COVID-19 Breath Test Approved by Food and Drug Administration (FDA)

The company had affirmed the production of 100 devices a week, as per the FDA, with the first device hitting the market in 10 to 12 weeks.

“I think this is a really exciting development for the entire field of breath analysis. This is a huge step forward,” says Cristina Davis, the associate vice chancellor of Interdisciplinary Research and Strategic Initiatives at the University of California, Davis, who has been developing her coronavirus test.

Transition of Pandemic into Endemic

However, the FDA cautions that the test result should not be the sole basis for management/treatment strategies of COVID patients.

The breath test also has its own real-world challenges/limitations, partly due to its large size (about the size of a carry-on suitcase) and its use by only trained operators (supervised by health care professionals).

Nevertheless, this breath-based coronavirus test may be utilized as rapid and non-invasive viral-screening method for large groups of people.

“If you think back from the original PCR, those were pretty horrible,” Maldonado said. “They were very uncomfortable and seemed to last forever — the easier we can make it, the better off we are,” says Yvonne Maldonado, an infectious disease specialist at Stanford University School of Medicine who is working on another Breathalyzer test, affirming its role in the transition to the endemic phase of the pandemic.

Source: Medindia