45-Minute SARS-CoV-2 Test Approved

A California company announced it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) for Xpert® Xpress SARS-CoV-2, a rapid molecular diagnostic test.

Announced on March 21, 2020, this innovative test is for the qualitative detection of the SARS-COV-2 coronavirus, which causes COVID-19 disease and is scheduled to begin shipping to customers in March 2020.

The Xpert® Xpress SARS-CoV-2 test has a detection time of approximately 45 minutes, with less than a minute of hands-on time to prepare the sample.

Appropriate sample types for testing include nasopharyngeal swabs in UTM/VTM, nasal aspirates, and nasal washes.

Dr. David Persing, M.D., Ph.D., Chief Medical and Technology Officer at Cepheid said in a press release issued on March 21, 2020, "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."

"Cepheid currently has nearly 5,000 GeneXpert® Systems in the USA capable of point-of-care testing and for use in hospitals,"

“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,” concluded this press release.

Hospitals and labs currently using a GeneXpert system will be able to run the tests. It’s up to the healthcare professionals at those facilities to determine who meets the criteria for being tested.

The test leverages the design principles of our current Xpert® Xpress Flu/RSV cartridge technology, in which multiple regions of the viral genome are targeted.

Cepheid has a history of responding quickly and working with global health organizations to help manage infectious disease outbreaks, such as the Ebola virus and 2009 H1N1 influenza.

Cepheid is a leading molecular diagnostics company that is an operating company within Danaher Corporation's Diagnostics platform. For more information about Cepheid's Xpert Xpress SARS-CoV-2 test, please visit Cepheid.

The EUA authority under section 564 allows the FDA to facilitate availability and unapproved uses of medical countermeasures needed to prepare for and respond to Chemical, Biological, Radiological, or Nuclear emergencies.

SARS-CoV-2 outbreak news is published by Coronavirus Today.

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