Cepheid Receives Emergency Use Authorization (EUA) from the FDA for Rapid SARS-CoV-2 Test — Diagnostic Test for Coronavirus COVID-19


Cepheid’s Chief Medical Officer, Dr. David Persing, discusses Cepheid’s new diagnostic test for qualitative detection of SARS-CoV-2, the virus causing COVID-19.

Cepheid today 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 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.

Cepheid systems are already located in many if not most hospitals in the United States, and are already used for tuberculosis and HIV diagnosis. A new cartridge, announced Saturday, March 21, 2020, will accept a possible SARS-CoV-2 sample for analysis in existing Cepheid systems.

“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, MD, 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.”

“Cepheid currently has nearly 5,000 GeneXpert® Systems in the US 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.”

The test will begin shipping next week. For more information about Cepheid’s Xpert Xpress SARS-CoV-2 test, please visit www.cepheid.com/coronavirus.

Dr. David Persing gives an update on Cepheid’s development of an expected rapid test for SARS-CoV-2.

The GeneXpert System is a system to combine on-board sample preparation with a laboratory technique of molecular biology that uses real-time PCR (polymerase chain reaction) amplification of a targeted DNA molecule, and detection functions for fully integrated and automated nucleic acid analysis. Cepheid uses a closed, self-contained platform to minimize contamination risks.

Cepheid Inc., founded in 1996, has worked on pandemics before, and developed an Ebola test in five months. The company apparently reached its goal to break record time with establishment of the SARS-CoV-2 diagnostic test. Cepheid Inc, a molecular diagnostic company that develops, manufactures and markets fully-integrated systems for testing infectious organisms, including viruses, and also genetic-based diseases. Cepheid Inc. develops automated systems for otherwise complex manual laboratory tasks and procedures.

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