The Food and Drug Administration approved a rapid coronavirus test on Saturday that will deliver results in about 45 minutes. The test will be available in the next few weeks and no training will be necessary to administer the tests.
Cepheid, a California-based diagnostic testing company, announced on Saturday that the FDA approved the use of its XpertXpress Sars-CoV-2 rapid molecular diagnostic test for the detection of the Chinese coronavirus that causes COVID-19. The test is designed to work on any of the company’s more than 23,000 automated worldwide testing systems. The test provides results in about 45 minutes, company officials said in a written statement.
“During this time of increased demand for hospital services, Clinicians urgently need an on-demand diagnostic test for real-time management of patients being evaluated for admission to health-care facilities. An accurate test delivered close to the patient can be transformative — and help alleviate the pressure that the emergence of the 2019-nCoV outbreak has put on healthcare facilities that need to properly allocate their respiratory isolation resources,” Dr. David Persing, MD, Ph.D., Chief Medical and Technology Officer at Cepheid said in the statement. “By leveraging the design principles of our current Xpert Xpress Flu/RSV cartridge technology, in which multiple regions of the viral genome are targeted to provide rapid detection of current and potential future variants of SARS-CoV-2, we have developed a test that provides reference lab-quality results in multiple settings where actionable treatment information is needed quickly.”
The company states it currently has nearly 5,000 of its GeneXpert Systems located across the U.S. that are capable of point-of-care testing.
“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,” HHS Secretary Alex Azar said in a Saturday press release. “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 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 added.
The company says it will begin shipping the tests next week.
“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,” FDA Commissioner Stephen Hahn, M.D. concluded. “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.”
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