RADx reloaded: NIH puts out the call for more effective, easier-to-use COVID tests

In the two-and-a-half years of the COVID-19 pandemic, diagnostic test makers have fine-tuned their development and manufacturing processes to quickly roll out countless tests for the virus, many of them helped along by infusions of federal funding specifically set aside for innovative new testing approaches.

And the government isn’t done yet. With its sights set on the endemic stage of the coronavirus, the National Institutes of Health has re-upped its call for new and improved COVID diagnostics, it announced Thursday.

The summons arrives via the Rapid Acceleration of Diagnostics Tech program, or RADx, which launched in the early days of the pandemic with an initial commitment of $1.5 billion and a “Shark Tank”-style competition to quickly develop both at-home and point-of-care tests for the virus.

RADx is managed by the NIH's National Institute of Biomedical Imaging and Bioengineering, with additional support from other government agencies such as the FDA, CDC and the Biomedical Advanced Research and Development Authority (BARDA). Since the start of the pandemic, it’s had a hand in developing at least four dozen COVID testing technologies.

This time around, RADx is offering a total of $300 million in funding from the 2021 American Rescue Plan Act. The funds will help support not only the development of the new tests but also their regulatory aspirations—including both pandemic-induced emergency use authorization and full market clearance.

The program is specifically seeking diagnostics that fall into two categories, both aimed at improving accessibility and usability. The first category is aimed at people with blindness, low vision, fine motor skill difficulties, aging-related disabilities and other conditions that may make certain tests challenging to use. The NIH is looking for over-the-counter tests that’ll be easier to use and that can be ready for commercialization within one to two years.

The other category of tests will combine updated designs that make them simpler to use and improved diagnostic technology that eliminates the need for repeated testing and variant-specific adjustments. Proposals in this category can include both over-the-counter and point-of-care tests and should be ready for commercialization within two to three years.

The NIH will begin accepting applications for this new phase of the RADx program Sept. 20.

The NIH’s revamped call for COVID tests comes as another area of the executive branch re-ups its own efforts to make diagnostics more accessible across the country.

On Thursday, the Biden Administration outlined a plan to purchase another 100 million at-home rapid tests from U.S.-based manufacturers. Though it noted that the buy won’t fully replenish the national stockpile of at-home diagnostics, “this procurement will help meet some testing needs in the months ahead and will put us in a better position to manage a potential increase in testing demand this fall and winter.”

The White House’s announcement comes a week after it paused the distribution of free test kits through the COVIDTests.gov website, citing Congress’ repeated denials of its requests for more COVID-focused funding.