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.