SBIR Phase I: CoagCare-A POC Blood Coagulation Diagnostic Platform That Utilizes A Hand-held Meter and Mechanically Sensitive Test Strips for Broad Spectrum Hemostasis Monitoring

SBIR 第一期：CoagCare - POC 凝血诊断平台，利用手持式仪表和机械敏感试纸条进行广谱止血监测

• 批准号: 1935404
• 负责人: Ramkumar Abhishek
• 金额: $ 22.5万
• 依托单位: Abram Scientific, Inc.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-10-15 至 2020-06-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1935404&HistoricalAwards=false
• 关键词: SBIR; Phase; CoagCare; POC; Blood

The broader/commercial impact of this SBIR Phase I project will commercialize a new technology for accurate, portable, and inexpensive measurement of blood clotting tests routinely performed on patients who suffer from conditions such as atrial fibrillation, deep vein thrombosis, or have a mechanical heart valve replacement. These conditions affect millions of patients in the US alone in an annual market worth more than $3 B worldwide. However, many of the state-of-practice technologies cannot accurately or conveniently perform multiple blood clotting tests on the same system, causing clinically significant problems for patients and raising the cost and inconvenience of routine testing. The technology in this project fundamentally enables these various blood clotting tests to be performed in a single portable, test-strip system. This will potentially lead to cheaper and more convenient blood clot testing for medical professionals and millions of patients; improve medical care by bringing accurate and multiple blood clotting tests to a single portable device; bring competition to devices which rely on older technologies; and foster small business and job growth in an emerging technology landscape that has the potential to address a 3 billion dollar, worldwide market. The proposed project will enable the first-of-its-kind implementation of a point of care (POC) direct, mechanical test in a meter and strip format, to more closely replicate the mechanical methods which fundamentally underlie all blood clotting tests in the clinical laboratory. As a mechanical measurement, the strip will measure physical properties of the clotting whole blood sample and account for the confounding factors affecting point of care blood clotting tests, such as hematocrit for prothrombin time / international normalized ratio measurement. As a broad-spectrum hemostasis platform technology, multiple blood coagulation tests can be brought to the portable point of care format, including thromboelastography (TEG), activated partial thromboplastin time (aPTT), activated clotting time (ACT), and prothrombin time / international normalized ratio (PT/INR) tests. This SBIR Phase I project will demonstrate the feasibility of a commercial blood coagulation test, realizing a mechanical, strip-based, portable POC blood coagulation platform system.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SBIR I期项目的更广泛/商业影响将使一项新技术商业化，以准确，便携式和廉价的测量血液凝结测试，这些测试通常对患有心房颤动，深静脉血栓形成或机械心脏瓣膜替代的患者进行。这些条件仅在全球价值超过3美元的年度市场上就影响了美国数百万的患者。但是，许多实践技术技术无法准确或方便地在同一系统上进行多次血液凝结测试，从而导致患者临床上的重要问题，并提高常规测试的成本和不便。该项目中的技术从根本上使这些各种血液凝结测试能够在单个便携式测试条纹系统中进行。这可能会导致对医学专业人员和数百万患者的便宜，更方便的血块测试；通过将准确和多个血液凝结测试带入单个便携式设备来改善医疗保健；将竞争带入依靠旧技术的设备；并在新兴的技术格局中促进小型企业和工作增长，有可能解决30亿美元的全球市场。拟议的项目将使以仪表和条格式的直接进行护理点（POC）直接测试的初始实施，以更紧密地复制临床实验室中所有血液凝结测试基础的机械方法。作为一种机械测量，条带将测量凝结全血样品的物理特性，并解释影响护理血液凝结测试的混杂因素，例如针对凝血酶蛋白时间 /国际归一化比率测量的血细胞比容。作为一种广谱止血平台技术，可以将多种血液凝结测试带到便携式的护理点格式，包括血栓骨头学（TEG），激活的部分血栓层蛋白时间（APTT），激活的凝胶凝结时间（ACT）和凝血酶蛋白时间 /国际标准化比率（PT / INR）测试。这个SBIR I期项目将证明商业血液凝结测试的可行性，实现了一个机械，基于剥离的，可移植的POC血液凝结平台系统。该奖项反映了NSF的法定任务，并被认为是值得通过基金会的知识分子优点和更广泛影响的审查标准来评估的。