FDA authorizes first fully at-home, over the counter COVID-19 test

The Food and Drug Administration (FDA) has approved the first over the counter, fully at-home test for COVID-19. 

The test is made by a company called Ellume.

There will be limitations on supply and cost could be a barrier to widespread, repeated use.

“Today’s authorization is a major milestone in diagnostic testing for COVID-19,” said FDA Commissioner Stephen Hahn.

“By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes.”

“This test, like other antigen tests, is less sensitive and less specific than typical molecular tests run in a lab,” said Jeff Shuren, head of the FDA device center.

“However, the fact that it can be used completely at home and return results quickly means that it can play an important role in response to the pandemic.” 

Shuren said the FDA hopes to keep working to get new rapid tests on the market.

“Today is a promising step forward and we are eager to continue advancing additional innovation in COVID-19 testing that the science supports,” he said.

Market implications

More testing will undoubtedly result in even more positive cases and weigh on risk sentiment. However, the longer-term aim is to bring down the swells of the waves and contain the virus.

Detecting and isolation are what some experts advocate is the best method at stopping the spread of the virus, which is ultimately a positive outcome for markets.