The National Institutes of Health (NIH) launched the Rapid Acceleration of Diagnostics (RADx) initiative to speed innovation in the development, commercialization and implementation of technologies for COVID-19 testing.
The RADx initiative is a national call for scientists and organizations to bring their innovative ideas for new COVID-19 testing approaches and strategies. Funded projects may also include new applications of existing technologies that make tests easier to use, easier to access and more accurate. At the same time, the NIH will seek opportunities to move more advanced diagnostic technologies swiftly through the development pipeline toward commercialization and broad availability — with the goal of making millions of tests per week available to Americans, particularly those most vulnerable to and/or disproportionately impacted by COVID-19, in the late summer of 2020, and having even more tests available in time for the 2020–2021 flu season.
The NIH will work to expand testing development and distribution across the country, in partnership with sibling and other government organizations such as the Biomedical Advanced Research and Development Authority, Centers for Disease Control and Prevention, Defense Advanced Research Projects Agency and U.S. Food and Drug Administration. Through this effort, the agency strives to better understand the range of testing methods and approaches through engagement with specific communities, including those in underserved areas and with vulnerable populations.
Returning safely to normal life depends on the ability to streamline and speed up the testing process. The tests must provide accurate, quick results with as few false negatives and false positives as possible. Testing must also be inexpensive, user friendly, widely accessible in a variety of settings and locations, and able to detect people who are asymptomatic. Most importantly, there is a need to understand barriers to being tested, even when tests are accessible. To meet this challenge, RADx is creating programs that will make it possible to rapidly scale-up testing across the country and enhance access to those most in need. While diagnostic testing has long been a mainstay of public health, newer technologies offer patient- and user-friendly designs that work with cellphones, for example, to lower cost and increase accessibility both at home and at the point of care.
The RADx Tech initiative aims 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 the virus. RADx Tech will expand the Point-of-Care Technologies Research Network (POCTRN) established several years ago by NIH’s National Institute of Biomedical Imaging and Bioengineering (NIBIB). The network will use a flexible, rapid process to infuse funding and enhance technology designs at key stages of development, with expertise from technology innovators, clinical testing, regulatory affairs, entrepreneurs and business leaders.
Scientists and inventors with a rapid testing technology are invited and encouraged to compete in a national “shark tank”-type COVID-19 testing challenge for a share of up to $500 million over all phases of development. The technologies will go through a highly competitive, rapid three-phase selection process to identify the best candidates for at-home or point-of-care tests for COVID-19. Finalists will be matched with technical, business and manufacturing experts to increase the odds of success. If certain selected technologies are already relatively far along in development, they can be advanced immediately to the appropriate step in the commercialization process.
The overarching goal of the RADx-UP initiative is to understand the factors associated with disparities in COVID-19 morbidity and mortality and to lay the foundation to reduce disparities for those underserved and vulnerable populations who are disproportionately affected by, have the highest infection rates of, and/or are most at risk for complications or poor outcomes from the COVID-19 pandemic. The NIH has developed community-engaged projects across the United States to assess and expand COVID-19 testing for these underserved and/or vulnerable populations, which include health disparity populations, particularly African Americans and American Indians/Alaska Natives; those in nursing homes, jails, rural areas or underserved urban areas; pregnant women; and the homeless.
Specific activities may include:
- Establishing multiple clinical research sites across the country to evaluate, in real-time, a variety of testing methods in specific populations, areas, and settings
- Encouraging collaboration between the program sites and the community — tribal health centers, houses of worship, homeless shelters, and prison systems — to identify and address their unique needs
RADx-UP will develop testing strategies to apply the technological advances emerging from the various RADx efforts in real-world settings, such as distributing home diagnostic kits.
The program will occur in two phases. The first phase will focus on communities with established research infrastructures and partnerships to 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/approved diagnostics among vulnerable populations in geographic locations that are underserved. With extensive investment in the development and validation of new testing technologies, the NIH anticipates significant changes in the landscape of testing and diagnostic approaches, as well as shifts in the pandemic itself over the next several months. Phase II of the RADx-UP initiative will be released at a later date to address developments for future community-engaged research.
RADx-rad will support new, non-traditional approaches, including rapid detection devices and home-based testing technologies, that address current gaps in COVID-19 testing. 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 current SARS-CoV-2 virus as well as potential future viruses.
Examples of non-traditional approaches include:
- Breath and community wastewater analysis to identify the virus
- Noninvasive biosensors to detect metabolites
- New analytical platforms with chemistries such as CRISPR
- Tests that detect changes in sensory or other functions to predict disease at early onset
