Coronavirus: Deal struck to bring first over-the-counter COVID-19 tests to US

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.

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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.

“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.”

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.

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.