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（由申请人提供）：拟议的 SBIR 第一阶段的目标是完成新型血液检测 pScreen-BNP(tm) 的临床验证，用于家庭和护理点 (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（一次性使用），不需要台式或手持设备，因此易于使用且价格非常实惠；它也是一种定量且灵敏的检测方法，因此可以准确、精确地定量心衰患者血液中脑钠肽 (BNP) 的水平。 BNP 是心脏组织在因心力衰竭发作而受到压力时产生的一种心脏生物标志物。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，给医疗保健系统带来了沉重负担，每年的费用超过 400 亿美元。早期诊断对于实现有意义的结果改变至关重要。 pScreen-BNP(tm) 在这方面标志着心力衰竭管理的范式转变。它首次允许心力衰竭患者在临床环境之外（例如在医院）经常监测他们的心脏窘迫程度。在舒适的家中进行，类似于更熟悉的血糖测试。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，从而防止频繁发生危及生命的事件和昂贵的再住院治疗。 pScreen-BNP(tm) 基于卡内基梅隆大学开发的受专利保护的技术，该技术已在我们的实验室得到广泛验证。在此一期提案中，我们将优化最新 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并提交 FDA 510(k) 第二阶段的努力。