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