Months after receiving FDA approval, the first at-home over-the-counter coronavirus test will receive $231.8 million from the government to boost production and increase distribution. The Ellume COVID-19 Home Test can be performed in as little as 15 minutes and involves a nasal swab with results reported via a smartphone app.
"These are over-the-counter, self-performed test kits that can detect COVID with roughly 95% accuracy within 15 minutes," Andy Slavitt, White House COVID-19 response team’s senior adviser, said in a press briefing held 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."
The test was approved for use in individuals ages 2 and older, and is less invasive than the traditional nasal swab.
"Making easier-to-use tests available to every American is a high priority with obvious benefits," Slavitt said.
Through the additional funding, Slavitt said Ellume will be able to increase manufacturing to product 19 million test kits per month by the end of 2021. The funding agreement has also secured 8.5 million tests for the U.S. government.
"The ability to quickly test, contact trace and quarantine is a linchpin of our national strategy and will be a vital part of containing the virus and stopping community spread," he said. "In the interim, and while vaccines are still being rolled out, as Dr. Walensky repeatedly reminds us, wearing a well-fitting mask is vital. Without masks the virus and new variants will have too easy a time continuing to grow."
According to a news release posted on Monday, the test was developed with support from the National Institutes of Health’s Rapid Acceleration of Diagnostics.