US rapid, at-home COVID-19 test supply to quadruple by December, White House says

The U.S. supply of rapid, at-home COVID-19 tests is set to quadruple by December, the White House said Oct. 6, according to The Hill

The boost in supply is due to a number of factors, including the FDA's authorization of a new rapid, at-home COVID-19 Oct. 4. The test, made by San Diego-based Acon Laboratories, delivers results in as little as 15 minutes. 

Jeff Shuren, MD, director of FDA's Center for Devices and Radiological Health, said in a news release that the test's authorization "is expected to double rapid at-home testing capacity in the U.S. over the next several weeks."

Acon said it plans to manufacture more than 100 million tests per month by the end of the year and 200 million per month by February. 

The White House also announced an additional $1 billion investment in rapid testing Oct. 6, building on a $2 billion investment announced in September, The New York Times reported. 

A White House official told The Hill monthly production of rapid tests in the U.S. will increase from about 30 million to 200 million starting in December and that the prices of tests are expected to drop. 

The announcement comes as Ellume, an Australian company that was the first to receive FDA authorization to sell its rapid, at-home COVID-19 test at retail stores in the U.S., recalled hundreds of thousands of its tests because of an unexpectedly high volume of false positives. 

The company said Oct. 5 it has "isolated the cause and confirmed that this incidence of false positives is limited to specific lots." Forty-three lots were recalled. 

"You have my personal commitment that we have learned from this experience, we have implemented additional controls, we are continuing to work on resolving the issue that led to this recall, and we are going to do everything in our power to regain your trust," Ellume CEO Sean Parsons said in a news release

 

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