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

一种用于家庭环境中监测心力衰竭的一次性检测方法

• 批准号: 8905933
• 负责人: Alberto Gandini
• 金额: $ 22.51万
• 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 2016-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8905933
• 关键词: Address; Admission activity; American; Anticoagulation; Biological Assay; Biological Markers; Blood; Blood Tests; Blood specimen; Brain natriuretic peptide; Breathing; Businesses; California; Capital; Cardiac; Cardiology; Cause of Death; Chronic; Clinical; Clinical Research; Clinical Trials; Devices; Diagnosis; Diagnostic; Disease; Distress; Early Diagnosis; Elderly; Electronics; Elements; Epidemic; Event; Fatigue; Fingers; Fostering; Freezing; Future; Glucose; Guidelines; Hand; Head; Health; Healthcare Systems; Heart; Heart failure; Home environment; Hospitalization; Human; In Vitro; Institutional Review Boards; Laboratories; Lead; Left Ventricular Dysfunction; Legal patent; Life; Liquid substance; Logistics; Maintenance; Marketing; Measures; Medical Technology; Medical center; Medicare; Monitor; Multi-Institutional Clinical Trial; Nature; Outcome; Outpatients; Pathologist; Patients; Performance; Phase; Physicians; Physicians' Offices; Population; Preparation; Primary Health Care; Production; Reader; Recording of previous events; Sampling; San Francisco; Sensitivity and Specificity; Severities; Small Business Innovation Research Grant; Solutions; Stress; Symptoms; Technology; Testing; Time; Tissues; Translating; Universities; Validation; acute coronary syndrome; base; clinically relevant; commercialization; cost; design; diagnostic assay; disability; follow-up; improved; instrument; multidisciplinary; novel; point of care; point-of-care diagnostics; pre-clinical; prevent; prognostic tool; programs; prototype; public health relevance; research and development; scale up; standard of care; success; telehealth; usability; validation studies

 DESCRIPTION (provided by applicant): The objective of this proposed SBIR Phase 1 is to complete the clinical validation of a novel blood assay, pScreen-BNP(tm), for the monitoring and management of heart failure (HF) in the home and Point-of-Care (POC) settings. pScreen-BNP(tm) 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(tm) 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 enables patients and their physicians to respond before physical symptoms occur, preventing otherwise frequent life threatening events and costly re-hospitalizations. pScreen-BNP(tm) is based on a patent-protected technology developed at Carnegie Mellon University, which has been extensively verified in our laboratory. In this Phase I proposal, we will optimize key elements of our latest pScreen-BNP(tm) prototype and complete a detailed validation study that includes positive and negative controls and patient samples collected by our clinical partners. A clinical trial and FDA 510(k) submission would then follow in a Phase II effort.

 描述（由申请方提供）：本拟定SBIR第1阶段的目的是完成新型血液检测试剂盒pScreen-BNP（tm）的临床验证，用于在家庭和床旁（POC）环境中监测和管理心力衰竭（HF）。pScreen-BNP（tm）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，价格非常实惠;它也是一种定量和灵敏的测定方法，因此它提供了HF患者血液中脑钠肽（BNP）水平的准确和精确定量。BNP是一种心脏生物标志物，当心力衰竭发作时，心脏组织会产生压力。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，并对医疗保健系统造成重大负担，每年的成本超过400亿美元。早期诊断是实现有意义的结果改变的关键。pScreen-BNP（tm）在这方面标志着HF管理的范式转变。它首次允许HF患者在临床环境之外频繁监测他们的心脏不适水平，例如在舒适的家中，类似于更熟悉的葡萄糖测试。我们的解决方案使患者及其医生能够在身体症状出现之前做出反应，从而避免频繁的危及生命的事件和昂贵的再次住院治疗。pScreen-BNP（tm）基于卡内基梅隆大学开发的专利保护技术，该技术已在我们的实验室得到广泛验证。在第一阶段的提案中，我们将优化我们最新的pScreen-BNP（tm）原型的关键要素，并完成详细的验证研究，其中包括阳性和阴性对照以及我们的临床合作伙伴收集的患者样本。随后将进行临床试验和FDA 510（k）申报， a第二阶段工作。