FDA has issued the first emergency use authorization for a point-of-care covid-19 diagnostic. The authorization was issued for the Xpert Xpress SARS-CoV-2 test from Cepheid, Sunnyvale, Calif.
Alex M Azar II, JD, US Department of Health and Human Services.
“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,” said Alex Azar, JD, secretary of health and human services.
“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,” added 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.”
Stephen M. Hahn, MD, FDA.
“Our dedicated team at 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, MD. “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 agency’s EUA grants permission for the Xpert Xpress SARS-CoV-2 to be used 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 test by March 30.
For further information, visit FDA.
