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.
“What’s really needed is a test that can rapidly determine status of infection on site when patients are being seen,” he said on a company video. "An accurate test delivered close to the patient can be transformative — and help alleviate the pressure that the emergence of the 2019-nCoV outbreak has put on healthcare facilities that need to properly allocate their respiratory isolation resources."
“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.