SBIR Phase I: Automated DOAC assay to determine coagulation status in emergent care

SBIR 第一阶段：自动 DOAC 测定以确定紧急护理中的凝血状态

• 批准号: 2035983
• 负责人: Mark Kunkel
• 金额: $ 25.6万
• 依托单位: FLOBIO LLC
• 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: 2020-12-01 至 2023-03-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2035983&HistoricalAwards=false
• 关键词: SBIR; Phase; Automated; DOAC; assay

The broader impact/commercial impact potential of this Small Business Innovation Research (SBIR) Phase 1 project is a diagnostic product that addresses patient safety and clinical decision-making for physicians managing patients taking Direct Oral Anticoagulants (DOACs). DOACs are becoming the preferred drugs to reduce the risk of blood clots that can lead to significant adverse events, such as stroke. However, DOACs are part of the leading class of drugs implicated in adverse event-related emergency department visits. These adverse events place a significant burden on the healthcare system in the form of transfusions, exposure to blood products, platelet repletion, reversal therapies, and additional complications (e.g. infection, sepsis, multiple organ failure) driving longer hospitalizations, higher mortality rates, and escalating healthcare costs. In emergency situations, the rapid detection of DOAC anticoagulation is needed when planning for urgent care for surgery, serious trauma, drug overdose, emergency procedures, or monitoring for drug accumulation in cases of renal and liver failure. This project proposes a diagnostic at the point of care. With an estimated 21 M patients globally taking DOACs, this technology could significantly reduce the $2.5 B in costs related to treating and correcting adverse events caused by the absence of DOAC information in emergency care situations. This Small Business Innovation Research (SBIR) Phase I Project will demonstrate the feasibility of a point-of-care (POC) diagnostic chip for emergency room clinicians to manage bleeding risk and avoid overuse of drug reversal therapies, thereby improving patient outcomes while reducing healthcare costs. Currently there is no approved rapid diagnostic POC test that accurately identifies the type of DOAC drug a patient is using, nor how much of the drug is in the patient’s blood. An integrated microfluidic cartridge is proposed developed to manage blood distribution within the device, mix the blood with DOAC detection reagents, and provide an integrated assay result that evaluates the three important clotting factors in clot formation (fibrin/thrombin/platelets). The technology is unique in that, unlike other coagulation tests, it re-creates the blood clotting physiology, and characteristic blood flow, that happens within the body. With DOAC-reversing drugs, the diagnostic can determine DOAC type (Factor Xa or Factor IIa), and the level of DOAC in the blood, allowing emergency room physicians to make more informed care decisions.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.

这项小型企业创新研究（SBIR）第1期项目的更广泛的影响/商业影响潜力是一种诊断产品，可针对管理直接口服抗凝剂（DOAC）的患者的患者安全和临床决策。 DOAC正在成为降低血凝块风险的首选药物，这些药物可能导致严重的不良事件，例如中风。但是，DOAC是在与不良事件有关的急诊科实施的领先药物的一部分。这些不良事件以翻译，血液产品的暴露，血小板替代品，反向疗法和其他并发症（例如感染，败血症，多器官衰竭）驱动更长的住院，较高的死亡率以及升级医疗保健成本的其他并发症（例如感染，败血症，多器官衰竭）对医疗保健系统造成了重大燃烧。在紧急情况下，在计划手术，严重的创伤，药物过量，紧急程序或在肾脏衰竭病例中监测药物积累时，需要快速检测DOAC抗凝治疗。据估计，全球服用DOAC的患者估计有21 m，这项技术可能会大大降低与治疗和纠正不在急诊状况中的DOAC信息有关的不良事件有关的2.5 b美元的成本。这项小型企业创新研究（SBIR）I阶段项目将证明急诊室临床医生的服务点（POC）诊断芯片的可行性，以管理出血风险并避免过度使用药物逆转疗法，从而改善患者的预后，同时降低医疗保健费用。目前尚无批准的快速诊断POC测试，可以准确地识别患者使用的DOAC药物类型，也可以确定患者血液中的药物中有多少。提出了一个集成的微流体墨盒，以管理设备内的血液分布，将血液与DOAC检测试剂混合，并提供集成的测定结果，以评估凝块形成中三个重要的服装因子（纤维蛋白/凝血酶/血小板/血小板）。该技术是独一无二的，因为与其他凝血测试不同，它重新创建了体内发生的血液服装生理和特征性血流。借助DOAC逆转药物，诊断可以确定DOAC类型（因子XA或因子IIA）以及血液中的DOAC水平，使急诊室医生能够做出更明智的护理决定。这项奖项反映了NSF的法定任务，并通过评估该基金会的智力功能和广泛的影响来评估CRETERIA CREITERIA。