Man swabs nose for COVID-19 in driver's seat of car

Cue Health Inc., a healthcare technology company, recently disclosed that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for over-the-counter sale of its COVID-19 test. It is the “nation’s first first molecular diagnostic test available to consumers without a prescription,” the company said.

The test uses a lower nasal swab with results provided to the user’s mobile smart device in about 20 minutes. The test is for symptomatic and asymptomatic individuals, adults and children ages 2 and older, with adult assistance. Results from the Cue tests were comparable to FDA-EUA polymerase chain reaction (PCR) lab tests (97.4% agreement for positive cases and 99.1% agreement for negative cases), the company said. PCR is considered the gold standard in COVID-19 testing. 

“With this  FDA authorization, we are one step closer to achieving our mission of making molecular diagnostic testing available to anyone, anywhere, at any time through a connected healthcare delivery ecosystem,” said Ayub Khattak, co-founder and CEO of Cue.

The introduction of molecular testing, which is perceived to be more accurate than rapid testing, could have implications for home care, which is working to rebound from the pandemic. Testing is critical to help stem the spread of COVID-19.