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 COVID-19 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. 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,” said Stephen Hahn, commissioner at the FDA, in a statement released alongside the agency’s Tuesday announcement.
Prior to issuing an emergency use authorization for Ellume’s COVID-19 antigen test, the FDA had approved 225 diagnostic assessments to detect infection. However, none were accessible without a prescription, and each of the 25 tests previously approved for at-home use required individuals to submit collected specimens to a laboratory before receiving their results.
This is a developing story and will be updated as more information becomes available.
The U.S. Food and Drug Administration approved the first over-the-counter, at-home COVID-19 diagnostic test for emergency use on Tuesday. A health care worker places a COVID-19 nasal swab test into a specimen bag at Los Angeles International Airport (LAX) in Los Angeles, California, on November 18. PATRICK FALLON/AFP via Getty Images
