The FDA just approved a new rapid coronavirus test that can diagnose the virus in 45 minutes

The FDA just approved a new rapid coronavirus test that can diagnose the virus in 45 minutes

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  • The US FDA on Saturday approved a new rapid coronavirus test by California-based Cepheid.
  • The test can detect the novel coronavirus within 45 minutes, and can be processed by providers without training on one of the company's 5,000 machines across the country.
  • On March 13, the FDA also gave emergency clearance for a test by Roche, which can diagnose COVID-19 in about three hours. Previously, patients have had to wait days for a diagnosis.
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The US Food and Drug Administration has approved a coronavirus test that can deliver a diagnosis in 45 minutes.

The test, made by California-based Cepheid, got emergency clearance on Saturday, eight days after the agency gave fast-track approval for a test by Roche, which can diagnose the novel coronavirus within three hours. Medical-equipment giant Thermo Fisher also has a test on the market.

The approval is part of a concerted effort to make up for lost time after delays, a flawed test, and then a global shortage of the essential chemicals needed to make a new test meant the US was testing its citizens at a far slower rate than other countries. States are now also implementing drive-through tests, which have proven successful in other countries, including South Korea.

The Cepheid test will be dispatched next week - first to hospitals, but the FDA's emergency clearance means it can be used in all care settings.


Crucially, providers will not need training to administer the test, which is processed on one of Cepheid's GeneXpert testing system, of which there are 23,000 worldwide and 5,000 in the US.

"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, chief medical and technology officer at Cepheid, said in a statement.

Read more:

The US is struggling to ramp up testing for the coronavirus. Here's how healthcare giants and startups are racing to help.

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