NEW YORK – The National Institutes of Health's Rapid Acceleration of Diagnostics Tech program has announced two new initiatives to promote the development of accessible and innovative at-home and point-of-care COVID-19 tests.
The new programs, which both opened for applications on Tuesday, have up to $300 million total from the American Rescue Plan Act of 2021 available for participants and have two separate but related goals. The first program is aimed at the development of over-the-counter COVID-19 tests that can be used by people with disabilities, namely blindness, low vision, difficulties with fine motor skills, and aging-related disabilities. The tests should be ready for commercialization in one to two years, according to a statement from the NIH.
Meantime, the second initiative focuses on OTC or point-of-care COVID-19 tests with improved performance that minimize the need for serial testing and aren't affected by variants. Commercialization of these tests is expected in two to three years.
Jill Heemskerk, the deputy director of the National Institute of Biomedical Imaging and Bioengineering within the NIH and the co-lead of the RADx Tech program, noted that the idea for the first initiative came from a letter-writing campaign conducted by disability advocacy groups after the Biden administration announced last year that it would distribute free at-home COVID-19 tests to Americans.
The advocates made it clear that people with disabilities can't conduct most at-home tests by themselves as there are not accessibility features in place to do so. "Their point was 'That's great that the government's making free tests available, but people with disabilities can't use these tests independently in their homes,'" she said.
"It hit us like a ton of bricks what an oversight we had made in our rush to get tests out as quickly as possible," Heemskerk said, adding many of the available at-home tests can't be utilized by everyone since most rely on visual readouts, have complicated instructions, and require using droppers or other small tools to perform the test.
This past March, the NIH hosted a listening session with a variety of advocacy groups to gain a better understanding of their concerns. One plan, separate from the one starting this week, is a fast-track initiative to modify existing tests that are already on the market to quickly improve accessibility, she said.
The recently launched accessibility initiative will focus on completely redesigning tests "from the ground up," although those tests will still rely on the same technologies, like lateral flow. Heemskerk noted that a variety of modifications can be made to improve accessibility. For example, many at-home tests have instructions to not touch certain parts of a test, but people with low vision often use touch to interpret the instructions and manipulate the test. One potential change could be making sure every part of a test is touchable with indicators showing where the top and bottom of a device is located to ensure blind people can use it correctly.
The program will rely on designers and engineers who have expertise in accessibility and making sure to work with users who have disabilities to test the prototypes and confirm they're workable and meet their needs.
Chris Danielsen, director of public relations at the National Federation of the Blind (NFB), said that his group was one of the many disappointed by the White House's oversight of disabled people when distributing at-home COVID-19 tests. When the plan was announced, the NFB reached out to the White House and expressed its concerns, with Danielsen noting that while there are resources other than home tests, the free tests offered by the administration were "completely inaccessible" with no consideration for how people with disabilities would use them.
The White House connected NIH with the NFB, who "emphasized that there was an opportunity to innovate" in the home healthcare space and provided feedback in the NIH listening session in March.
The NFB will also be involved with the new RADx program in an advisory role.
Danielsen also noted that there are other ways to potentially make test results clear to blind people without a visual readout, such as by using reagents that produce a sound or temperature change to indicate a result. "I don't know if any of those are really a possibility for a home test, but it's worth considering," he said.
While there are some at-home COVID-19 tests that can be used by the blind without assistance, they are expensive and require a smartphone, Danielsen said, citing Cue Health's test as one that he personally has used independently, since its app is compatible with text-to-speech readers on smartphones that can verbalize instructions for use and results. But not everyone has access to a smartphone or the money to purchase a Cue test, presenting another issue of access, he said.
Changing the testing landscape
The other program being launched by RADx comes from a goal to "change the testing landscape," Heemskerk said. The high speed and volume requirements of past RADx initiatives have favored standard technologies, such as lateral flow for at-home COVID-19 testing, because it's usually easier to quickly move forward with the manufacturing and commercialization processes. However, since testing capacity has stabilized over the course of the pandemic, speed and volume are less of a concern, and RADx can encourage test developers to pivot toward innovation.
While lateral flow tests are quick and relatively easy to operate — at least for the able-bodied — some in the healthcare community are skeptical about their sensitivity. These tests become more reliable for negative results through serial testing, Heemskerk noted, but that requires multiple tests to be performed over a prolonged period of time, undercutting the speed benefits. Through the new program, RADx hopes to accelerate the development of home-based tests that can perform with the accuracy of PCR-based lab tests.
The new program will require participants to change the game in some manner, whether by significantly lowering costs or improving performance. "Ideally, we would like to see completely new technology," Heemskerk said.
The time frame for this initiative is longer than both the other new disability-focused program and earlier RADx rounds, providing an opportunity for companies that couldn't meet the original time frames to participate and scale up their technology. Heemskerk cited handheld PCR devices as one technology that could be eligible under the program if the cost for the test can be made low enough, but RADx is looking for completely novel technology as well, such as breath-based testing.
For both initiatives, the focus is on COVID-19 testing, but Heemskerk said applicability to other diseases would be "nice to have." RADx itself wouldn't be supporting the development of tests for other diseases, but it is encouraging the development of tests that could be easily modified, whether for different diseases or different SARS-CoV-2 variants. Applicability for new COVID-19 variants, in particular, is a "real plus," she said. "If a test can only ever do one thing, it's not going to have the same value as something that's more flexible."
The NFB's Danielsen also emphasized the importance of applicability across diseases. Accessible COVID-19 tests may be the immediate prize, but he'd like to see "whatever comes out of this process … to really migrate into other home tests at the very least, so that blind people have more independent control and privacy with respect to our own healthcare."
Evaluating the proposals submitted under the new program will be a multistep process involving multiple people, Heemskerk said. Once an application is submitted, it will go to a rapid review panel that will determine whether the proposal is viable. For those developers that move forward, consultants with expertise in regulatory affairs, clinical affairs, manufacturing, and more will meet with the developers and put together a recommendation about whether the application should be supported. That recommendation also lays out the potential risks or problems with the proposal, such as the use of a foreign supplier for manufacturing certain components, for example, or performance issues that require reagent modification.
The agency will then make a decision about first-stage funding, which is lower-stakes and uses a milestone-based approach to address the risks brought up by the consultants. In Phase I, companies usually already have a prototype and some data available, Heemskerk said. If the risks are mediated, the company then progresses to Phase II, or the full funding stage, although she noted that RADx doesn't "just give money to the companies and say, 'Good luck to you.'" The program has different teams that validate the tests and confirm the data from the company is accurate and reproducible.
The evaluation process for both new initiatives has evolved somewhat from the original evaluation process conducted by RADx with its first programs in 2020 and 2021, but overall looks very similar, she said. There have been some companies that have received RADx grants to commercialize their tests that have never brought a product to market, and that is something the program has built into its expectations. "One thing we kind of accept in this program is that there is risk in everything, particularly when you're developing a new technology," she said.
Sometimes a company can't go any further in the commercialization process, and in that case RADx will take back the money a firm hasn't spent on the contract, but it won't get the money back that has already been invested — the process it has followed for every project. "That's just a sunk cost, because if you only invest in things that are sure bets, you're going to keep churning through the same technologies over and over again," according to Heemskerk.
Startups tend to be the companies that struggle under RADx's requirements, she added. "Although there's a lot of innovation coming there, it tends to be more difficult … to turn a design into a marketed product" at a startup, often because there's "not enough business structure." For example, building new manufacturing lines for a startup is more expensive and time-consuming than relying on a company with an established manufacturing facility.
That's not to say that no startups have been funded or will be funded, however. Particularly for the second program focused on innovation, the longer timeline may provide additional opportunities for smaller companies to get involved.
"The main thing is to let the manufacturers take the time to innovate that they haven't had in the past," Heemskerk said.