FDA Grants Emergency Use Authorization for NIH-Funded Over the Counter COVID-19 Home Test

Dec 21, 2020

by ASME.org

Last week, the Food and Drug Administration (FDA) granted emergency use authorization (EUA) for the first time for an at-home COVID-19 test that consumers will be able to buy over the counter. The test was developed with support from the National Institutes of Health’s (NIH’s) Rapid Acceleration of Diagnostics (RADx) Initiative, a program that aims to speed the development, commercialization, and implementation of technologies for COVID-19 testing.
Ellume USA LLC out of Valencia, California is the company that designed the test using a $30 million contract and technical support from the RADx initiative. The test will retail for around $30 and Ellume plans to distribute millions of home tests each month starting in 2021. The design incorporates real-time result sharing capabilities, so that health professionals, employers, and schools can efficiently track COVID-19 test results.
RADx is managed by the National Institute of Biomedical Imaging and Bioengineering (NIBIB) at NIH. ASME has been supportive of the mission of the NIBIB since its inception in 2001. 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.
For more information on ASME’s government relations agenda in the area of bioengineering, please read our “Investing in Bioengineering: Securing America’s Leadership Role in a 21st Century” position statement.

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