FDA issues emergency authorization for COVID-19 breath test
The Food and Drug Administration issued an emergency use authorization (EUA) Thursday for the first COVID-19 diagnostic test using breath samples.
What they're saying: “Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the press release.
- “The FDA continues to support the development of novel COVID-19 tests with the goal of advancing technologies that can help address the current pandemic and better position the U.S. for the next public health emergency," Shuren added.
The big picture: The breathalyzer can provide results in less than three minutes, per the press release.
- InspectIR, the company behind the test, "expects to be able to produce approximately 100 instruments per week, which can each be used to evaluate approximately 160 samples per day."
Our thought bubble, from Axios' Tina Reed: This breathalyzer — which returns either negative results or an unconfirmed positive test that would need to be confirmed with a PCR test — won’t totally replace the nose swabs. But it could help rule out cases.