What's next for RADx? The NIH drafts a to-do list for its $1.5B diagnostics competition, through COVID and beyond

In the spring of 2020, as the COVID-19 pandemic crashed like a tsunami into every aspect of life as we knew it, the National Institutes of Health (NIH) scrambled to build a dam.

It took the form of the Rapid Acceleration of Diagnostics initiative, or RADx, a “Shark Tank”-like competition to develop and commercialize COVID tests as quickly as possible, backed by $1.5 billion in government funding.

It worked: True to the proposed timeline, the first medtech and biotech developers chosen in the competition were able to validate and deploy hundreds of millions of coronavirus diagnostics by the following fall. The initiative has only continued to ramp up in the year since, with dozens more companies scoring RADx funding to further refine COVID testing tools and processes.

And it’s showing no signs of slowing down anytime soon. During a panel discussion about the initiative at AdvaMed’s annual MedTech Conference on Tuesday, Bruce Tromberg, Ph.D., director of the NIH’s National Institute of Biomedical Imaging and Bioengineering, outlined what’s next for RADx, which was built upon the institute's existing Point-of-Care Technologies Research Network.

Top of mind is the process of ensuring tests that have come through the RADx pipeline are able to identify variants of the coronavirus as accurately as the original strain. To that end, a multiagency, multidisciplinary effort is already underway, Tromberg said, with the NIH, the FDA and others now expanding beyond those validation efforts to also design real-time surveillance tests and tools that can immediately spot and track new mutations of the virus.

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RADx is also hoping to bridge the gap between RT-PCR lab tests and over-the-counter antigen tests for COVID. Though a recent study by RADx researchers found that antigen tests can achieve results comparable to “gold standard” PCR tests if used repeatedly every few days, their accuracy levels drop dramatically when used as a one-off diagnostic.

The NIH’s solution? Increased investments in next-generation technologies like microfluidics, synthetic biology, CRISPR gene editing, spectroscopy and nanomaterials, the last of which make up nearly 20% of the projects that have made it to phase two of the RADx competition, according to Tromberg.

Meanwhile, RADx is simultaneously working on expanding the potential of the tests that it’s already brought to market, partnering with the FDA to dish out new authorizations allowing them to be used as mass screening tools and on pooled samples, and even to be self-administered by children, reducing the need for adults or clinical staff to perform every test in crowded school settings.

That’s far from the end of RADx’s to-do list.

“As we see increasing vaccination and increasing variants, we need to do better. We need more sensitive and accessible tests, we need multiplex tests—COVID with flu, RSV and other pathogens—and to expand our digital health reporting,” Tromberg said. “It’s wonderful that we’re able to move tests out into the community, but we need to know if the community is using them.”

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Even after the COVID pandemic has finally dwindled, RADx will likely stay put.

“Of course, we’d like to leverage all of these RADx investments and processes for other pathogens and preparedness, as we look to the future and expect that there will be more pandemics,” Tromberg said.

The FDA, too, is fully on board. Tim Stenzel, M.D., Ph.D., director of the agency’s office of in vitro diagnostics, said during the panel that after witnessing firsthand the success of the RADx initiative, the FDA is now counting on maintaining its proven success in fostering rapid innovation to meet clinical needs.

“Non-COVID applications of these devices that are developed in RADx already and also potential future devices that could be incorporated into a RADx-like program would be really ideal from an FDA perspective,” he said. “There are needs for additional point-of-care devices, additional home testing and home collection opportunities, and so we feel at the FDA that we have just scratched the surface, in many ways, of the potential for this kind of collaborative effort between academia, government, developers and others involved in the healthcare ecosystem to make substantial differences in health.”