The Food and Drug Administration on Friday issued an emergency use authorization for a COVID-19 test for home use and other over-the-counter uses.
Why does it matter: The single-use test, developed by Cue Health, can increase the availability of reliable coronavirus tests in the United States, potentially allowing Americans to avoid visits to the doctor’s office or a test site.
By the numbers: The FDA said the test correctly identified 96% of positive samples of coronavirus 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 a day by the summer, the FDA said.
What they are saying: “This is the first molecular diagnostic test available over the counter,” said Ayub Khattak, co-founder and CEO of Cue, in a statement on Friday.
- “For the first time, consumers can access lab-level 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.