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Principal Investigator: RICHARD C DUKE
Organization: UNIVERSITY OF COLORADO DENVER
Fiscal Year: 2020
Award: $1,166,125
Funding agency: National Heart Lung and Blood Institute
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 overall goal is to advance the projects to an inflexion point wherein the
technology can be licensed to an existing or new company to further develop the commercial applications.
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