The Food and Drug Administration issued an emergency use permit on Friday for a COVID-19 test for household and other non-prescription 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, allowing potential Americans to avoid traveling to the doctor’s office or a 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 by this summer, the FDA said.
What are they saying: “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 laboratory tests at home. This is an important step in advancing COVID-19 testing,” he added.
The whole picture: The FDA said it has so far authorized 336 tests and sampling devices for the virus.