FDA Approves First Bedside Covid-19 Test by Cepheid

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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.

Testing shortages have been an ongoing challenge in the U.S. response to curb the pandemic. The White House has promised testing will ramp up as more private companies come on board. Public health and clinical labs have run more than 195,000 tests to date, but that doesn’t include hospital laboratories running their own test, Brett Giroir, assistant secretary for health at the U.S. Department of Health and Human Services, said during a White House briefing Saturday.

Cepheid, a Silicon Valley diagnostics company, announced Saturday it received an emergency authorization from the 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,” David Persing, Cepheid chief medical and technology officer.

To contact the reporter on this story: Jeannie Baumann in Washington at jbaumann@bloomberglaw.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloomberglaw.com; Cheryl Saenz at csaenz@bloombergtax.com

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