Mar 5, 2021 - Health

FDA authorizes over-the-counter coronavirus test

Jacob Knutson

A photo of someone performing a test with Cue Health's coronavirus test kit. Photo courtesy of Cue Health

The Food and Drug Administration on Friday issued an emergency use authorization for a COVID-19 test for home and other over-the-counter uses.

Why it matters: The single-use test, developed by Cue Health, may increase the availability of reliable coronavirus tests in the United States, potentially allowing Americans to avoid trips to the doctor’s office or a testing site.

By the numbers: The FDA said the test correctly identified 96% of positive coronavirus samples from individuals who had symptoms and correctly identified 100% of positive samples from asymptomatic people.

Cue Health expects to produce more than 100,000 tests each day by this summer, the FDA said.

What they're saying: "This is the first molecular diagnostic test available without a prescription," Ayub Khattak, co-founder and CEO of Cue, said in a statement Friday.

"For the first time, consumers can access laboratory-grade testing at home. This is an important milestone in the advancement of COVID-19 testing," he added.

The big picture: The FDA said it has authorized 336 tests and sample collection devices for the virus so far.

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FDA authorizes over-the-counter coronavirus test

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