A NOVEL POINT-OF-CARE PLATELET FUNCTION ANALYZER

描述（由申请方提供）：冠心病（CHD）和卒中仍然是美国发病率和死亡率的主要原因之一，血小板在CHD/卒中中起主要作用。因此，使用抗血小板药物有助于预防或治疗此类血管疾病。尽管大量患者常规使用抗血小板药物，但抗血小板治疗的疗效很少在每位患者中进行监测。大多数患者的处方是固定剂量，没有努力建立治疗效果，缺乏适当的策略，排除了个体监测和剂量调整，以确保充分的保护。多达30%的患者可能对标准剂量的常用抗血小板药物（如阿司匹林和氯吡格雷）耐药，这进一步强调了监测抗血小板治疗的必要性。目前用于评估血小板功能的方法繁琐且耗时（实验室方法），或相对昂贵、不可靠，并且仅提供间接/不完整的测量（目前的即时护理仪器），因此缺乏灵敏度。Thrombodyne Inc.在NIH的资助下，开发了一种评估全血中血小板功能的新方法。Thrombodyne血小板功能分析仪（TPFA）的功能版本经受住了严格的实验室和有限的临床测试，检测血小板功能异常，并确定可能对标准剂量的抗血小板药物耐药的患者。通过这项申请，研究人员要求支持以维持他们的努力：1）使TPFA成为一种具有成本效益，方便和多功能的床旁仪器，2）寻求FDA批准以准备上市，3）证明个体定制的抗血小板药物（或药物组合）剂量将导致更好的治疗效果，减少副作用，并产生更好的结果。申请人正处于其发展道路上的一个独特点，申请的资金将使他们能够将设备推向市场。这种方便，具有成本效益的即时血小板功能分析仪的引入将使为每个人量身定制抗血小板治疗并改善结果成为可能。

DESCRIPTION (provided by applicant): Coronary heart disease (CHD) and stroke remain 1 of the major causes of morbidity and mortality in the US, and platelets play a major role in CHD/stroke. Thus, the use of antiplatelet drugs is helpful in the prevention or treatment of such vascular disorders. Despite routine use of antiplatelet agents in a large number of patients, the efficacy of antiplatelet therapy is rarely monitored in each patient. Most patients are prescribed a fixed dose with no effort to establish therapeutic efficacy, and the lack of suitable strategies precludes individual monitoring and adjustment of dosage to ensure adequate protection. The need for monitoring antiplatelet therapy is further accentuated by the fact that as many as 30% of patients may be resistant to standard dosages of commonly used antiplatelet drugs such as aspirin and clopidogrel. The current methods for the assessment of platelet function are cumbersome and time-consuming (laboratory methods), or relatively expensive, unreliable and offer only an indirect/incomplete measure (current point-of care instruments), and therefore lack sensitivity. Thrombodyne Inc. has developed, with funding from NIH, a novel approach to assess platelet function in whole blood. A functional version of the Thrombodyne Platelet Function Analyzer (TPFA) has withstood the rigors of laboratory and limited clinical testing, and detects platelet function abnormalities and identifies patients who may be resistant to standard doses of antiplatelet agents. Through this application, the investigators request support to sustain their efforts to: 1) make TPFA a cost-effective, convenient and versatile point-of-care instrument, 2) to seek FDA approvals to prepare it for marketing, and 3) to demonstrate that individually tailored dosing of antiplatelet agent (or combination of agents) would lead to better therapeutic efficacy, reduce side effects, and result in better outcomes. The applicants are at a unique point in their development path where the requested funding would allow them to take the device to market. The introduction of this convenient, cost-effective point-of-care platelet function analyzer would make it possible to tailor antiplatelet therapy for each individual and improve outcomes.