The Food and Drug Administration (FDA) issued emergency authorization Saturday for a novel coronavirus (COVID-19) test kit.
Called the "Cepheid Xpert Xpress SARS-CoV-2 test," it is made by Cepheid Inc. and gives results in 45 minutes instead of days. The test can be conducted entirely at the point of care. It has been designed to operate on any of Cepheid's more than 23,000 automated GeneXpert Systems worldwide, of which 5,000 are in the U.S. More, the systems do not require users to have specialty training to perform testing. The company plans to roll it out by March 30. Health and Human Services (HHS) Secretary Alex Azar added: "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."
Automated GeneXpert System
"Our automated systems do not require users to have specialty training to perform testing -- they are capable of running 24/7, with many systems already doing so today," Cepheid President Warren Kocmond explained. The test initially will be used primarily by hospitals. As of late Friday, there were nearly 20,000 confirmed cases of coronavirus in the U.S. and more than 246 confirmed deaths.