Microfluidic Nitric Oxide Sensor

微流控一氧化氮传感器

• 批准号: 9347968
• 负责人: Bruce A Cairns
• 金额: $ 72.37万
• 依托单位: CLINICAL SENSORS, INC.
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-07-01 至 2019-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9347968
• 关键词: Affect; Authorization documentation; Bacterial Infections; Benchmarking; Biochemical Markers; Biological Markers; Blood; Calibration; Caring; Cause of Death; Cessation of life; Chemicals; Clinic; Clinical; Clinical Markers; Clinical Research; Complex; Critical Illness; Critical Pathways; Detection; Devices; Diagnosis; Diagnostic; Disease; Engineering; Ensure; Functional disorder; Generations; Health Care Costs; Immune response; In Situ; In Vitro; Incidence; Infection; Intensive Care Units; Investigation; Laboratory Markers; Measurement; Measures; Methods; Microfluidics; Monitor; Morbidity - disease rate; Nitric Oxide; Organ; Pathologic; Patient Care; Patients; Performance; Phase; Population; Positioning Attribute; Pre-Clinical Model; Preparation; Production; Protocols documentation; Qualifying; Research; Research Personnel; Route; Sampling; Scientist; Sepsis; Site; Small Business Technology Transfer Research; Syndrome; System; Systemic infection; Techniques; Testing; Whole Blood; base; clinical Diagnosis; cost; imaging biomarker; improved; manufacturing process; mortality; pathogen; patient population; phase 2 study; potential biomarker; prototype; response; sensor; septic; success; tool

PROJECT SUMMARY Clinical Sensors has developed a manufacturable prototype microfluidic sensor for measuring nitric oxide in whole blood. This STTR Phase II project aims to complete several key aims necessary to commercialize this device, including a clinical study where NO levels will be evaluated clinically in sepsis. Sepsis is the leading cause of death in non-cardiac intensive care units (ICUs). Each year, sepsis affects 1.6 million people, causing 250,000 deaths and healthcare costs over $20 billion. The incidence and cost burden of sepsis are steadily increasing. Broadly defined, sepsis has been understood as a pathophysiological state in response to systemic infection by bacterial and/or fungal pathogens in blood. The definition of sepsis is continually evolving as new research emerges about this disease and clinicians seek to better manage patient care. However, the treatment paradigm remains consistent: prompt detection and action are critical for reducing sepsis-associated morbidity and mortality and reducing the costs associated with sepsis care. Currently, sepsis and its associated syndromes “lack specific clinical, imaging, laboratory, or biochemical markers with which to confirm their presence.” Nitric oxide (NO) is endogenously produced in the host response to infection, is a causative agent in sepsis-induced organ dysfunction, and has been proposed as a potential biomarker for sepsis. Until recently, no tools have existed to measure NO directly in complex matrices such as blood. We have developed a first-in- class microfluidic sensor that enables measurement of NO in whole blood. With this tool, we have demonstrated that NO levels increase rapidly in preclinical models of sepsis. In Phase I, we developed a prototype sensor, demonstrated its unprecedented analytical performance in blood, and confirmed its ability to monitor pathophysiologic NO levels in a pre-clinical model. For Phase II, we have assembled a team of scientists, engineers, and clinical researchers to complete key steps on the critical path to receiving an Investigational Device Exemption (IDE) and ultimately commercialize this device.

项目总结