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

用于在家庭环境中监测心力衰竭的一次性测定。

• 批准号: 9408688
• 负责人: Alberto Gandini
• 金额: $ 61.2万
• 依托单位: ACCEL DIAGNOSTICS, LLC
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-04-01 至 2019-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9408688
• 关键词: Address; Admission activity; Affect; American; Android; Area; Biological Assay; Biological Markers; Blood; Blood Tests; Blood specimen; Brain natriuretic peptide; Buffers; Bulla; California; Cardiac; Cause of Death; Cellular Phone; Clinical; Clinical Trials; Collaborations; Communication; Computer software; Cost Control; Data; Data Set; Development; Devices; Diagnosis; Diagnostic; Distress; Doctor of Philosophy; Early Diagnosis; Elderly; Engineering; Evaluation; Event; Feasibility Studies; Financial Support; Fingers; Freezing; Funding; Glucose; Growth; Guidelines; Hand; Health; Health Insurance Portability and Accountability Act; Healthcare Systems; Heart; Heart failure; Home environment; Hospitalization; Human; Immunoassay; Industry; Information Systems; Intuition; Legal patent; Life; Measurement; Medical History; Medical Technology; Medicare; Monitor; Outcome; Patients; Performance; Phase; Physicians; Physicians' Offices; Population; Privatization; Procedures; Production; Protocols documentation; Quality Control; Quality of life; Reader; Route; Sample Size; Sampling; San Francisco; Scientist; Sensitivity and Specificity; Severities; Small Business Innovation Research Grant; Stress; Symptoms; System; Technology; Testing; Time; Tissues; United States National Institutes of Health; Universities; Validation; Veterans; base; cloud based; cohort; compliance behavior; cost; data management; design; digital; disability; improved; innovation; mHealth; manufacturing scale-up; meetings; mobile application; mobile computing; patient population; physical symptom; point of care; pre-clinical; preclinical evaluation; prevent; primary care setting; prototype; scale up; success; usability; validation studies; waiver

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.

项目摘要 NIH SBIR II期，2017年1月5日 申请标题：“用于监测心力衰竭的一次性测定” Accel Diagnostics，LLC 联系PI：Alberto Gandini博士，MBA 该提出的SBIR II期的目的是完成和优化 PSCREEN-BNP™平台，用于监测家庭患者心力衰竭的HF。提议 活动包括集成智能手机应用程序，扩展遵守的制造能力 FDA质量控制指南，降低生产成本并完成一项临床验证研究 与加州大学旧金山分校合作。 Pscreen-BNP有几个独特的 特征。它是完全一次性的（一次性），不需要台面或手持设备， 因此，它易于使用并且非常实惠；它也是一种定量和敏感的评估，因此 在HF中提供精确而精确的脑纳替肽（BNP）的水平 患者的血液。 BNP是一种心脏组织的心脏生物标志物，因为 心力衰竭的发作。它以其在HF诊断中的特异性和敏感性而闻名。 心力衰竭仍然是美国人的死亡和残疾的主要原因，并将 耗资超过400亿美元/年的医疗保健系统上的大量燃烧。早期诊断是 实现有意义变化的必要必要的结果。在这方面，Pscreen-BNP™标记， HF管理的范式转变。它首次允许HF患者经常监视他们的 临床环境之外的心脏痛苦水平，例如在他们的家中，类似于 更熟悉的葡萄糖测试。我们的解决方案将使患者及其医生能够做出回应 在身体症状发生之前，防止其他经常危及生命的事件，并昂贵的重新 住院。 Pscreen-BNP™基于最初开发的专利保护技术 卡内基·梅隆大学（Carnegie Mellon University），并在全球范围内获得授权诊断。