药物监测设备将使许多这些药物变得更容易获得。对于我们目前的目标市场，全世界有成千上万的移植患者在他们的余生中使用他克莫司，我们产品的商业潜力是巨大的。社会影响是相当大的，仅就肾脏移植而言，29%的同种异体移植将在未来五年内失败，原因是免疫抑制药物管理不当，导致失败后的治疗和透析花费数亿美元。为患者提供一个方便的工具来管理他们的药物，可以显著减少肾脏衰竭的数量，从而改善患者的生活，为社会节省大量资金。

This Small Business Innovation Research (SBIR) Phase II project is aiming to develop and validate a point-of-care monitoring for tacrolimus, an immunosuppressive medication widely used by organ transplant patients. The product being developed combines the existing, well-developed and low cost glucose meter technology with the gold standard immunoassay platform, leading to a product that can potentially improve the treatment outcome of transplant patients. Currently, monitoring of tacrolimus level is achieved by using laboratory assays, which has a long turn-around time and frequent monitoring is more difficult. However, tacrolimus is a drug whose toxic level is only couple times higher than its therapeutic level, and current infrequent monitoring approach is less effective to ensure the most effective drug levels in patients. The Phase II project will be achieved by first optimizing the glucose meter based tacrolimus assay developed in Phase I, following by the development and validation a disposable device which will house the assay and a glucose monitor which has an improved sensitivity. We anticipated the system composed of a disposable and a reader will be developed and validated at the end of the Phase II project, preparing the technology for clinical validation.The broader impact/commercial potential of this project lies in the future development of the technology that will expand the potential test targets beyond tacrolimus. Numerous drugs currently on the market have a narrow therapeutic range, as well as many effective drugs that cannot be marketed due to lack of close monitoring methods to reduce their toxic effects. The innovative therapeutic drug monitoring device we are developing will allow many of these drugs become more available. For our current target market, with hundreds of thousands of transplant patients using tacrolimus worldwide for the remainder of their lives, the commercial potential for our product is immense. The social impact is considerable, and for just kidney transplants, 29% of the allografts will fail in the next five years due to improperly managed immunosuppressant medications costing hundreds of millions of dollars for post failure treatment and dialysis. Providing patients with a convenient tool to manage their medication can significantly reduce the number of failed kidneys, leading to better life to the patient and huge savings for the society.