That:
The US Food and Drug Administration granted emergency use authorization (US) today for an innovative COVID-19 viral antigen test developed with support from the National Institutes of Health Rapid acceleration of diagnosis (RADx) Initiative. Ellume USA LLC, Valencia, California, designed the test for use at home without a prescription. This is the first EUA granted for a home COVID test that can be purchased without a prescription. Ellume developed the test under a $30 million contract and technical support from the RADx Tech program, managed by the National Institute of Biomedical Imaging and Bioengineering (NIBIB), part of the NIH.
The test is performed using a mid-turbinate nasal swab designed for convenient self-sampling. The sample is inserted into a single-use cartridge that returns results within 15 minutes. The home test analyzer connects to the user’s smartphone via Bluetooth and pairs with a downloadable app that provides step-by-step instructions and displays results.
Users can share test results in real time.—I sell for approximately $30—with health professionals, employers and schools for efficient tracking of COVID-19. Ellume plans to expand manufacturing to perform millions of at-home tests per month in 2021.
WHO:
Bruce J. Tromberg, Ph.D., NIBIB director and RADx Tech program leader, can comment on the COVID-19 testing technology.
Contact:
To schedule interviews, contact the NIBIB Press Office, (301) 496-3500, nibibpress@mail.nih.gov.
About Rapid Acceleration of Diagnostics (RADx)YE) initiative: The RADxYE The initiative was launched on April 29, 2020 to accelerate innovation in the development, commercialization and implementation 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.
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