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