Transcript of discussion between NIH’s Dr. Bruce Tromberg and Dr. Frances Collins on NIH efforts to develop rapid COVID-19 test using a “RADx” a venture capitalist “shark tank” strategy to discover and fund in bold ideas with hopes of commercial tests on market by September.
In the United States, where there are approximately 400,000 to 900,000 novel COVID-19 tests per day, most testing is still being done in laboratories or complex facilities, where it takes a while for those tests to be processed and for people to get results. The National Institute of Health's Dr. Frances Collins and Dr. Bruce Tromberg come together to discuss the latest progress of new technologies for SARS-CoV-2 diagnostic testing in the United States, and their investment in creating more convenient at home or point-of-care tests. Tromberg, aided by financial assistance from Congress’ funding to the NIH, created the Rapid Acceleration of Diagnostics Initiative (Radx) to bolster the country’s diagnostic testing capacity within months and make it possible that everyone has access to diagnostic testing for COVID-19 as easily and quickly as possible.
Tromberg is focused on finding the best technologies and scaling them up quickly, so they can be used across the nation to optimize the management of COVID-19. He is particularly focused on lateral flow assay technologies, as these tests are small enough to fit in your hand and come in a convenient container. How the technology works is: you would take a swab from your oral cavity and place it on one of the pads, add a little bit of solution, then the actual assay itself has a membrane inside of a little plastic container and when the fluid flows across the membrane, it can detect genetic material from the coronavirus. Swiftly, a line will “light up” to tell if there is the presence of a virus inside the swab.
Another palm-sized convenient type of lateral flow assay can look for proteins on the surface of the virus, meaning you don’t have to break up the virus particle itself, but an aptamer would capture the virus in this membrane. An aptamer is similar to an antibody, except it’s made from nucleic acid and is designed to bind very tightly with any molecule of interest. If you put a saliva sample into this assay, it moves up the membrane where some chemistry takes place, and then, you would see a line appear given the presence of a virus. NIH labs are still learning if saliva tests are a viable option. Of the RADx-tech, there are at least nine companies that are in what “phase one,” moving towards commercialization and of those companies, more than half are looking at saliva or other kinds of sampling versus current taking swabs in the nasal cavity.
Another type of at home lateral flow assay test is one that fits directly into a mobile device like a tablet. It has a separate lateral flow apparatus, which looks like an elongated zip drive, and it slides right into the tablet itself. The presence of the virus would be indicated by a color of light reaction coming directly from the lateral flow strip.
On last example is a nucleic acid test, a rectangular hand-held device that looks inside the virus to amplify small traces of its nucleic acid to detectable levels. It is completely self-contained. Currently, you can only find these in complex laboratories, but efforts are being made to shrink their size and complexity to be on the market as a point-of-care test without losing its performance quality.
Because of Radx’s innovation funnel “shark tank,” Tromberg believes that there will be commercialized lateral flow assay tests at least by next fall that will make testing accessible, accurate, inexpensive and quick.
NIH and NIBIB’s Point of Care Technology Research Network (POCTRN) is focusing almost exclusively on COVID testing. With five sites and over 200 employees in the US, POCTRN has core resources, personnel, and expertise that are contributing to RADx-tech. If anyone has an idea about a COVID-19 test, you can apply for funding on the POCTRN website and your application will be reviewed by a panel of 30 experts within a day, if approved, it will move to the next stage, which is the shark tank. In the shark tank (also referred to as “phase zero”), a team of experts spends about 150 to 200 person-hours with you evaluating the strengths and weaknesses of your test technically, clinically, and commercially. From this careful analysis, a detailed proposal is presented to a steering committee, then sent to NIH. If accepted, the project will enter phase one, with considerable financial support and the expectation that the company will hit its validation milestones within a month.
Since Radx began on April 29, 2020, almost 60 projects have emerged from this shark-tank. Tromberg believes there will be around 15 projects in the phase one stage in July 2020 alone. If projects reach their validation milestones in the first month, they will be eligible to move to phase two, which involves much more money, so companies can begin to manufacture and scale up for distribution.
Tromberg’s goal is to have between five and 10 companies emerge over time from this innovation funnel, with at least two products coming out this summer. Part of this will come from Radx-tech “shark tank,” but also from NIH’s initiative called Advanced Technology Platforms (RADx-ATP), which is designed to scale up existing technologies. RADx-ATP focuses on companies who already have the expertise and funding, but need additional support, so NIH supplies help with regulatory issues, commercialization, and manufacturing.
Another facet of the program is the component for doing demonstration projects, called RADx-UP, where NIH provides cutting-edge testing technologies in underserved populations. Given the resources from Congress, it is a very high priority of NIH to bring together technology development while addressing health disparities, by bringing these technologies to communities that would benefit significantly from them.
Finally, RADx-rad is the initiative for the futuristic technologies that will not be ready during the time pressure of the innovation funnel. Typically generated from NIH institutes and center, these are fantastic and non-traditional ideas and projects that need to be supported with a longer time-window of return.
The NIH’s focus is on COVID-19 and the need for testing, hoping to have a vaccine ready by the end of 2020 or the early part of 2021. Tromberg’s goal is the capacity to test roughly 2 percent of the population, around 6 million people per day, and would like to see testing technologies move away from being based predominantly in laboratories to accessible at home technologies.