FDA authorizes new rapid COVID-19 test, says capacity will double

FDA authorizes new rapid COVID-19 test, says capacity will double
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The Food and Drug Administration (FDA) on Monday authorized a new rapid, at-home COVID-19 test, in a move it said is expected to double the availability of such tests in the coming weeks.

The FDA said it has authorized a coronavirus test from the company ACON Laboratories. It is not the first authorization of such a test, which can deliver results in as little as 15 minutes, but, amid supply shortages, the move could be key in boosting their availability.

Jeff Shuren, a top FDA official, said the move "is expected to double rapid at-home testing capacity in the U.S. over the next several weeks."


He said the company plans to produce more than 100 million tests per month by the end of the year and 200 million per month by February.

The Biden administration has come under pressure to do more to boost rapid, at-home testing capacity, an area where experts have been pushing for more action for months.

Rapid tests can, for example, help keep schools open safely.

Several senators pressed Health and Human Services Secretary Xavier BecerraXavier BecerraOvernight Health Care — Presented by the National Council for Mental Wellbeing — FDA panel endorses booster shots of Johnson & Johnson vaccine Biden administration to invest 0 million to boost health care, attract workers FDA guidance calls for voluntary salt reduction in food supply MORE about the need to improve the availability of rapid tests at a hearing last week.

Sen. Tim KaineTimothy (Tim) Michael KaineFill the Eastern District of Virginia  Defense & National Security — Military starts giving guidance on COVID-19 vaccine refusals Blinken pressed to fill empty post overseeing 'Havana syndrome' MORE (D-Va.) noted that in Germany, rapid tests are available at grocery stores for less than $1, and in the United Kingdom, everyone in the country has access to 14 free rapid tests, compared to about $15 in the U.S.

"Why are tests in the United States so much more expensive than in countries like Germany or the U.K. or India?" he asked.


The White House last month announced a $2 billion investment to ramp up testing capacity.

In an interview, Shuren, the FDA official, also pointed to investment as key to increasing supply.

"Investing in production and availability will drive more tests in the marketplace," he said.

"I think you've seen for other countries that have more tests coming on, those are the steps they've taken," Shuren added. "This is a case of economics. If you shore up the marketplace with guaranteed purchasing, large numbers, you can also bring down prices and you can increase availability."