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Cepheid Coronavirus Assay First Point-of-Care Test to Get FDA Emergency Use Authorization

This story has been updated from a previous version to include information about the platforms on which Cepheid's test can be run.

NEW YORK – The US Food and Drug Administration on Friday issued Emergency Use Authorization for Cepheid's Xpert Xpress SARS-CoV-2 test for diagnosing COVID-19.

It is the first EUA for a SARS-CoV-2 that can be used at the point of care. In addition to high- and moderate-complexity laboratories, the rapid molecular test can be used in certain patient-care settings, the agency said.

"The test we're authorizing today will be able to provide Americans with results within hours, rather than days like the existing tests," US Health and Human Services Secretary Alex Azar said in a statement. "With new tools like point-of-care diagnostics, we are moving into a new phase of testing, where tests will be much more easily accessible to Americans who need them."

According to David Persing, chief medical and technology officer at Sunnyvale, California-based Cepheid, the company leveraged its Xpert Xpress Flu/RSV cartridge technology, which targets multiple regions of the viral genome, to detect current and potentially new variants of SARS-CoV-2, the coronavirus which causes COVID-19.

The test is designed for use with Cepheid's GeneXpert Dx and GeneXpert Infinity Systems in authorized moderate- and high-complexity labs. In addition, beginning March 30, the test will be available for use on Cepheid's GeneXpert Xpress system, which is CLIA waived. Globally, there are 23,000 GeneXpert Systems, including 5,000 in the US. Results from the Xpert Xpress SARS-CoV-2 can be obtained in about 45 minutes, the firm said.

Cepheid, which is part of Danaher, will begin shipping the test in the coming week.

The EUA issuance comes as the US tries to meet an acute need for SARS-CoV-2 testing. As of Saturday evening, there were more than 24,000 confirmed cases of COVID-19 in the country, with the figure expected to spike in coming weeks as the backlog of patient tests gets smaller. Cepheid joins an expanding list of commercial test makers that have received EUAs for their SARS-Cov-tests, including Roche, Thermo Fisher Scientific, Abbott, Quidel, Hologic, GenMark Diagnostics, and DiaSorin Molecular.

Meanwhile, other companies developing point-of-care diagnostic tests for SARS-CoV-2 include Credo Diagnostics, Mologic, Iceni Diagnostics, and Chembio Diagnostics.