The diagnostic assessment will be the first available for use without a prescription or laboratory screening requirement.
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.
