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.

项目概要 NIH SBIR 第二阶段，2017 年 1 月 5 日 申请标题：“用于在护理点监测心力衰竭的一次性检测” 加速诊断有限责任公司 联系 PI：Alberto Gandini，博士，MBA 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)。拟议的 活动包括集成智能手机应用程序、扩大遵循 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（一次性使用），不需要台式或手持设备， 因此它易于使用且价格非常实惠；它也是一种定量且灵敏的测定方法，因此 提供心力衰竭中脑钠肽 (BNP) 水平的准确且精确的定量 患者的血液。 BNP 是一种心脏生物标志物，由心脏组织在受到压力时产生 心力衰竭发作。它以其诊断心力衰竭的特异性和敏感性而广为人知。 心力衰竭仍然是美国老年人死亡和残疾的主要原因，并将 每年花费超过 400 亿美元，给医疗保健系统带来沉重负担。早期诊断是 实现有意义的结果改变的关键必要性。 pScreen-BNP™ 在这方面标志着， 心力衰竭管理的范式转变。它第一次允许心力衰竭患者经常监测他们的情况 临床环境之外的心脏病程度，例如在舒适的家中，类似于 比较熟悉的血糖测试。我们的解决方案将使患者及其医生能够做出反应 在身体症状出现之前，防止频繁发生危及生命的事件和昂贵的重新治疗 住院治疗。 pScreen-BNP™ 基于最初由 卡内基梅隆大学，并在全球范围内独家授权 Accel Diagnostics。