The National Institutes of Health has awarded three new contracts totaling $36.7 million for the development of new COVID-19 diagnostic testing technologies and the production of swabs and sample collection kits. He Rapid Acceleration of Diagnostics (RADx) Initiative has made progress in expanding 25 testing projects since July 2020, now including lab-based, point-of-care and potentially at-home formats.
Over a 15-week span earlier this year, the RADx Tech program solicited and received more than 700 proposals from diagnostic device developers at universities and companies (from startups to large enterprises) proposing new diagnostic technology concepts to address the urgent need for COVID-19 testing. The program qualified 137 of the proposed ideas for entry into in-depth evaluation, of which 47 emerged for further development and validation. The newly awarded projects now move on to the next phase of expansion and commercialization.
“The NIH RADx initiative has sparked innovation and produced an impressive array of COVID-19 testing platforms, from labs to point-of-care, and at-home testing will soon follow,” said Bruce Tromberg, Ph.D., director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) and leader of RADx Tech, one of four components of the NIH RADx initiative. “Along with sophisticated diagnostic tools, we have also turned to products that address supply shortages, continuing our support to accelerate and scale up public health efforts to contain the virus and return the nation to normal activities.”
This announcement includes point-of-care testing technologies as well as the possibility of at-home test administration. Additionally, RADx Tech announced support for technologies that will improve sample collection, an integral aspect of the diagnostic testing process.
New sample collection methods to overcome swab shortages
Shortages of essential supplies, from personal protective equipment for health care workers and ventilators for patients, have compounded the already difficult logistics of responding to the COVID-19 pandemic in the United States. With demand for diagnostic testing increasing, supply shortfalls in swabs and sample collection kits have also posed problems. RADx’s support of alternatives to standard swabs will help meet high demand and alleviate supply bottlenecks.
Oasis Diagnostics Corporation, Vancouver, Washington
Unique saliva and cheek swab collection kits used with multiple types of testing platforms, such as RT-PCR, antigen, and next-generation sequencing. The collection kits purify saliva samples, mitigating various problems related to viscosity and impurities. The collection kit can be used for at-home, self-collection, or point-of-need collection as samples remain stable at room temperature.
Yukon Medical, Durham, North Carolina
Three types of swabs—for nasal, middle turbinate and nasopharyngeal specimens: They are designed for optimal specimen collection and maximum release and can be used with multiple test methods. The swabs also have a breakpoint that can be customized to the specific diagnostic test to reduce the risk of sample contamination. Nasopharyngeal swabs require administration by a healthcare professional, middle turbinate swab requires clinical observation, and nasal swabs allow for at-home collection.
New rapid point-of-care antigen tests with possible at-home testing formats
ANP Technologies, Newark, Delaware
A lateral flow immunoassay platform technology that detects SARS-CoV-2 antigens in nasal samples. The rapid antigen test provides results in 15 minutes at the point of care and is being validated for possible use at home.
Quidel, San Diego
RADx Advanced Technology Platforms (RADx-ATP) expanded its previous contract with Quidel to now include the QuickVue SARS antigen test, for which the U.S. Food and Drug Administration granted emergency use authorization on December 18, 2020, for use in point-of-care settings. (The original contract announced last summer was for Quidel’s Sofia SARS Antigen FIA test kit.)
The QuickVue test uses a dipstick (a paper-like test strip that is dipped into a sample tube) to detect SARS-CoV-2 antigens in nasal swabs. Results are displayed in 10 minutes without a specialized e-reader. It will be offered at a competitive price and in quantities that allow for wide distribution in the United States. The test is undergoing further validation for possible at-home use.
The NIH RADx initiative is comprised of four programs that address the challenges of the COVID-19 pandemic and the corresponding responses of the scientific community. RADx Tech and the RADx Advanced Technology Program leverage the Point-of-Care Technology Research Network (POCTRN), managed by NIBIB and spanning multiple leading universities, to manage, evaluate and validate technologies. Additionally, the RADx initiative’s partnerships with federal agencies, including the Biomedical Advanced Research and Development Authority, the Office of the Under Secretary for Health, the Department of Defense, and the FDA, are critical to the success of the RADx initiative.
