Automated Molecular Diagnostics for Rapid Detection of Dengue Viremia Using Whole

DESCRIPTION (provided by applicant): We propose to develop a highly sensitive and rapid point-of-care nucleic acid test based on IQuum's lab-in-a-tube (Liat ) platform for the diagnosis of patients with dengue fever or dengue hemorrhagic fever from whole blood samples. The Liat Dengue Assay will utilize the Liat Analyzer to enable the minimally trained personnel to perform the dengue infection test at a hospital, clinic or physician's office in less than 1 hour. By enabling effective and sensitive dengue infection testing, we expect that the Liat assay will allow clinicians to quickly diagnose patients with dengue fever or dengue hemorrhagic fever and initiate appropriate treatments. The Liat Dengue Assay overcomes the limitations of current dengue infectiontests, whose long turnaround time and technical complexity requires testing to be performed in centralized laboratories, resulting in missed opportunities for disease treatment or the continued use of ineffective treatment regimens. The assay will also beamong the first near patient nucleic acid tests, and will provide significant benefit to patient health and welfare, as well as enhance the preparedness for this emerging disease. In Phase I, we propose to transfer the Liat Dengue Assay to manufacturingand perform analytical sensitivity and specificity studies. In Phase II, we propose to complete the analytical studies, develop and validate manufacturing processes for the Liat Dengue Assay, and conduct clinical sample study to validate the assay. At theconclusion of the pre-clinical and analytical studies, we will submit a pre-investigational device exemption (pre-IDE) to the FDA in preparation for expanded clinical study of the Liat Dengue Assay for 510(K) market clearance. PUBLIC HEALTH RELEVANCE: By enabling effective and sensitive dengue infection testing, the Liat Dengue Assay will allow clinicians to quickly diagnose patients with dengue fever or dengue hemorrhagic fever. The Liat Dengue Assay overcomes the limitations of current dengue infection tests, whose long turnaround time and technical complexity requires testing to be performed in centralized laboratories, resulting in missed opportunities for disease treatment or the continued use of ineffective treatment regimens. The assay will also be among the first near patient nucleic acid tests, and will provide significant benefit to patient health and welfare, as well as to enhance the preparedness for this emerging disease.