FDA Authorizes New At-Home Rapid COVID-19 Test, Expects Capacity to Double in US

A sign for the Food and Drug Administration is seen outside of the headquarters in White Oak, Maryland, on July 20, 2020. (Sarah Silbiger/Getty Images)

Food and Drug Administration (FDA) said Monday it authorized a new聽over-the-counter聽COVID-19 rapid antigen test that聽“is expected to double rapid at-home testing capacity in the U.S. over the next several weeks.”

FDA’s聽emergency use authorization is for the ACON Laboratories Flowflex COVID-19 Home Test, which can be聽used at home without a prescription.

ACON, a聽San Diego-based company,聽plans to produce more than 100 million tests per month, and 200 per month by February 2022,聽the FDA聽said in a statement.

test involves collecting nasal swabs and yields results within about 15 minutes鈥攎uch shorter than聽PCR (polymerase chain reaction) tests, which take 1-5 days to do so.

White House COVID-19 Response Coordinator Jeff Zients acknowledged on Oct. 1 that聽at-home rapid test is “under a lot of demand” but that manufacturing would scale up and double across the next several months.

“We鈥檙e just going to keep at it to encourage those manufacturers to increase capacity and to drive down the cost of those tests,” he added. “So, we will continue to pull every lever we can to increase the convenience of rapid at-home testing.”

It comes as the Department of Defense the same day announced聽that its logistics agency awarded six contracts with a combined value of over $2.78 billion for 150 million at home and 400 million point-of-care test COVID-19 test kits. move is in support of the Biden administration’s efforts to combat COVID-19.

Pezou : FDA Authorizes New At-Home Rapid COVID-19 Test, Expects Capacity to Double in US