July 25, 2021

NIH-funded COVID-19 home test is first to receive over-the-counter authorization from FDA

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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.

The U.S. Food and Drug Administration granted emergency use authorization (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’s COVID-19 home test offers a complete at-home sampling and testing solution. The single-use, Bluetooth-enabled test cartridge and self-collection swab are designed for consumer use in conjunction with a smartphone.Ellume photo

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.

he 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.

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