Colorado REACH Hub

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 BiomedicalTechnologies for Coronavirus Disease 2019 (COVID-19). The COVID-19 pandemic has had unprecedentedglobal impact. There is an urgent need to for accelerating the development, translation, and commercializationof 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 forcommercialization within one to two years. The Colorado AMC REACH Hub is addressing one of the areasidentified 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 theRapid Acceleration of Diagnostic Technologies (RADx-Tech) program, a $500 million effort to significantlyincrease testing capacity and accessibility for SARS-CoV-2, the virus that causes COVID-19. Many of theprojects that have been submitted to RADx-Tech have been deemed too early in development or have otherdevelopment challenges that have prevented them from meeting the selection criteria of increasing testingcapacity 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 commercializationassistance to be provided by the REACH program. REACH Hubs are designed to increase the speed andsuccess rate of translating biomedical academic discoveries into products to improve human health. Membersof an external review board with extensive experience in medical diagnostic technology development reviewedthe three RADx-Tech applications and approved them for acceptance into the Colorado AMC REACH Hubprogram. 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 ofCare Assay for SARS-CoV-2 Virus. The requested supplemental funding will be used to fund research toadvance these important projects through defined milestones and deliverables. The funding will include hiring aproject management team with extensive experience in commercializing diagnostic products to work with theexisting Colorado AMC REACH Hub project managers, the investigator's research team, and an NIHEntrepreneur in Residence to establish a product development plan that includes significant proof-of-conceptand/or validation milestones that can be met in less than 12 months. The project management team will closelymonitor progress on a regular basis with project support contingent upon satisfactory progress toward the agreedupon milestones/deliverables. The overall goal is to advance the projects to an inflexion point wherein thetechnology can be licensed to an existing or new company to further develop the commercial applications.