Lab-in-a-tube test for cytomegalovirus monitoring

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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.