A disposable assay for the monitoring of heart failure in the home setting.

项目摘要 NIH SBIR第二阶段，2017年1月5日 申请标题：“用于在床旁监测心力衰竭的一次性测定” Accel Diagnostics，LLC 联系PI：Alberto Gandini，Ph.D.，MBA 这一拟议的SBIR第二阶段的目标是完成 pScreen-BNP™平台，用于监测家庭患者的心力衰竭（HF）。拟议 活动包括集成智能手机应用程序，扩大制造能力， FDA质量控制指南，降低生产成本，并完成临床验证研究， 与加州旧金山弗朗西斯科合作。pScreen-BNP具有几个独特的 功能.它是完全一次性的（单次使用），不需要台式或手持设备， 因此，它易于使用且价格低廉;它还是一种定量且灵敏的测定法，因此，它 提供了HF患者脑钠肽（BNP）水平的准确和精确定量 病人的血。BNP是一种心脏生物标志物，当心脏组织受到压力时， 心力衰竭发作。众所周知，它在HF诊断中具有特异性和敏感性。 心力衰竭仍然是美国老年人死亡和残疾的主要原因， 医疗保健系统的重大负担，每年的成本超过400亿美元。早期诊断是 这是实现有意义的成果改变的关键。pScreen-BNP™在这方面具有标志性， HF管理的范式转变。它首次允许HF患者频繁监测他们的 在临床环境之外的心脏不适水平，例如在舒适的家中，类似于 更熟悉的葡萄糖测试。我们的解决方案将使患者和他们的医生能够响应 在身体症状发生之前，防止频繁的危及生命的事件和昂贵的重新治疗， 住院治疗pScreen-BNP™基于一项受专利保护的技术，最初开发于 卡内基梅隆大学，并授权全球独家Accel诊断。

Project Summary NIH SBIR Phase-II, Jan 5, 2017 Application Title: “A disposable assay for the monitoring of heart failure at the point-of-care” Accel Diagnostics, LLC Contact PI: Alberto Gandini, Ph.D., MBA The objective of this proposed SBIR Phase II is to complete the development and optimization of the pScreen-BNP™ platform for the monitoring of Heart Failure, HF, in home patients. The proposed activities include integration of a smart phone app, scale up manufacturing capability that adhere to the FDA Quality Control guidelines, reduce production cost, and complete a clinical validation study in collaboration with The University of California San Francisco. The pScreen-BNP has several unique features. It is fully disposable (single use) and does not requires bench-top or hand-held devices, hence it is easy to use and very affordable; it is also a quantitative and sensitive assay, hence it provides an accurate and precise quantification of the level of Brain Natriuretic Peptide (BNP) in HF patients' blood. BNP is a cardiac biomarker elaborated by heart tissue when stressed due to the onset of heart failure. It is widely known for its specificity and sensitivity in the diagnosis of HF. Heart Failure remains a leading cause of death and disability in elderly Americans, and places a significant burden on the healthcare systems with a cost exceeding $40 billion/year. Early diagnosis is a critical necessity to achieve meaningful change in outcome. pScreen-BNP™ marks in this respect, a paradigm shift in HF management. It allows, for the first time, HF patients to frequently monitor their level of heart distress outside of the clinical setting, e.g. in the comfort of their homes, similar to the more familiar glucose test. Our solution would enables patients and their physicians to respond before physical symptoms occur, preventing otherwise frequent life threatening events and costly re- hospitalizations. pScreen-BNP™ is based on a patent-protected technology initially developed at Carnegie Mellon University, and licensed exclusively Worldwide to Accel Diagnostics.