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BioWorld - Sunday, May 3, 2026
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Home » FDA grants EUA for breath test for COVID, but impact on overall test volume is limited
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FDA grants EUA for breath test for COVID, but impact on overall test volume is limited

April 18, 2022
By Mark McCarty
The FDA has granted an emergency use authorization (EUA) to Inspect IR Systems LLC, of Frisco, Texas, for the company’s namesake test that evaluates the patient’s breath for the presence of volatile organic compounds (VOC) indicative of the SARS-CoV-2 virus. The test is expected to increase the volume of testing by only 64,000 per month at the current rate of production, however, making this a technological breakthrough of limited impact on the COVID-19 pandemic.
Medical technology Regulatory Diagnostics Coronavirus U.S. FDA

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