On Friday, the Food and Drug Administration issued an emergency use permit for a COVID-19 test for domestic and other over-the-counter use.
Why it’s important: The single-use test, developed by Cue Health, may increase the availability of reliable coronavirus testing in the United States, which may allow Americans to avoid trips to the office or test site.
By numbers: The FDA said the test correctly identified 96% of positive coronavirus samples from people with symptoms and correctly identified 100% of positive samples from asymptomatic people.
- Cue Health expects to produce more than 100,000 tests each day this summer, the FDA said.
What they say: “This is the first molecular diagnostic test available without a prescription,” Ayub Khattak, co-founder and CEO of Cue, said Friday.
- “For the first time, consumers can access lab tests at home. This is an important milestone in the advancement of COVID-19 testing,” he added.
The big picture: The FDA said it has so far authorized 336 tests and sampling devices for the virus.