Officials announced Monday that the departments of Defense and Homeland Security have struck a deal to bring the U.S. its first over-the-counter, at-home COVID-19 test kits.
The kit, manufactured by Ellume USA LLC, will be the first at-home test available in the U.S. Officials with the U.S. Food and Drug Administration previously authorized emergency use of the kits in December.
In a news release, officials said the deal, worth $231 million, “will allow Ellume USA LLC to increase production capacity of the Ellume COVID-19 Home Test Kit in the United State by 640,000 tests per day by December 2021, to support domestic COVID-19 testing.” As part of the expansion process, officials said they will procure 8.5 million tests to be distributed across the U.S.
“These are over-the-counter, self-performed test kits that can detect COVID with roughly 95% accuracy within 15 minutes,” White House coronavirus adviser Andy Slavitt announced at a news briefing Monday. “They can be used if you feel symptoms of COVID-19 and also for screening for people without symptoms so they can safely go to work, to school and to events. They are appropriate for people ages 2 and over.”
Officials with Ellume announced in December that the company had received emergency use authorization for its at-home test kit, which works in conjunction with a free software application to provide easy-to-read test results, company officials said. In a clinical study of nearly 200 volunteers, the test proved to be 95% accuracy when compared to laboratory PCR tests.
The kits include a sterile nasal swab, a dropper, processing fluid and a Bluetooth-connected analyzer for use with Ellume’s free app.
“As COVID-19 case numbers hit record highs, the world needs access to fast, affordable, easy-to-use home testing,” Ellume founder and CEO Sean Parsons said in December. “Ellume’s COVID-19 Home Test delivers this important first line of defense - it can be widely available without the need for a prescription, enabling the U.S. to respond to the pandemic in its most urgent stage.”
The U.S. continues to lead the world in COVID-19 cases with 26.1 million confirmed cases as of Monday afternoon, according to a tally from Johns Hopkins University. Nationwide, the virus has claimed more than 441,000 lives.
Globally, more than 103 million COVID-19 cases have been reported, resulting in 2.2 million deaths.