Lab-in-a-tube test for cytomegalovirus monitoring

描述(申请人提供)：我们建议开发一种基于IQuum的Lab-in-a-Tube(LiatTM)平台的快速核酸检测方法，用于巨细胞病毒(CMV)的定量检测，用于移植患者的监测。LiatTM CMV检测将利用LiatTM Analyzer，使任何医院或移植中心都能在1小时内进行全自动和随机访问的CMV病毒载量测试。通过实现快速和定量的CMV检测，我们预计Liat检测将使移植临床医生能够更有效地监测CMV感染并实施适当的治疗，以改善移植结果和患者的整体健康。该项目的成果将解决目前缺乏FDA批准的定量CMV检测的问题，并克服国内BREW CMV检测的局限性，这些检测的周转时间长、手动操作、技术复杂且缺乏标准化，对移植应用来说是非常困难的。 在这个项目的第一阶段，我们已经证明了在Liat分析仪上定量检测血浆中CMV的概念。在第二阶段的竞争更新中，我们打算完成样品对结果定量Liat CMV检测的开发和优化。我们还打算在一项临床前研究中确定和验证这一检测方法，并启动一项多点研究研究，以检测和监测移植受者的CMV DNA。在这个项目结束时，我们预计将准备申请FDA的上市前批准(PMA)。该检测有望成为首个用于移植应用的PMA合格的CMV定量检测方法，并将为移植中心和患者带来显著的好处。利用IQuum的LiatTM Analyzer，LiatTM CMV检测将成为FDA批准的第一个用于移植患者监测的定量CMV测试。该测试将使任何医院或移植中心能够在1小时内进行全自动和随机访问的CMV病毒负载测试，从而克服目前家用BREW测试的局限性，这些测试的周转时间长、手动操作、技术复杂和缺乏标准化，对于移植应用来说是非常困难的。Liat检测将使移植临床医生能够更有效地监测CMV感染并实施适当的治疗，以改善移植结果和患者的整体健康。

DESCRIPTION (provided by applicant): We propose to develop a rapid nucleic acid test based on IQuum's lab-in-a-tube (LiatTM) platform for the quantitative detection of cytomegalovirus (CMV) for transplant patient monitoring. The LiatTM CMV Assay will utilize the LiatTM Analyzer to enable any hospital or transplant center to perform fully automated and random access CMV viral load tests in 1 hour. By enabling fast and quantitative CMV testing, we expect that the Liat assay will allow transplant clinicians to more effectively monitor CMV infection and implement appropriate therapies to improve transplant outcomes and overall patient health. The outcome of this project will address the current lack of an FDA approved quantitative CMV assay and overcome the limitations of home brew CMV tests, whose long turnaround time, manual operation, technical complexity and lack of standardization, is highly problematic for transplant applications. In Phase I of this project, we have proven the concept of quantitatively detecting CMV from plasma on the Liat Analyzer. In this Phase II Competitive Renewal, we intend to complete the development and optimization of a sample-to-result quantitative Liat CMV Assay. We further intend to characterize and validate the assay in a pre-clinical study, and initiate a multi-site research study to detect and monitor CMV DNA in transplant recipients. At the conclusion of this project, we expect to be prepared to file for FDA Pre-market approval (PMA). The assay is expected to be the first PMA cleared quantitative CMV test for transplant application, and will provide significant benefit to transplant centers and patients. Utilizing IQuum's LiatTM Analyzer, the LiatTM CMV Assay will be the first FDA approved quantitative CMV tests for transplant patient monitoring. The assay will enable any hospital or transplant center to perform fully automated and random access CMV viral load tests in 1 hour, thus overcoming the limitations of current home brew assays, whose long turnaround time, manual operation, technical complexity and lack of standardization, is highly problematic for transplant applications. The Liat assay will enable transplant clinicians to more effectively monitor CMV infection and implement appropriate therapies to improve transplant outcomes and overall patient health.