FDA Approves Over-the-Counter COVID-19 Test for Emergency Use

Officials at the U.S. Food and Drug Administration (FDA) formally authorized an over-the-counter, at-home coronavirus test for emergency use on Tuesday.

Developed by health care manufacturing company Ellume, the newly approved diagnostic assessment is the first of its kind to receive FDA clearance. Its authorization marks an important development for coronavirus testing procedures as the country continues to grapple with increasing transmission rates, surging hospitalization numbers and record fatalities as a result of the pandemic.

"Today's authorization is a major milestone in diagnostic testing for COVID-19," said Stephen Hahn, the FDA's commissioner, in a statement released alongside the agency's Tuesday announcement. "By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drugstores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes."

Before issuing an emergency use authorization for Ellume's antigen test, the FDA had approved 225 diagnostic assessments to detect infection. However, none were accessible without a prescription. Also, each of the 25 tests previously approved for at-home use required individuals to submit collected specimens to a laboratory before receiving their results.

Ellume's test offers a simpler, and faster, process for individuals to determine whether they are carrying the novel virus. It will allow users to collect their own nasal swab samples and subsequently screen them for proteins, called antigens, that signal an active coronavirus infection. The home-screening device is paired with a smartphone application that can provide results in roughly 20 minutes.

According to the FDA, Ellume's test kit proved highly accurate during clinical trials that preceded its approval for emergency use, accurately diagnosing 96 percent of positive specimens and 100 percent of negative specimens collected from symptomatic individuals. Accuracy figures for asymptomatic groups were slightly lower, with the home assessment correctly identifying 91 percent of positive cases and 96 percent of negative ones, the FDA said.

Ellume aims to produce and distribute 20 million of its tests to U.S. recipients during the first half of next year. In a statement released after the FDA confirmed its emergency use authorization, the company said it is accelerating manufacturing procedures and intends to dispatch at least 100,000 tests per day starting in January. The test's upcoming rollout will follow preliminary rounds of COVID-19 vaccine distribution, which commenced over the weekend after Pfizer and BioNTech's vaccine earned formal approval for emergency use from the FDA and the U.S. Centers for Disease Control and Prevention.

News of the at-home rapid test's upcoming availability comes several months into the most severe spike in U.S. virus cases reported this year. States across the country have seen infection counts rise rapidly throughout the fall, overwhelming hospital systems and setting new death records. More than 16.5 million people have tested positive for the virus in the U.S. as of Tuesday afternoon, and at least 301,500 have died from complications of its disease, COVID-19.

Newsweek reached out to the FDA for further comment but did not receive a reply in time for publication.

This story was updated at 2:19 p.m. ET to include additional details and background information.

Coronavirus, COVID-19 Test
A health care worker places a coronavirus nasal swab test into a specimen bag at Los Angeles International Airport on November 18. PATRICK FALLON/AFP via Getty Images