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Venous Thromboembolism Risk Marker Assay

静脉血栓栓塞风险标记测定

基本信息

批准号：
8249829
负责人：
DAVID Henry FARRELL
金额：
$ 52.03万
依托单位：
GAMMA THERAPEUTICS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-08-15 至 2014-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8249829
关键词：
Amendment American Society of Hematology Anticoagulant therapy Antithrombins Biological Assay Biological Markers Blood Blood Clot Blood coagulation Businesses Clinical Clinical Management Coagulation Process Communities Deep Vein Thrombosis Detection Development Diagnosis Diagnostic Disease Doctor of Philosophy Enzyme-Linked Immunosorbent Assay Evaluation Fibrinogen Gene Mutation Goals Gold Grant Guidelines Hematology Individual Institutes International Journals Laboratories Length Letters Malignant Neoplasms Measurement Measures Medicine Menstruation Messenger RNA Methods Monoclonal Antibodies National Heart, Lung, and Blood Institute Normal Range Oral Contraceptives Patients Pennsylvania Performance Phase Physicians Plasma Pregnancy Prevention therapy Process Production Protein C Deficiency Protein Isoforms Protein S Deficiency Proteins Prothrombin Publishing Reagent Recurrence Request for Proposals Research Review Literature Risk Risk Assessment Risk Factors Risk Marker Sampling Sensitivity and Specificity Technology Technology Transfer Testing Therapeutic Thromboembolism Thrombophilia Time Triad Acrylic Resin United States Food and Drug Administration Universities Venous base college design factor V Leiden forging genetic risk factor high throughput screening improved insight interest non-genetic novel programs public health relevance scale up

项目摘要

DESCRIPTION (provided by applicant): The application's broad, long-term objectives are to develop a rapid, high-throughput clinical assay for 3' fibrinogen that will be used to assess the risk of a patient developing venous thromboembolism. This assay will guide clinical management, particularly the use of long-term anticoagulant therapy for patients. The utility of this assay will be the identification of patients at risk for developing venous thromboembolism who should be anticoagulated, and conversely, identification of patients at low risk of developing venous thromboembolism who should not be subjected to the possible dangers of anticoagulant therapy. The specific aim of Phase I of this Fast-Track application is to: 1) Develop a rapid, high-throughput assay for 3' fibrinogen. This will be accomplished using our proprietary monoclonal antibody, 2.G2.H9, and the Luminex xMAP(R) technology platform. The milestones for the successful completion of Phase I and transition to Phase II are to develop a 3' fibrinogen assay that measures the normal range of 3' fibrinogen in plasma from 0-1.5 mg/ml, and achieves a standard curve fit with an R2 accuracy of >0.95. In Phase II, the Specific Aims are to: 2) Validate the 3' fibrinogen assay. The assay will be evaluated for linearity, interference testing, method comparison, bias estimation, and comparison to the previous plate-based ELISA in test samples using guidelines published by the Clinical and Laboratory Standards Institute (CLSI) for precision performance of quantitative measurement methods. This information will be essential for Food and Drug Administration (FDA) and Clinical Laboratory Improvement Amendments (CLIA) evaluation of the assay; 3) Quantitate the intra-individual variability of 3' fibrinogen levels over time. This will be accomplished by measuring 3' fibrinogen levels in individuals at weekly time points over a 3-month period and monthly time points over a one-year period to determine the within-subject variability. This information will be critical for widespread acceptance of the assay by clinical laboratories; 4) Scale up production of the assay kit components. This will be accomplished with assistance from the Office of Technology Transfer & Business Development at OHSU, which has forged ties with the entrepreneurial and local business community to create a framework of support for the development of companies utilizing OHSU research. Their Springboard Program is designed to catalyze the development of new ventures based on OHSU technologies. We have already attracted the interest of Diagnostica Stago, a major international coagulation diagnostics company. PUBLIC HEALTH RELEVANCE: This proposal is to develop a rapid, high-throughput clinical assay for 3' fibrinogen, a newly-emerging risk factor for venous thromboembolism. This assay will be used by physicians for risk assessment of venous thromboembolism, and will guide their clinical management, particularly their use of anticoagulant therapy in patients. Information gained from the use of this assay will identify patients at risk for deep vein thrombosis who should be anticoagulated, and conversely, will identify patients at low risk of venous thromboembolism who should not be subjected to anticoagulant therapy.

描述（由申请人提供）：该申请的广泛、长期目标是开发一种快速、高通量的3'纤维蛋白原临床检测方法，用于评估患者发生静脉血栓栓塞的风险。该检测将指导临床管理，特别是对患者使用长期抗凝治疗。该测定的效用将是识别具有发生静脉血栓栓塞风险的患者，这些患者应接受抗凝治疗，相反，识别具有发生静脉血栓栓塞低风险的患者，这些患者不应遭受抗凝治疗的可能危险。该快速通道申请的I期的具体目标是：1）开发用于3'纤维蛋白原的快速、高通量测定。这将使用我们专有的单克隆抗体2.G2.H9和Luminex xMAP（R）技术平台来完成。成功完成I期和过渡到II期的里程碑是开发3'纤维蛋白原测定法，其测量血浆中0-1.5 mg/ml的3'纤维蛋白原的正常范围，并实现R2准确度>0.95的标准曲线拟合。在II期，具体目标是：2）3'纤维蛋白原测定。将使用临床和实验室标准化协会（CLSI）发布的定量测量方法精密度性能指南，评价检测试剂盒的线性、干扰试验、方法比较、偏倚估计以及与供试样本中先前平板ELISA的比较。该信息对于美国食品药品监督管理局（FDA）和临床实验室改进修正案（CLIA）对测定法的评价至关重要; 3）定量3'纤维蛋白原水平随时间的个体内变异性。这将通过在3个月期间的每周时间点和1年期间的每月时间点测量个体中的3'纤维蛋白原水平以确定受试者内变异性来实现。该信息对于临床实验室广泛接受该测定将是至关重要的; 4）按比例扩大测定试剂盒组分的生产。这将在OHSU技术转让和业务发展办公室的协助下完成，该办公室与企业家和当地企业界建立了联系，为利用OHSU研究的公司的发展建立了支持框架。他们的跳板计划旨在促进基于OHSU技术的新企业的发展。我们已经吸引了国际主要凝血诊断公司Diagnostica Stago的兴趣。公共卫生相关性：本研究旨在建立一种快速、高通量的3'纤维蛋白原临床检测方法。医生将使用该测定进行静脉血栓栓塞的风险评估，并将指导其临床管理，特别是在患者中使用抗凝治疗。通过使用该检测试剂盒获得的信息将识别出有深静脉血栓形成风险且应接受抗凝治疗的患者，反之，将识别出静脉血栓栓塞低风险且不应接受抗凝治疗的患者。