FDA Clears Cepheid’s On-Demand Coronavirus Test for Emergency Use

The FDA granted Cepheid an emergency use authorization for its Xpert Xpress SARS-CoV-2 point-of-care rapid diagnostic test.

The test, which was designed based on the company’s Flu/RSV testing cartridge product, can deliver results within hours and can be taken at patient care settings instead of relying on a lab to analyze samples.

The test runs on Cepheid’s GeneXpert system, a platform that doesn’t require special training. The company said the tests will be available by the end of the month.