FDA Authorizes New 45 Minute Coronavirus Test for Release Next Week

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A California-based molecular diagnostics company announced Saturday they will ship a point-of-care test next week that they say can detect SARS-CoV-2, the virus causing COVID-19 in 45 minutes.

Officials at the U.S. Food and Drug Administration gave that company, Cepheid, Emergency Use Authorization to do so, company officials said in a press release.

Called the Xpert Xpress SARS-CoV-2, the test is designed to operate on any of Cepheid’s more than 23,000 automated GeneXpert Systems worldwide, with a detection time of less than one hour.

“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 President Warren Kocmond said the company currently has nearly 5,000 GeneXpert Systems in the United States 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,” Kocmond said.

As The Star reported Sunday, the coronavirus has taken a toll on the U.S. economy and even prompted some governors to impose mandatory shutdowns of nonessential businesses in their respective states. Those governors said non-essential businesses include, among other place, dine-in restaurants, bars, nightclubs, entertainment venues, gyms, and hair and nail salons.

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Chris Butler is an investigative journalist at The Tennessee Star. Follow Chris on Facebook. Email tips to [email protected]
Photo “Xpert Xpress SARS-CoV-2” by Cepheid.

 

 

 

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