He NIH Rapid Acceleration of Diagnostics (RADx) Initiative announced today that it has awarded contracts totaling $77.7 million to develop and manufacture 12 new rapid diagnostic tests for SARS-CoV-2, the virus that causes COVID-19. Home and point-of-care testing platforms address the need for high-throughput, low-cost home and point-of-care tests that can potentially detect multiple respiratory infections. These projects are part of the RADx technology programwhich involves an intensive evaluation of the feasibility of the concept, similar to a “shark tank”, carried out by a panel of technical, regulatory and commercial experts. The awards support development, validation, scale-up and manufacturing with the goal of bringing the necessary tests to market starting this year.
“These technologies represent important innovations to address the need for easy access to rapid, low-cost testing across the country, including in every home,” said Bruce J. Tromberg, Ph.D., director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) and leader of RADx Tech. “The ability to perform simultaneous testing for multiple types of infection at the point of care is a new frontier we hope to advance and could be an important step toward transforming healthcare in the United States.” United.”
The new grants are in addition to 33 that the NIH previously disbursed through its technology development program. The RADx Tech program has resulted in 32 emergency use authorizations (EUAs) from the US Food and Drug Administration, including support for the first home testing EUA. Companies supported by the RADx program that achieved an EUA have contributed more than 840 million tests to the US market since fall 2020.
The new tests that receive support for development, validation, manufacturing and scale-up are:
Viral RNA detection
Detect, Guilford, Connecticut
A rapid reverse transcriptase loop-mediated isothermal amplification platform (RT-LAMP) with mobile app-guided instructions to detect SARS-CoV-2 in approximately 60 minutes. The test is anticipated to have analytical performance nearly as high as laboratory-based polymerase chain reaction (PCR) tests, but in a compact, cost-effective package designed for point-of-care settings and home use. The technology can also be expanded to detect other respiratory pathogens such as influenza A/B.
Palogen, Palo Alto, California
A nanoelectronic biosensor that detects SARS-CoV-2 RNA in three minutes. The technology is initially intended for use at the point of care.
Quidel, San Diego
A real-time PCR platform that simultaneously detects influenza A/B, respiratory syncytial virus and SARS-CoV-2 in less than 25 minutes. The platform has the ability to expand to a multiplex of 12 assays at a time. The test is expected to be highly accurate and sensitive and will be intended for use in point-of-care settings such as small hospitals and urgent care clinics.
Uh-Oh Laboratories, Santa Clara, California
A portable, reusable RT-LAMP device with single-use cartridges that detects SARS-CoV-2 within 30 minutes. The cartridge can be expanded to detect other respiratory pathogens such as influenza A/B. The test is designed for use in point-of-care settings and is suitable for use in K-12 schools, universities, healthcare facilities, and businesses. The test will also be validated for home use.
University of California, Los Angeles
A next-generation sequencing technology for COVID-19 testing that will be expanded to help increase surveillance of cases and variants in the United States. The technology allows samples to be combined and processed in a larger batch to reduce cost and processing time without compromising accuracy. The test is designed for use in a highly complex laboratory.
Viral antigen detection
Becton, Dickinson and Company (BD), Franklin Lakes, New Jersey
Two independent product lines to detect SARS-CoV-2 in 15 minutes or less. One is a lateral flow immunoassay with a reader that provides electronic results intended for use in point-of-care settings. The second is an at-home lateral flow test that is read digitally using a smartphone.
Ellume USA LLC, Frederick, Maryland
A single-use digital fluorescent immunoassay antigen test for SARS-CoV-2 and influenza A/B all-in-one platform. Results are obtained in 15 minutes or less. The platform is paired with a mobile app for ease of use and is designed for use in point-of-care environments.
Luminostics, Inc. (dba Clip Health), Milpitas, California
A rapid, smartphone-connected antigen immunoassay that uses glow-in-the-dark nanomaterials to detect and differentiate SARS-CoV-2 and influenza A/B. A reusable reader delivers results in 15 minutes and the test is designed for use in point-of-care settings.
LumiraDx, Waltham, Massachusetts
A microfluidic immunofluorescence assay that can detect SARS-CoV-2 and influenza A/B is expected to have a sensitivity close to laboratory PCR. Multiplex assay results are provided in less than 15 minutes. The test is designed for use in point-of-care settings.
Princeton BioMeditech, Monmouth Junction, New Jersey
A lateral flow assay antigen test that simultaneously detects and differentiates between SARS-CoV-2 and influenza A/B all-in-one test. The test provides visibly read results in approximately 15 minutes. The test currently has EUA for use in moderate and high complexity point-of-care and laboratory settings. The test will be validated for use at home.
Quidel, San Diego
Two lateral flow assays are combined in a single package to detect SARS-CoV-2 and influenza A/B viruses. Results are visible on the test strips in less than 15 minutes. The combined test is being developed for use in point-of-care settings.
About Rapid Acceleration of Diagnostics (RADx)YE) initiative: The RADx initiative was launched on April 29, 2020 to accelerate innovation in the development, commercialization and deployment of technologies for COVID-19 testing. The initiative has four programs: RADx Tech, RADx Advanced Technology Platforms, RADx Underserved Populations and RADx Radical. Leverages existing NIH point-of-care technology research network. The RADx initiative partners with federal agencies, including the Office of the Assistant Secretary for Health, the Department of Defense, the Biomedical Advanced Research and Development Authority, and the U.S. Food and Drug Administration. Learn more about the RADx initiative and its programs: https://www.nih.gov/radx.
About the National Institute of Biomedical Imaging and Bioengineering (NIBIB): NIBIB’s mission is to improve health by leading the development and accelerating the application of biomedical technologies. The Institute is committed to integrating the physical and engineering sciences with the biological sciences to advance basic research and healthcare. NIBIB supports research and development of emerging technologies within its internal laboratories and through grants, collaborations and training. More information is available on the NIBIB website: https://www.nibib.nih.gov.
About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 institutes and centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency that conducts and supports basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures of common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
NIH…Turning Discovery into Health®
###
