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FDA has given the primary crisis use approval for a state of-care covid-19 demonstrative. The approval was given for the Xpert Xpress SARS-CoV-2 test from Cepheid, Sunnyvale, Calif. “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.”
“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 organization’s EUA awards consent for the Xpert Xpress SARS-CoV-2 to be utilized in high-and moderate-multifaceted nature CLIA-affirmed research centers just as in certain patient consideration settings. The organization expects to turn out accessibility of its place of-care test by March 30.
