By Dr. Dan Regan

The Council on Strategic Risks (CSR) hosted a webinar on June 8 titled RADx® Initiative & COVID-19 Solutions: Bioengineering at Unprecedented Speed and Scale. As COVID-19 continues to spread and new variants of concern emerge, testing remains an important public safety tool. In the United States, a critical component of testing is at-home testing kits which the Biden Administration has been making available and distributing for all U.S. residences. This RADx Initiative, an NIH-based program, was critical in the shift from solely laboratory-based testing to the public-private partnership that enabled the production and accessibility of point-of-care (POC) and over-the-counter (OTC) COVID-19 tests. (see a video of the event below).

CSR’s CEO Christine Parthemore opened the webinar and served as the event’s moderator. She highlighted the unprecedented undertaking that the RADx program took on during the pandemic, as few previous government programs have engaged the private sector in addressing diagnostics for infectious disease threats and delivered results at the scale that this initiative accomplished. The public buy-in to use POC rapid COVID tests was a true paradigm shift in how infectious diseases are detected and is an effort that should continue for future outbreaks. Parthemore then turned the webinar over to three of the key architects of the RADx program to share lessons from their experiences.

Dr. Bruce Tromberg, Director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) at the National Institutes of Health (NIH), and Co-Chair of the RADx Tech Working Group, provided insights on the scope of RADx’s tasking. 

When RADx was launched in April 2020, its goal was to transition from sole reliance on what were then 7.5 million laboratory-based tests per month to producing and delivering tens of millions of POC and OTC tests to public health centers and individual homes. By tapping into the NIBIB’s existing POC Technology Research Network, more than 900 experts and contributors were brought onboard to accomplish this moonshot task. 

By February 2022, laboratory-based tests represented approximately 12% of total testing, demonstrating the nearly complete shift to POC testing – an indicator that a paradigm shift from lab testing to POC and OTC testing was established for COVID-19. As of April 2022, POC and OTC testing capacity surged to 330 million tests and products produced per month with 44 Emergency Use Authorizations granted. 

Dr. Jill Heemskerk, Deputy Director of NIBIB and Co-Chair of the RADx Tech Working Group discussed the group’s recent effort to make OTC tests more accessible to all users. Dr. Heemskerk’s efforts in this area began with listening sessions with advocacy groups and communities representing the blind and visually impaired (BVI), those with fine motor skill impairments, and the elderly population. These sessions were attended by several federal agencies, including the NIH, CDC, FDA, Administration on Community Living, and the U.S. Access Group. They raised challenges of OTC tests such as limited options for testing instructions for the BVI community, dexterity issues for performing the sample preparation due to the small size of these devices and their component parts, and the accessibility limitations of using smartphone applications for certain populations. This work has resulted in 25 POC devices being evaluated for accessibility modifications, with a turnaround time between 3-18 months. Furthermore, these conversations have led RADx leaders to account for accessibility issues during long-term planning for POC tests from the start of the engineering design cycle. 

Dr. Rachael Fleurence, who served as the Senior Advisor in the Immediate Office of the Director at the NIH and as the Special Assistant to the NIH Director for COVID-19 Diagnostics, highlighted the Say Yes! Covid Test program, of which she was Co-Chair. This venture was a joint program between the CDC and the NIH with the goal of providing at-home COVID-19 tests to individuals and families in targeted geographic areas. Tests were distributed by local public health authorities, community-based organizations, or through online orders.

Since launching in March 2021, more than 6.8 million tests were distributed through this specific program, with about 1/3 in-person and 2/3 via web requests. One of the anecdotes from this program is that while overall test result reporting from end-users was low, ~80% of those who used the mobile application reported their test results. The Say Yes! Covid Test venture highlighted how at-home testing has garnered public buy-in, indicating that the NIH and other agencies should prepare for this trend to continue for future infectious disease events. 

Following their discussion, the webinar shifted to a Q&A session. Below are some important lessons these questions raised:

• RADx took the existing scaffolding of the NIH POC Technology Research Network and actively engaged with innovators in the bioindustrial base to tap into the public-private ecosystem. 
• RADx demonstrated that government programs are able to take on dynamic and agile management mechanisms to deliver products at unprecedented scales in times of national crisis.
• Replicating the RADx model in other efforts will require innovation in funding mechanisms for new diagnostic platforms tailored for the emerging threat. This includes the government’s role in the short-term scale-up of tailored products for both mass manufacture and delivery.
• RADx developed the framework and data standardization for universal reporting of at-home test results. Further work is needed, including how to convey the importance and reasoning of public health actions to citizens, as well as creating a single entry point for test reporting. 

The webinar concluded with the experts sharing what their hopes are for the future of RADx. Those sentiments included expanding research on test technology that have lower limits of detection to narrow the window of when an active infection can be detected, continuing the blueprint laid by RADx for future NIH applications with continuous engagement of program producers, and the ability for the government to step in and fund technology that the bioindustrial base won’t invest in.

CSR views RADx as one initiative where the U.S. government has demonstrated flexibility to create an effective public-private partnership model. This created a paradigm shift such that there is now public buy-in for at-home testing during infectious disease outbreaks. RADx successes and lessons learned should be used as a blueprint for future outbreaks and public health endeavors to engage with the bioindustrial base for the rapid development of critical public health products.

A recording of the webinar can also be found here.