The US Food and Drug Administration (FDA) granted emergency use authorization (EUA) on December 15 for an innovative COVID-19 viral antigen test developed with support from the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) Initiative.
Ellume USA LLC, of 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.