FDA Authorizes First Covid Breath Testing Device

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The Food and Drug Administration issued an emergency use authorization Thursday for InspectIR Systems’ “Covid-19 breathalyzer,” the first government-approved device capable of detecting coronavirus infections in patients’ breath.

The FDA has authorized the first Covid-19 breath test.

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Key Facts

The breathalyzer correctly identified positive samples 91.2% of the time in a study of 2,409 people, and it also performed well in a subsequent study assessing its effectiveness against the virus’ omicron variant, according to an FDA release

The breath test provides results in under three minutes, and can be administered at either healthcare facilities or mobile testing sites using an instrument roughly the size of an item of carry-on luggage, the agency said.

InspectIR projects it will eventually be able to produce about 100 Covid-19 breathalyzers per week, each of which could perform about 160 tests per day, the FDA said.

At InspectIR’s current levels of production, the Covid-19 breathalyzer should boost the U.S.’s testing capacity by about 64,000 samples each month, the agency said.

Key Background

InspectIR’s breathalyzer detects compounds associated with Covid-19 infection using gas chromatography-mass spectrometry, a technique for analyzing chemicals that is used in everything from monitoring for food contamination to measuring the atmosphere of Venus. The company’s breath-testing technology can also be used to detect chemical markers for influenza infection, CEO Tim C. Wing said in a 2020 press release. Accuracy has been an obstacle for developers of new Covid-19 tests, but InspectIR believes its technology circumvents this problem by testing in the high part-per-trillion range, the company’s COO John Redmond said in the press release. Trial results published by the FDA appear to bear this out, reporting 99.6% accuracy at identifying Covid-negative samples.

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