Under Biden’s administration, the Department of Defense and the Department of Health and Human Services (HHS) awarded an Australia-based company $ 230 million to scale up production of its home Covid test.
Ellume’s home tests, which received emergency use approval from the Food and Drug Administration (FDA) in December, were 95 percent accurate and gave users Covid-19 results within 15 minutes.
Andy Slavitt, a senior adviser to President Joe Biden’s Covid response team, announced the million dollar deal with Ellume at a news conference Monday.
“They can be used if you feel symptoms of Covid, as well as screening for people without symptoms so they can go to work, school and events safely,” Slavitt said. “After you take the cotton swab, you put the sample into a digital analyzer, which sends a result to your smartphone in about 15 minutes.”
The money from this deal would scale up production of the home test so it could be more accessible to Americans. The test is offered without a prescription for $ 30 per set and sends the results to the phone after use.
With the money, Ellume would be able to produce 19 million home-use test kits per month by the end of the year, 8.5 million of which are guaranteed to the federal government, Slavitt said. The company would ship 100,000 home-use test kits to the United States from February to July.
When the company received emergency approval in December, it was only producing about 16,000 tests per day.
This announcement comes because health officials have been pleading for months that testing should be easy and accessible to the public as a way of responding to the pandemic. Ellume’s home kit was one of three currently available, but it’s the only one that doesn’t require a doctor’s prescription.
The United States has prioritized the production, distribution and delivery of vaccines to respond to the pandemic over the past month. But there still needed to be an emphasis on testing so residents could isolate themselves if they test positive.
In addition to increasing production in the millions for its home tests, Ellume said on Monday it would use the funding to build a US-based factory. The company has not disclosed a timetable for when all of this would occur.
This new deal was funded through the Health Care Enhancement Act (HCEA) to support domestic manufacturing of essential medical devices.