Project Summary This application is being submitted by the Colorado AMC Research Evaluation and Commercialization Hub (REACH) in response to NOT-EB-20-008, Availability of Administrative Supplements on Biomedical Technologies for Coronavirus Disease 2019 (COVID-19). The COVID-19 pandemic has had unprecedented global impact. There is an urgent need to for accelerating the development, translation, and commercialization of technologies to address COVID-19. The National Institute of Biomedical Imaging and Bioengineering (NIBIB) is seeking applications from current grantees to develop life-saving technologies that can be ready for commercialization within one to two years. The Colorado AMC REACH Hub is addressing one of the areas identified in NOT-EB-20-008, specifically, the need for rapid point-of-care and home-based testing/diagnostics. The Colorado AMC REACH Hub has received three applications from the NIH that were initially submitted to the Rapid Acceleration of Diagnostic Technologies (RADx-Tech) program, a $500 million effort to significantly increase testing capacity and accessibility for SARS-CoV-2, the virus that causes COVID-19. Many of the projects that have been submitted to RADx-Tech have been deemed too early in development or have other development challenges that have prevented them from meeting the selection criteria of increasing testing capacity by the end of 2020. The three applications that were received from the NIH were selected by the RADx- Tech program for potential supplemental funding due to their promise and their suitability for commercialization assistance to be provided by the REACH program. REACH Hubs are designed to increase the speed and success rate of translating biomedical academic discoveries into products to improve human health. Members of an external review board with extensive experience in medical diagnostic technology development reviewed the three RADx-Tech applications and approved them for acceptance into the Colorado AMC REACH Hub program. The three selected applications are: (1) Development of a point of care SARS-CoV-2 ELASA; (2) COVID-19 POC rapid antigen detection CLIA waived device; and (3) Rapid Synthetic Biology-Based Point of Care Assay for SARS-CoV-2 Virus. The requested supplemental funding will be used to fund research to advance these important projects through defined milestones and deliverables. The funding will include hiring a project management team with extensive experience in commercializing diagnostic products to work with the existing Colorado AMC REACH Hub project managers, the investigator's research team, and an NIH Entrepreneur in Residence to establish a product development plan that includes significant proof-of-concept and/or validation milestones that can be met in less than 12 months. The project management team will closely monitor progress on a regular basis with project support contingent upon satisfactory progress toward the agreed upon milestones/deliverables. The ov...