President Biden approves Covid test kits that are 95% accurate

Under the Biden administration, the Department of Defence and Department of Health and Human Services (HHS) have awarded an Australian-based company $230 million (£168 million) to scale up the manufacturing of its at-home Covid test. 

Ellume’s at-home tests, which received emergency use authorisation from the Food and Drug Administration (FDA) in December, were 95 per cent accurate and provided users with Covid-19 results within 15 minutes. 

Andy Slavitt, a senior adviser to President Joe Biden’s Covid response team, announced the million-dollar deal struck with Ellume during a press briefing on Monday. 

“They could be used if you feel symptoms of Covid, and also for screening for people without symptoms so they could safely go to work, to school, and to events,” Mr Slavitt said. “After you take the swab, you put the sample into a digital analyser, which will send a result to your smartphone in about 15 minutes.”

The money from this deal would scale-up the manufacturing of the at-home test so it could be more accessible to Americans. The test is offered over the counter at $30 per kit and sends the results to one’s phone. 

With the money, Ellume would be able to produce 19 million at-home testing kits per month by the end of the year, 8.5 million of which were guaranteed for the federal government, Mr Slavitt said. The company would ship 100,000 at-home testing kits to the United States per month from February to July. 

When the company received emergency use authorisation in December, it was manufacturing only about 16,000 tests per day. 

This announcement comes following months of pleas from health officials for testing to be easy and accessible to the public as a way to respond to the pandemic. Ellume’s at-home kit is one of three currently available, but its the only one that doesn’t require a doctor’s prescription to purchase. 

The Unites States has prioritised vaccine manufacturing, distributing, and administering in the last month to respond to the pandemic. But an emphasis is still needed on testing so residents can isolate themselves if they test positive. 

Besides increasing manufacturing in the millions for its at-home tests, Ellume said on Monday it would use the funding to construct a US-based plant. The company did not reveal a timeframe for when this would all take place. 

This new deal was funded through the Health Care Enhancement Act (HCEA), to support domestic production of critical medical resources.

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