NIH has awarded another round of contracts for the development and expanded manufacturing of new COVID-19 diagnostic testing technologies. The four new contracts, administered by the NIH Rapid Acceleration of Diagnostic Technology (RADx) Initiativetotal $29.3 million and will help increase point-of-care and laboratory testing capacity for COVID-19 surveillance in schools, businesses, and communities.
Since its inception almost a year ago, RADx Tech, a branch of the RADx initiative, has aimed to support a diverse portfolio of products that address the evolving needs of the pandemic. At the beginning of the pandemic, laboratory technologies for COVID-19 testing were leveraged, adapted, and expanded to rapidly increase U.S. testing capacity. At the same time, portable devices and mobile laboratories were also supported to make testing more accessible in hot spots and rural communities across the country at the point of care. Now, low-cost rapid antigen tests are beginning to bring testing to American homes to increase the frequency and ease of testing.
To date, the U.S. Food and Drug Administration (FDA) has issued 16 emergency use authorizations (EUAs) for COVID-19 diagnostic tests supported by RADx, including the first EUA for a fully at-home COVID-19 test developed by Ellume Health.
By the end of March 2021, the RADx program is expected to deliver two million COVID-19 tests and diagnostic supplies to the U.S. per day. Ellume has produced more than 300,000 of those tests to begin bringing them into homes.
“RADx de-risked and clinically validated its first at-home COVID-19 test (Ellume), making possible the February 2021 acquisition of 8.5 million additional tests by the U.S. Department of Defense,” said Bruce J. Tromberg, Ph.D., director of the National Institute of Biomedical Imaging and Bioengineering and leader of RADx Tech, one of four programs in the NIH RADx initiative. Ellume is expected to continue to simultaneously ramp up production to more than 100,000 tests per day for the RADx program while building manufacturing facilities in the US.
“As the coronavirus continues to evolve, we must continue to support diagnostic device developers as they advance and adapt technologies to meet the needs of the pandemic,” said Dr. Tromberg.
RADx Tech’s new contracts include tests that address a variety of gaps in the current COVID-19 testing landscape. New variants of the virus are emerging across the United States, and it is becoming increasingly clear that some therapies and vaccines may show reduced effectiveness against certain variants. “We need tests that are able to detect and identify variants. This is crucial to track the prevalence of variants and monitor any impact on treatments and vaccines,” adds Dr. Tromberg.
As public health officials allow visitors to return to shared public spaces like sports stadiums and concert halls, rapid testing will help curb transmission of the virus. Tests that support batch pooling of samples can increase the number of samples tested per day, while reducing the costs and materials required for testing.
Since its launch in April 2020, the RADx program has provided technical expertise for product development and validation, regulatory guidance to help projects meet criteria for FDA clearances, and financial support to help companies scale up manufacturing of COVID-19 tests. Currently, 29 projects have advanced through multiple review phases to increase US COVID-19 testing capacity by more than 180 million tests.
The following companies have achieved key RADx Tech milestones and will receive manufacturing and scale-up support:
Point-of-care testing
GenBody Inc., Cheonan, South Korea
A unique, visually readable, lateral flow rapid testing system capable of detecting SARS-CoV-2 and can deliver results in 20 minutes. The test uses nasopharyngeal swabs or nasal swabs and can be performed by a healthcare professional at the point of care. A home test is being developed for future use.
Xtrava Inc, dba Xtrava Health, Santa Clara, California
A lateral flow immunoassay platform technology suitable for the detection of SARS-CoV-2 antigens from shallow nasal samples. In the presence of the virus, a visible line develops in 15 minutes or less. The technology can be used in professional point-of-care settings, such as drive-thru testing clinics, doctors’ offices or nursing homes, as well as for health monitoring by trained staff in shared public spaces, such as a sports stadium or concert hall. A handheld digital reader is currently being developed for increased sensitivity and an accompanying smartphone app for use of this technology without a prescription.
Laboratory tests
PathogenDx, Scottsdale, Arizona
A low-cost, high-throughput test that targets multiple genetic sites on the SARS-CoV-2 virus with high precision, thus aiming to detect and identify SARS-CoV-2 variants. The results are delivered in five hours. The test also has the ability to pool up to six saliva samples for surveillance testing in schools, businesses and communities, performed manually or on automated platforms in small and medium-sized laboratories. Currently, 96 samples can be tested at a time and the test is compatible with saliva, nasopharyngeal swab and oral samples.
Meridian Biosciences, Cincinnati, Ohio
A single-use, automated, microfluidic cartridge-based RT-PCR test for the detection of SARS-CoV-2 from nasopharyngeal swabs. Provides rapid results available in approximately 45 minutes, which is comparable to the turnaround times of point-of-care antigen testing. The test is designed for use by qualified laboratory personnel and regulatory approval will be sought for use in high and moderate complexity laboratories. Additionally, a respiratory panel is being developed that includes SARS-CoV-2, influenza A/B, and RSV in a single test.
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.
