SBIR Phase I: Development of a rapid, point-of-care coagulation test for the investigation and treatment of COVID-19-related coagulopathy.

SBIR 第一阶段：开发快速床旁凝血测试，用于调查和治疗 COVID-19 相关凝血病。

• 批准号: 2030771
• 负责人: Galit Frydman
• 金额: $ 25.32万
• 依托单位: COAGULO MEDICAL TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-01 至 2021-05-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2030771&HistoricalAwards=false
• 关键词: SBIR; Phase; Development; rapid; point

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is the development of a rapid, point-of-care device that allows for the precision management of blood clotting (coagulation) disorders and therapies. The proposed technology will support the development of a fully-automated reader system, along with single-use disposable cartridges, to enable clinical testing of COVID-19 patients with blood clotting issues. Due to the severe inflammation that occurs during COVID-19 disease, these patients often require frequent testing for blood clotting disorders. The proposed technology will rapidly identify patients that are more likely to form blood clots, and it can help evaluate the effectiveness of their current regimens; this will have impact beyond the current pandemic.This Small Business Innovation Research (SBIR) Phase I project allows for the determination of coagulation factor-specific inhibition and/or deficiency and real-time monitoring of response to treatment. The development of a point-of-care, portable, small volume coagulation assay that can be used for anticoagulant management using a precision-medicine approach would enable the identification of coagulation factor-specific inhibition, and, therefore, prove to be an essential tool in the diagnosis and treatment of coagulation disorders. This diagnostic would also be able to be used in non-COVID-19 anticoagulant management, aiding the identification and quantification of anticoagulants in an emergency and surgical setting and in other high-risk patients, such as neonates.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

该小企业创新研究 (SBIR) 第一阶段项目的更广泛影响/商业潜力是开发一种快速的护理点设备，可以精确管理血液凝固（凝血）疾病和治疗。 拟议的技术将支持全自动读取器系统以及一次性试剂盒的开发，以便对有凝血问题的 COVID-19 患者进行临床测试。由于 COVID-19 疾病期间发生严重炎症，这些患者通常需要频繁进行凝血障碍检测。拟议的技术将快速识别更有可能形成血栓的患者，并且可以帮助评估他们当前治疗方案的有效性；这将产生超出当前大流行的影响。这个小企业创新研究 (SBIR) 第一阶段项目可以确定凝血因子特异性抑制和/或缺陷，并实时监测治疗反应。开发一种可用于使用精准医学方法进行抗凝管理的护理点、便携式、小体积凝血测定，将能够识别凝血因子特异性抑制，因此被证明是诊断和治疗凝血障碍的重要工具。该诊断还可用于非 COVID-19 抗凝管理，帮助在紧急情况和手术环境以及新生儿等其他高危患者中识别和量化抗凝剂。该奖项反映了 NSF 的法定使命，并通过使用基金会的智力价值和更广泛的影响审查标准进行评估，被认为值得支持。