FDA Approves Coronavirus Test With Rapid Results
WASHINGTON — The U.S. Food and Drug Administration has approved the first rapid coronavirus test, which produces results in about 45 minutes, according to Cepheid.
An FDA spokeswoman confirmed the approval after an announcement from the Silicon Valley molecular diagnostics company.
It can take at least a few days to get results from current coronavirus tests, which typically are sent in batches to reference labs, said Dr. David Persing, Cephied’s chief medical and technology officer.
“With the development of point of care diagnostics, Americans who need tests will be able to get results faster than ever before," Health and Human Services Secretary Alex Azar said in a statement. "More and more options for reliable, convenient testing are becoming available at an incredibly rapid pace, thanks to the hard work of our FDA team and the ingenuity of American industry.”
Cepheid said it will begin shipping its tests next week with roll-out availability by March 30.
“Our dedicated team at the FDA has been working nonstop to expedite the review and authorization of novel diagnostics during the COVID-19 public health emergency,” said FDA Commissioner Dr. Stephen Hahn in a statement.