FDA Authorizes First Over-The-Counter Home Coronavirus Test

The Food and Drug Administration approved the first over-the-counter, at-home coronavirus test Tuesday.

The test, developed by the Australian company Ellume Limited, is a rapid antigen test that can deliver results in approximately 20 minutes, and works on any patient older than two years of age, the FDA said in its announcement.

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

The announcement follows the FDA’s approval of an at-home prescription coronavirus test in November. The agency has now authorized over 225 coronavirus tests since the pandemic began, according to its release.

The FDA on Tuesday also released data reaffirming the safety and effectiveness of Moderna’s coronavirus vaccine, clearing the way for its emergency approval later this week. A vaccine advisory panel will meet Thursday to scour Moderna’s data before voting on whether to recommend it for emergency use.

The process is to FDA’s actions last week on Pfizer’s vaccine. The FDA released Pfizer’s data Dec. 8, the panel voted to recommend its authorization Thursday, and it was officially granted emergency approval late Friday.

Pfizer’s vaccine began to be distributed over the weekend, and administration started Monday in states across the country. Officials have said that Moderna is prepared to distribute 6 million vaccine doses, over twice the amount initially distributed from Pfizer, meaning that its coming emergency authorization could help alleviate the extraordinary demand for safe and effective vaccines as virus cases, hospitalizations and deaths spike across the country.

The U.S. surpassed 300,000 total coronavirus-related deaths Monday, according to Johns Hopkins University.