Andy Slavitt, senior adviser on the White House COVID-19 Response Team, announced Monday that The Department of Defense (DOD) and The Department of Health and Human Services (HHS) are funding a project that will make home tests for COVID-19 available to millions of people by the end of 2021.
The Biden administration awarded $231.8 million to Ellume USA LLC, which initially got the green light from the Trump administration, to increase the production of the home test. During a press briefing Monday, Slavitt said that the over-the-counter, self-performed test kits give 95 percent accurate test results within 15 minutes.
“Ellume has been ramping up manufacturing and will ship 100,000 test kits per month to the U.S. from February through July,” Slavitt said during a White House briefing on Monday. “That’s good, but it’s obviously not where we will need to be.”
“So, I’m excited to announce it today, the Department of Defense and HHS has awarded $230 million to Ellume, in order to scale the manufacturing base and capacity of this easy-to-use test,” added Slavitt. “Thanks to this contract, they’ll be able to scale their production to manufacture more than 19 million test kits per month by the end of this year, 8.5 billion of which are guaranteed to the U.S. government.”
The tests are made by Ellume, a Digital diagnostics company based in Australia. The company was given an emergency authorization in December by the U.S. Food and Drug Administration (FDA) for a non-prescription Ellume COVID-19 Home Test for use in symptomatic and asymptomatic individuals, by people aged two years and older.
“The test is performed in what is called a mid-terminate nasal swab, which basically means it’s less invasive than the long nasal pharyngeal swab, that people may have seen on the news. After you take the swab. You put the sample into a digital analyzer, which will send a result to your smartphone in about 15 minutes,” said Slavitt.
The Trump administration’s Operation Warp Speed gave Ellume the go-ahead for production of the home test
In a December press statement, Ellume announced the green light from the United States’ FDA. “As COVID-19 case numbers hit record highs, the world needs access to fast, affordable, easy-to-use home testing,” said Ellume founder and CEO, Dr. Sean Parsons. “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.”
“Today’s authorization is a major milestone in diagnostic testing for COVID-19. By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes,” said then-FDA Commissioner Stephen Hahn in a Dec. 15 press statement.