FDA approves first bedside COVID-19 test by Danaher’s Cepheid

A Covid-19 test can deliver results in less than an hour has been approved under an FDA emergency authorization, marking the first test that clinicians can use at the bedside.

Cepheid, a Silicon Valley molecular diagnostics company that’s a unit of Danaher Corp., announced Saturday it received an emergency authorisation from the U.S. Food and Drug Administration to use the test, making it the 13th Covid-19 test the agency has allowed on the market as long as the public health emergency exists.

But it’s the first one that can be used at the point of care, meaning providers don’t have to send patient samples to a separate lab to be processed and then come back to the hospital or provider’s office. Cepheid said it expects to start shipping tests next week.

“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,” said David Persing, Cepheid Chief Medical and Technology Officer.

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Source: Bloomberg, 21 March 2020