Kisha Smith

Since the onset of the COVID-19 pandemic, the development of diagnostics and drugs to test and treat it have led a revolution in medical research and a deluge of new therapies in the pipeline. Among them is a breath test that can detect the coronavirus in less than three minutes.

Yesterday (April 14), the U.S. Food and Drug Administration issued an emergency use authorization for the InspectIR COVID-19 Breathalyzer that must be performed by a qualified, trained operator.

“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “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.”

The test was found to have 91.2% accurate in the identification of positive test samples and 99.3% accurate in correctly identifying negative samples which is expected to increase testing capacity by approximately 64,000 samples per month.

It will take time for the devices to be produced in mass quantity, but they are projected to hit the market by mid-summer.