PR Newswire03.23.20
Cepheid has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for Xpert Xpress SARS-CoV-2, a rapid molecular diagnostic test for qualitative detection of SARS-CoV-2, the virus causing COVID-19. The test has been designed to operate on any of Cepheid's more than 23,000 automated GeneXpert Systems worldwide, with a detection time of approximately 45 minutes.
"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," said Dr. David Persing, M.D., Ph.D., chief medical and technology officer at Cepheid. "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 test will begin shipping this week. The test cartridge is a complete solution containing all the necessary reagents. A patient sample is loaded into the cartridge and a GeneXpert System is required to run the test. This is different from some other test kits on the market which may require additional reagents such as extraction materials. Appropriate sample types for testing include nasopharyngeal swabs (NPS) in UTM/VTM, nasal aspirates, and nasal washes.
"Cepheid currently has nearly 5,000 GeneXpert Systems in the U.S. capable of point-of-care testing and for use in hospitals," said Cepheid President Warren Kocmond. "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 has a history of responding quickly and working with global health organizations to help manage infectious disease outbreaks, such as Ebola virus and 2009 H1N1 influenza.
"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," said Dr. David Persing, M.D., Ph.D., chief medical and technology officer at Cepheid. "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 test will begin shipping this week. The test cartridge is a complete solution containing all the necessary reagents. A patient sample is loaded into the cartridge and a GeneXpert System is required to run the test. This is different from some other test kits on the market which may require additional reagents such as extraction materials. Appropriate sample types for testing include nasopharyngeal swabs (NPS) in UTM/VTM, nasal aspirates, and nasal washes.
"Cepheid currently has nearly 5,000 GeneXpert Systems in the U.S. capable of point-of-care testing and for use in hospitals," said Cepheid President Warren Kocmond. "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 has a history of responding quickly and working with global health organizations to help manage infectious disease outbreaks, such as Ebola virus and 2009 H1N1 influenza.