I have a friend that has been quarantined to her bedroom for so long now! Her coronavirus test results that she was told would take a few days are delayed. So she sits and she waits. It isn’t fun not knowing and being so alone.
Yesterday I read about Cepheid from California. They have received a EUA from the FDA on a test that could give results in about 45 minutes!
A EUA means an Emergency Use Authorization. This is the first emergency use authorization for a point-of-care COVID-19 diagnostic 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. 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.HHS Secretary Alex Azar
This will be so helpful, I mean people are waiting so long for results and the virus continues to spread.
This emergency use authorization from the FDA was approved for Cepheid for the Xpert Xpress SARS-CoV-2 test.
This test is for use in high and moderate complexity CLIA-certified laboratories as well as some patient care settings.
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. 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.FDA Commissioner Stephen Hahn, M.D.
This will be a game-changer for testing! Quick results are important for proper care and even our mental health state! Worrying about results is very difficult to deal with for days!
The company intends to have the tests available for its point-of-care testing by March 30. You can learn more on the FDA website.