Coronavirus COVID-19 Update - - - FDA Issues first Emergency Use Authorization for Point of Care Diagnostic | site |




(March 21, 2020) - - The U.S. Food and Drug Administration published today (March 21, 2020) the following information:

Today, the U.S. Food and Drug Administration issued the first emergency use authorization for a point-of-care COVID-19 diagnostic for the Cepheid Xpert Xpress SARS-CoV-2 test.

“The test we’re authorizing today will be able to provide Americans with results within hours, rather than days like the existing tests, and the company plans to roll it out by March 30, which is an incredibly rapid timeline for such an effort. 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,” said HHS Secretary Alex Azar. “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.”

“Our dedicated team at the FDA has been working nonstop to expedite the review and authorization of novel diagnostics during the COVID-19 public health emergency,” said FDA Commissioner Stephen Hahn, M.D. “Today marks an important step in expanding the availability of testing and, importantly, rapid results. Point-of-care testing means that results are delivered to patients in the patient care settings, like hospitals, urgent care centers and emergency rooms, instead of samples being sent to a laboratory. With today’s authorization, there is now an option for testing at the point of care, which enables patient access to more immediate results.”

The FDA issued an emergency use authorization to Cepheid for the Xpert Xpress SARS-CoV-2 test for use in high- and moderate-complexity CLIA-certified laboratories as well as in certain patient care settings. The company intends to roll-out availability of its point-of-care testing by March 30.