NEW YORK – Fulfilling the claim in its name, the Rapid Acceleration of Diagnostics (RADx) Tech program propelled production of COVID-19 tests in the US during the pandemic.
Now firmly in the post-pandemic era, the program has pivoted to support other healthcare segments with diagnostic testing gaps, and has also begun to recapitulate its novel hybrid funding and support approach throughout the National Institutes of Health.
The RADx Tech program spurred the development and manufacture of approximately 7.8 billion COVID-19 tests between September 2020 and April 2023, with a peak production of more than 2,000 tests each second in June 2021. With COVID-19 now a much-diminished threat, however, representatives of RADx, a program housed in the NIH's National Institute of Biomedical Imaging and Bioengineering, have recently laid out how the program is transitioning and disclosed some of its long-term goals.
RADx Tech's novel approaches — from its "shark tank" innovation funnel and rapid application review, to its intensely collaborative, milestone-driven funding process — differ starkly from traditional and much larger federal programs supporting diagnostics development, such as the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs.
"This is not your father's NIH," Taylor Gilliland, senior adviser for innovation programs within the office of the director at NIBIB, said in a presentation last month at the Precision Medicine Tri-Conference in San Diego.
Indeed, the RADx Tech program was able to move developers with novel technologies through what is typically a multiyear process of development, validation, regulatory authorization, and manufacturing scale-up within a compressed timeline of six to 12 months, Gilliland said in a follow-up interview. It also spun off an Independent Test Assessment Program (ITAP), a program called Mobile At Home Reporting Through Standards (MARS), and an accessible test initiative. And, while the SBIR program is roughly 4 percent of the overall NIH budget, RADx Tech is a smaller part of NIH's broader entrepreneurial support ecosystem but is "much more targeted and a little more focused on specific technology areas and specific disease conditions," Gilliland said.
But the program has also evolved and changed over time, he said, and now aims to address many different conditions beyond respiratory diseases with devices beyond in vitro diagnostics. It also plans to "evolve into a broader medical technology accelerator platform that we're hoping our colleagues across NIH can tap into and leverage," Gilliland said.
These goals will need to be accomplished with an admittedly smaller budget, however. While it previously had a final budget of approximately $1.7 billion in congressional appropriations to address the pandemic, each individual RADx program will now have its own budget based on available funding, Gilliland said.
Currently, there are three ongoing COVID-19 projects with a ballpark figure of $100 million in support, he said, which comes from the remainder of the pandemic allocation. These include the accessible test program, a high-performance test development program, and a multiplex respiratory panel evaluation program at ITAP.
But, Gilliland noted at Tri-Con, "the best way that we can show value of continued investment of the taxpayer funds into these programs is to continue to pivot and adapt."
To that end, the RADx Tech program has also created several new programs, he said in an interview, using additional funding. For example, its maternal health and fetal monitoring challenges are supported by $12 million and $2.5 million, respectively, from the Point-of-Care Technology Research Network (POCTRN) and other partner institutes at the NIH.
Other programs in the newly expanded RADx Tech efforts support diagnostics development for hepatitis C elimination, HIV viral load testing at the point of care, and mpox diagnostic lesion panel development and are supported through collaboration with POCTRN and other NIH programs to the tune of a few million dollars each.
Metrics and proliferation
As previously described by Bruce Tromberg, director of the NIBIB, the main measure of success for the original RADx Tech program is the now more than 8 billion COVID-19 tests it helped make available on the market. Beyond the increased testing capacity for the country, the program also helped normalize and explain over-the-counter infectious disease testing to the public.
In total, RADx Tech supported companies through 55 Emergency Use Authorizations from the US Food and Drug Administration, 18 of which were over-the-counter EUAs, and helped three multiplex tests reach the market through the ITAP program. It accomplished this by providing "wraparound support," Gilliland said, through four verticals of technology development, regulatory, clinical, and commercialization.
Another success story is the Home Test to Treat program, which launched in January last year. The program has now gone nationwide, Gilliland said, and is currently focused on helping underinsured and uninsured people obtain free multiplex home COVID and flu testing, with free telehealth appointments for people who test positive and free antiviral medication shipped to them, if needed.
"This is really a demonstration project that's met or exceeded many of its goals," Gilliland said in his Tri-Con presentation. The program enrolled almost 60,000 people into clinical studies, delivered over 8,000 telehealth visits, and administered more than 6,500 antiviral prescriptions. The team also developed a website to allow people to report their own at-home COVID-19 rapid test results.
However, beyond the pandemic, bringing another 8 billion diagnostics for other ailments to the market is hopefully not going to be necessary again anytime soon, so the program expects to use other metrics of success besides production numbers. While it is admittedly harder to measure, Gilliland said in an interview that the team is gathering data to capture the value that companies and academic investigators get from the program and the ways participation has accelerated their timeline to market entry.
Testimonials from the innovators RADx Tech supports suggest the process is instrumental for commercialization, he said, noting that many of these companies are academic spinouts, startups, and small- or medium-sized companies that may not have taken a product all the way through to marketing.
"They really appreciate the fact that through RADx they can get access to consultants in these fields, key opinion leaders in the clinical areas that they are working in, and with the ITAP program, be plugged into that close collaboration with FDA, ensuring standardized clinical testing protocols, reporting protocols, and multiple steps of obtaining regulatory approval," Gilliland said. "They're finding that to be tremendously helpful and really shortening their development timelines, and that's our goal."
Without the $1.7 billion, the RADx team is also adapting and scaling appropriately.
For example, the HIV viral load program has a budget of $2 million, according to Shawn Mulvaney, a program officer at RADx. The scaled down endpoint goal with such a budget is to de-risk the products rather than bring them all the way to market, he said in a presentation at Tri-Con.
For the HIV program, 18 applications were honed to five, which then began the process with a market and landscape analysis. Replacing the larger-scale COVID-19 test development support, RADx organized a regulatory seminar that allowed the companies to have very specific questions asked and answered, Mulvaney said, and each team was given 10 hours of one-on-one with key opinion leaders and subject matter experts in regulatory, marketing, and manufacturing. In addition, the program funded a sample repository at a proctoring center within Northwestern University, he said.
At a panel discussion at Tri-Con last month, Rainer Ng, head of tech development at Baebies, said his firm is developing a system called Finder that can perform molecular, immunoassay, enzymatic, and coagulation testing in a single cartridge using digital microfluidics and moving droplets about with electricity. For the HIV viral load testing, Finder enables on-cartridge plasma separation from whole-blood samples and can perform sample-to-answer PCR testing in 15 minutes. In his presentation, Ng said contrived experiments using blood from healthy individuals spiked with different clades of HIV showed the system could detect all of them at 1,000 copies per ml in 64 out of 67 samples.
To Ng, the most important aspect of the program is the "through line to FDA," he said during the panel discussion, adding, "I really think that with all government-commercial partnerships in the future, it should really be the standard." The current system, in contrast, leaves developers unsure of what the FDA is looking for until they are ready to submit an application, which Ng said is akin to meeting with an academic adviser for the first time two months before graduating from college.
Stuart Ray, a professor of infectious diseases at Johns Hopkins guiding the Baebies team, said at Tri-Con that they meet every two weeks to help articulate milestones that can be measured and successfully achieved. "It's a dance, and I think it is the healthy thing to have somebody outside your own brain pushing you to do the things that you need," he said.
However, Ray also said that one of the biggest impediments in development of diagnostic tests generally is "paving the regulatory path ahead of people [and] develop[ing] a set of thresholds that they need to meet, that the FDA will accept as sufficient for a particular purpose." That facet is especially difficult with innovative technologies, he said, as the metrics and use cases often differ from predicate devices. "I think that more intention around paving the regulatory path is a key part of innovation that we could do better with as a whole."
RADx is also seeking to proliferate its model.
"We're hoping to become the technology accelerator for medical devices for all of NIH, and even for all of the US government," Gilliland said. "That is our value proposition, and we're trying to get our other NIH institutes and centers and other federal agencies to leverage our resources, our platform, and our infrastructure to deliver on their technology needs."
To execute this, RADx continues to communicate with other groups at NIH on how the program works, what its successes have been in the past, and how it is evolving, Gilliland said. The overall aim is to structure partnerships that can "achieve the technology goals of fellow institutes and centers as well as other government agencies partnering with nonprofit entities."
"We're really hoping that this incredible infrastructure and process and approach that we build for COVID can be sustained to address the medical technology needs, diagnostics, wearables, and remote monitoring technologies for many other diseases and conditions to address the healthcare of this nation," he said.
As part of this expanded, collaborative effort, the RADx Tech program has become the MedTech development arm of a trans-NIH neuroscience Blueprint MedTech program. The overarching Blueprint Neuroscience program has been around since 2004, Gilliland said, and the MedTech arm, which launched in 2022, utilizes the infrastructure and processes of the RADx Tech approach to accelerate device development for neurological disorders and conditions.
By and large, participants in the RADx Tech program have been exuberant about the opportunities for collaborative acceleration of their technologies.
Future directions
Gilliland said RADx Tech now aims to ferry more companies across the "valley of death" between product development and marketing a regulated medical product.
With the maternal health and fetal monitoring programs, which Gilliland is spearheading, there are "massive needs for improvement in risk assessment, monitoring, and diagnosis, and some of which relate to neglected healthcare issues."
For example, the March of Dimes estimates that 2.2 million women of childbearing age live in maternal healthcare deserts, and 150,000 births each year take place in these areas with low or limited access to appropriate maternal care.
RADx is collaborating with the National Institute of Child Health and Human Development and the Office of Research on Women's Health to launch RADx Tech for Maternal Health, one of its first post-COVID, post-infectious disease pivots, Gilliland said at Tri-Con. The program aims to address the greatest causes of postpartum morbidity and mortality, including cardiovascular disease, cardiomyopathy, hemorrhage, sepsis, and postpartum depression. And, it is not limited to IVD testing, but also open to things like wearables, smartphone enabled tools, and integrated sensor technologies.
The program is utilizing the innovation funnel model and pivoted to a "no strings attached cash prize" funding process, Gilliland said, instead of a grant or contract, whereby companies received non-dilutive cash from the US government for meeting milestones.
In fetal monitoring, the Phase 2 winners include Bloomlife, NextGen, Raydiant Oximetry, Softsonics, Storx Technologies, and the Mayo Clinic. Now in the Phase 3 tech development "sprint" portion of the six-to-nine month rolling funding process, these teams are currently getting full wraparound support to mitigate the risks across technology, clinical, regulatory, and commercialization, Gilliland said.
For maternal health, a cohort of 10 companies is in the tech assessment milestone phase, with products in clinical studies at a few US university health systems. These include a mobile app that assesses anemia by capturing fingernail images, wearable cardiovascular monitors, epigenetic tests to assess risk for postpartum depression, and point-of-care devices to assess hemorrhage risk. A wearable device from CardieX monitors and identifies the potential risk for developing cardiovascular conditions associated with pregnancy, such as preeclampsia. RADx expects to announce winners of the Maternal Health Challenge in the fall.
RADx continues to develop standardized, centralized protocols with the FDA through the ITAP program and aims "to be a trusted third-party provider of clinical validation and test performance," Gilliland said. It is also working with partners at the FDA to explore building on ITAP and expanding it beyond IVD and COVID, he said, for example, with the mpox lesion panel evaluations that led to a point-of-care EUA and a pending home-collection test kit.
It will also continue to evaluate new areas where it might make an impact, focusing on gaps in diagnosis and monitoring coupled with insufficient private investment to drive technology development. "That's the real niche where we can really have substantial success," Gilliland said.
Possible next steps might include sexually transmitted infection testing using a telehealth model and supporting the broader women's health initiatives of the current administration with innovative MedTech. Although these are only potential programs, they are examples of "areas that are ripe for the innovation that RADx can deliver," he said. With STIs, RADx has already shown with COVID testing that it can develop the IT background enabling data transfer to automatically plug results into state and national public health data systems.
"The role of government is to come in and address gaps in public health delivery," Gilliland said.
In cases where the needed medical technology isn't currently available on the market, "we're confident that programs like RADx can help fill in those gaps," he said.