CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
March 15, 2021—Cue Health has received FDA emergency use authorization for over-the-counter sale of its COVID-19 test. The Cue COVID-19 Test for Home and Over the Counter Use uses a lower nasal swab and provides results in about 20 minutes. The Cue OTC test is authorized for use by symptomatic and asymptomatic individuals, for ages two and older.
“With this authorization, consumers can purchase and self-administer one of the easiest, fastest, and most accurate tests without a prescription,” Clint Sever, cofounder and chief product officer of Cue, said in a press statement. “This FDA authorization will help us improve patient outcomes with a solution that provides the accuracy of central lab tests, with the speed and accessibility required to address emergent global health issues.”