NIH One Step Closer to Speeding Delivery of COVID-19 Testing Technologies to Those Who Need It Most Through RADx-UP
This piece was authored in collaboration with the leadership of several institutes at NIH and represents a unified effort to meet the challenges presented by the COVID-19 pandemic with excellence and innovation.
Before the nation can safely return to business as usual, it will be essential to develop and deliver effective and reliable COVID-19 testing and then implement it widely so that it is available to everyone. The NIH is rising to this challenge through the NIH’s Rapid Acceleration of Diagnostics (RADx) initiative — a national call for scientists and organizations to advance their innovative ideas for new COVID-19 testing approaches and strategies.
To speed innovation in the development, commercialization, and implementation of technologies for COVID-19 testing, NIH will use a variety of mechanisms, including extramural grants, contracts, and cooperative agreements, to move more advanced diagnostic technologies swiftly through the development pipeline toward commercialization and widespread availability — with the goal of making millions of tests available to Americans each week, especially those most vulnerable to and disproportionately affected by COVID-19.
To achieve this goal, NIH is partnering with other government organizations including the Biomedical Advanced Research and Development Authority (BARDA), the Centers for Disease Control and Prevention (CDC), the Defense Advanced Research Projects Agency (DARPA), the Health Resources and Services Administration (HRSA), and the U.S. Food and Drug Administration (FDA).
RADx Underserved Populations (RADx-UP)
One of the four RADx components, RADx Underserved Populations (RADx-UP) will establish a network of community-engaged projects to improve access to and acceptance of COVID-19 testing for underserved and vulnerable populations who are disproportionately affected by COVID-19. This includes populations most affected by health disparities, particularly African Americans, Hispanics or Latinos, and American Indians/Alaska Natives; those in nursing homes, jails, rural areas, or underserved urban areas; pregnant women; and the homeless.
The overarching goal of RADx-UP is to understand the factors associated with disparities in COVID-19 morbidity and mortality and, ultimately, to mitigate them through enhanced access to or acceptance of testing. RADx-UP will utilize implementation science projects to learn how to increase uptake of viral testing and engagement with care in these populations, who are disproportionately affected by, have the highest infection rates of, or are most at risk for complications or poor outcomes from the COVID-19 pandemic.
Specific activities of RADx-UP may include establishing multiple clinical research sites across the country to conduct real-time evaluations of a variety of testing methods in specific populations, areas, and settings, as well as encouraging collaboration between the program sites and the community — such as tribal health centers, places of worship, homeless shelters, and prison systems — to identify and address their unique needs.
This initiative will also develop testing strategies to apply the technological advances emerging from the various RADx efforts in real-world settings.
The RADx-UP program includes four associated funding opportunity announcements.
The first funding opportunity is a limited solicitation targeting networks and consortia with established research infrastructures and community partnerships with underserved and vulnerable communities. The goal of this funding opportunity is to better understand COVID-19 testing patterns and implement strategies or interventions with the potential to rapidly increase reach, access, acceptance, uptake, and sustainment of FDA-authorized and approved diagnostics among vulnerable populations in underserved geographic locations. Proposals are due August 7, 2020.
The second funding opportunity has a similar focus, but shifts the pool of grants eligible for supplements to individual research awards that include community-collaborations or partnerships to support COVID-19 testing, or that have the capacity to ramp up quickly, to reach underserved or vulnerable populations. Proposals are due August 7, 2020 and September 8, 2020.
The third funding opportunity addresses the urgent need to understand the social, ethical, and behavioral implications of COVID-19 testing among underserved and/or vulnerable populations across the United States. The overarching goal is to understand factors that have led to disproportionate burden of the pandemic on these underserved populations so that interventions can be implemented to decrease these disparities. Proposals are due August 7, 2020 and September 8, 2020.
The final funding opportunity will fund a single organization to create a Coordination and Data Collection Center (CDCC) that will serve as a national resource, working with NIH scientific staff, and consortium members to coordinate and facilitate research activities across the programs supported by the funding opportunities identified above. Proposals are due August 7, 2020.
The other elements of RADx are:
- RADx Tech (RADx-tech) to speed the development, validation, and commercialization of innovative point-of-care and home-based tests, as well as improve clinical laboratory tests that can directly detect SARS CoV-2, the virus that causes COVID-19. Led by the National Institute of Biomedical Imaging and Bioengineering, this fast track program leverages the Point of Care Technologies Research Network (POCTRN) to stimulate the development and commercialization of innovative technologies to significantly increase the nation’s testing capacity for SARS CoV-2.
- RADx Radical (RADx-rad) to support new, non-traditional approaches, including the development of rapid detection devices and home-based testing technologies, that address gaps in current COVID-19 testing mechanisms. The program will also support new or non-traditional applications of existing approaches to make them more usable, accessible, or accurate. These may lead to new ways to identify the SARS-CoV-2 virus as well as potential future viruses. Watch for new funding announcements from this program later this summer.
- RADx Advanced Technology Platforms (RADx-ATP) to increase testing capacity and output by identifying existing and late-stage testing platforms for COVID-19 that are advanced enough to achieve rapid scale-up or expanded geographical placement in a short amount of time. These efforts will focus on scaling up technologies, including improving existing high-throughput platforms, to increase overall performance.
Want to Learn More?
If you are interested in learning more, NIH will hold two pre-application webinars. Registration is required.
- The first webinar will be held on Friday, June 26, 2020, from 2:00pm - 4:00pm EDT. This webinar will provide an overview of the RADx-UP initiative, followed by presentations on each funding opportunity (NOT-OD-20-119, NOT-OD-20-120, NOT-OD-20-121, and RFA-OD-20-013).
- The second webinar will be held on Wednesday, July 1, 2020, from 3:00pm - 5:00pm EDT. This webinar will focus on questions for applications for the Coordinating and Data Collection Center in response to RFA-OD-20-013. Questions related to the other three FOAs will also be addressed.
During this period of heightened awareness about the ways social injustices contribute to ongoing health disparities, it is essential that agencies use their mission-focused efforts to understand and, where possible, ameliorate health disparities.
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Top Row (left to right):
Diana W. Bianchi, M.D., Director, Eunice Kennedy Shriver National Institute of Child Health and Human Development
Patricia Flatley Brennan, R.N., Ph.D., Director, National Library of Medicine
Gary H. Gibbons, M.D., Director, National Heart, Lung, and Blood Institute
Joshua Gordon, M.D., Ph.D., Director, National Institute of Mental Health
Middle Row (left to right):
Richard J. Hodes, M.D., Director, National Institute on Aging
Jon R. Lorsch, Ph.D., Director, National Institute of General Medical Sciences
George A. Mensah, M.D., Division Director, National Heart, Lung, and Blood Institute
Eliseo J. Pérez-Stable, M.D., Director, National Institute on Minority Health and Health Disparities
Bottom Row (left to right):
William Riley, Ph.D., Director, NIH Office of Behavioral and Social Sciences Research
Tara A. Schwetz, Ph.D., Associate Deputy Director, National Institutes of Health and Acting Director, National Institute of Nursing Research
Nora D. Volkow, M.D., Director, National Institute on Drug Abuse