This piece was written in collaboration with the leadership of several institutes at the NIH and represents a unified effort to meet the challenges of the COVID-19 pandemic with excellence and innovation.
Before the nation can safely return to business as usual, it is important to develop and deploy effective and reliable COVID-19 tests and then implement them extensively so that they are available to everyone. The NIH addresses this challenge by rapidly accelerating the NIH’s Diagnostics (RADx). Initiative – a national call to scientists and organizations to advance their innovative ideas for new COVID-19 testing approaches and strategies.
To accelerate innovation in the development, commercialization, and implementation of technologies for COVID-19 testing, NIH will use various mechanisms, including extramural grants, contracts, and collaboration agreements, to rapidly move and advance more advanced diagnostic technologies through the development pipeline toward commercialization Availability – with the goal of providing millions of tests to Americans every week, especially those most vulnerable and disproportionately affected by COVID-19.
To achieve this goal, the NIH is working 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) and the Health Resources and Services Administration (HRSA) and the United States Food and Drug Administration (FDA).
Undersupplied RADx populations (RADx-UP)
One of the four RADx components, Undersupplied RADx populations (RADx-UP) will build a network of community-based 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 inequalities, particularly African Americans, Hispanics or Latinos, and Indians / Natives from Alaska; People in nursing homes, prisons, rural areas or underserved urban areas; pregnant woman; and the homeless.
The overarching goal of RADx-UP is to understand the factors associated with differences in the morbidity and mortality of COVID-19 and ultimately to mitigate them through improved access to or acceptance of tests. RADx-UP will use implementation science projects to learn how to increase acceptance and commitment to care in those populations that are disproportionately affected, have the highest infection rates, or are at greatest risk of complications or poor results Covid19 Pandemic.
RADx-UP’s specific activities may include setting up multiple clinical research sites across the country to perform real-time evaluations of a variety of test methods in specific populations, areas, and environments, and to encourage collaboration between program sites and the community. such as tribal health centers, places of worship, homeless shelters and prison systems – to identify and meet their special needs.
This initiative will also develop test strategies to apply the technological advances resulting from the various RADx efforts in real environments.
The RADx-UP program includes four announcements of funding opportunities.
The first financing option is limited advertising for 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 the COVID-19 test patterns and to implement strategies or interventions to increase the reach, access, acceptance, uptake and maintenance of FDA-approved and approved diagnoses in vulnerable populations underserved geographic locations can be quickly improved. The proposals are due on August 7, 2020.
The second financing option 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 ability to ramp up to undersupplied or rapid reach vulnerable populations. The proposals are due on August 7, 2020 and September 8, 2020.
The third financing option addresses the pressing need to understand the social, ethical and behavioral effects of COVID-19 testing on underserved and / or vulnerable populations in the United States. The overarching goal is to understand factors that have caused the underserved population to be disproportionately burdened by the pandemic so that measures can be taken to reduce these differences. The proposals are due on August 7, 2020 and September 8, 2020.
The last financing option will fund a single organization to create a Coordination and Data Collection Center (CDCC) that will serve as a national resource and will work with NIH academic staff and consortium members to coordinate and facilitate research activities across the programs through the above Funding opportunities are supported. The proposals are due on August 7, 2020.
The other elements of RADx are:
- RADx Tech (RADx-Tech) Accelerate the development, validation and marketing of innovative point-of-care and home tests as well as improvement of clinical laboratory tests with which SARS CoV-2, the COVID-19 virus, can be directly detected. Under the direction of the National Institute for Biomedical Imaging and BioengineeringThis Fast Track program uses the Point of Care Technologies Research Network (POCTRN). Promotion of the development and marketing of innovative technologies to significantly increase the country’s testing capacity for SARS CoV-2.
- RADx Radical (RADx-rad) Support for new, non-traditional approaches, including the development of rapid detection devices and home test technologies that fill gaps in the current COVID-19 test mechanisms. The program will also support new or non-traditional applications of existing approaches to make them more user-friendly, accessible, or accurate. This can lead to new ways to identify the SARS-CoV-2 virus as well as potential future viruses. Look out for new funding announcements from this program later this summer.
- RADx Advanced Technology Platforms (RADx-ATP) Increase in test capacity and performance by identifying existing and later test platforms for COVID-19 that are so advanced that quick scaling or expanded geographic placement can be achieved in a short time. These efforts focus on scaling technology, including upgrading existing high-throughput platforms to improve overall performance.
Would you like to learn more?
If you want to learn more, NIH will host two webinars before applying. Registration is required.
- The first webinar will take place on Friday, June 26, 2020, from 2 p.m. to 4 p.m. EDT. This webinar provides an overview of the RADx-UP initiative, followed by presentations on each funding option (NOT-OD-20-119), NOT-OD-20-120, NOT-OD-20-121and RFA-OD-20-013).
- The second webinar will take place on Wednesday, July 1, 2020, from 3 p.m. to 5 p.m. EDT. This webinar focuses on questions for applications to the Coordination and Data Collection Center in response to RFA-OD-20-013. Questions about the other three FOAs are also covered.
In this era of increased awareness of how social injustices contribute to sustained health inequalities, it is important that agencies use their task-oriented efforts to understand and improve health inequalities where possible.
Please let us know how you think we can better serve science and society.
Top row (from left to right):
Diana W. Bianchi, M.D., director, Eunice Kennedy Shriver National Institute for Child Health and Human Development
Patricia Flatley Brennan, R.N., Ph.D., director, National Library of Medicine
Gary H. Gibbons, M.D., director of the National Heart, Lung and Blood Institute
Joshua Gordon, M.D., Ph.D., Director, National Mental Health Institute
Middle row (from left to right):
Richard J. Hodes, MD, Director, National Institute of Aging
Jon R. Lorsch, Ph.D., director of the National Institute of General Medicine
George A. Mensah, MD, Head of Department, National Heart, Lung and Blood Institute
Eliseo J. Pérez-Stable, M.D., director of the National Institute for Minority Health and Health Differences
Bottom row (from left to right):
William Riley, Ph.D., director, NIH Office for Behavioral and Social Science Research
Tara A. Schwetz, Ph.D., Deputy Deputy Director, National Health Institutes and Acting Director, National Institute for Nursing Research
Nora D. Volkow, M.D., director of the National Institute on Drug Abuse