NIH-Funded COVID-19 Home Test Is First To Receive Over-The-Counter Authorization From FDA

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What

The U.S. Food and Drug Administration granted emergency use authorization(link is external) (EUA) today for an innovative COVID-19 viral antigen test developed with support from the National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx) Initiative. Ellume USA LLC, Valencia, California, designed the test for use at home without a prescription. This is the first EUA awarded for an at-home COVID test that can be purchased over the counter. Ellume developed the test with 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 NIH.

The test is performed using a mid-turbinate nasal swab designed for comfortable self-sampling. The sample is inserted into a single-use cartridge that returns results in 15 minutes. The at-home test analyzer connects to the user’s smartphone through Bluetooth and pairs with a downloadable app that provides step-by-step instructions and displays results.

Users can share real-time results from the test, selling for approximately $30, with healthcare professionals, employers, and schools for efficient COVID-19 tracking. Ellume plans to scale-up manufacturing to deliver millions of home tests per month in 2021.

Who

Bruce J. Tromberg, Ph.D., director of NIBIB and lead for the RADx Tech program, can comment on COVID-19 testing technology.

About the Rapid Acceleration of Diagnostics (RADxSM) initiative: The RADxSM initiative was launched on April 29, 2020, to speed 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. It leverages the existing NIH Point-of-Care Technology Research Network. The RADx initiative partners with federal agencies, including the Office of the Assistant Secretary of Health, Department of Defense, the Biomedical Advanced Research and Development Authority, and U.S. Food and Drug Administration.

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 life sciences to advance basic research and medical care. NIBIB supports emerging technology research and development within its internal laboratories and through grants, collaborations, and training.

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 conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases.

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