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FDA approves first COVID-19 breath diagnostic test

Food and Drug Administration
Posted at 5:47 PM, Apr 14, 2022
and last updated 2022-04-14 17:47:25-04

The U.S. Food and Drug Administration (FDA) has just approved an emergency use authorization to bring the first breath COVID-19 diagnostic test to market.

The test detects chemical compounds in the breath which are associated with SARS-CoV-2 infection, the FDA said in a statement.

Samples will be collected and analyzed in environments like a doctor's office, mobile testing sites, and hospitals the agency said. They will have to be performed by a trained healthcare provider, and results can be returned in less than three minutes the FDA said.

Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health said in a statement, “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.” 

Earlier in April, President Joe Biden announced that his administration would be ordering a new national research push on long COVID-19, while also directing federal agencies to support patients dealing with the mysterious and debilitating condition.

The White House said Biden ordered the Department of Health and Human Services to coordinate an urgent new initiative across federal agencies, building on research already underway at the National Institutes of Health. The president also directed federal agencies to support patients and doctors by providing science-based best practices for treating long COVID, maintaining access to insurance coverage, and protecting the rights of workers coping with the condition.