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Covid-19

 

A newly authorized point-of-care diagnostic could cut the wait for a COVID-19 diagnosis from days to hours, the US Food and Drug Administration announced on 21 March.

The Xpert Xpress SARS-CoV-2 test, developed by Danaher Corp. business unit Cepheid, uses samples collected via a nasal swab or nasal wash, and offers results in as little as 45 minutes. It can be used with any existing Cepheid GeneXpert system.

The FDA issued an Emergency Use Authorization (EUA) on the test for use in high- and moderate-complexity CLIA-certified laboratories, as well as in certain patient-care settings. The agency’s Letter of Authorization  for Cepheid’s test was posted alongside the announcement.

The company plans to begin shipping the COVID-19 test on 30 March.

“With the development of point-of-care diagnostics, Americans who need tests will be able to get results faster than ever before. 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,” US Department of Health and Human Services secretary Alex Azar said in a statement.

Cepheid says the COVID-19 diagnostic uses design principles from the Xpert Xpress Flu/RSV cartridge technology, which targets multiple regions of the viral genome to rapidly detect current and potential future variants of SARS-CoV-2. The company plans to begin shipping the COVID-19 test on 30 March.

Cepheid chief medical officer David Persing first announced in February that Cepheid was working on a rapid-response diagnostic that would make use of the flu test technology.  (Also see "Performance Issues With CDC’s COVID-19 Assay Reagent Slows Rollout Of Test Kits To US States" - Medtech Insight, 19 Feb, 2020.)

According toMedtech Insight’s COVID-19: Global Test Pipeline tracker, this is the tenth COVID-19 diagnostic to be granted an EUA.

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