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（由适用提供）：该提出的SBIR阶段1的目的是完成新型血液测定Pscreen-BNP（TM）的临床验证，以监测家庭和护理（POC）设置中的心力衰竭（HF）。 Pscreen-BNP（TM）具有几个独特的功能。它是完全一次性的（一次性），不需要台式或手持设备，因此易于使用，而且也是一种定量和敏感的评估，因此，它在HF患者的血液中提供了精确而精确的脑NATRIARETIC PEPTIDE（BNP）水平的定量。 BNP是一种因心力衰竭发作而受到心脏组织阐述的心脏生物标志物。它因其在HF诊断方面的特异性和敏感性而广为人知。心力衰竭仍然是美国人老年人的死亡和残疾的主要原因，并且在医疗保健系统上造成了重大燃烧，成本超过400亿美元/年。早期诊断是实现有意义的结果的重要必要的必要条件。 Pscreen-BNP（TM）在这方面标记，HF管理的范式转移。它首次允许HF患者经常监测其临床环境之外的心脏病水平，例如在他们的家中，类似于更熟悉的葡萄糖测试。我们的解决方案使患者及其医生在身体症状发生之前能够做出反应，以防止其他经常威胁生命的事件并重新住院。 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中得到了广泛的验证。在此阶段I提案中，我们将优化最新的Pscreen-BNP（TM）原型的关键要素，并完成一项详细的验证研究，其中包括我们临床伙伴收集的阳性和阴性对照和患者样本。然后将进行临床试验和FDA 510（k）提交 第二阶段的努力。