FDA Authorizes Use of Diagnostics Company Cepheid's Rapid Coronavirus Tests

MOSCOW (Sputnik) - Cepheid, a molecular diagnostics company based in the United States, announced on Saturday it had received authorization from the US Food and Drug Administration (FDA) for tests capable of detecting the coronavirus strain that causes COVID-19 in 45 minutes.

"Cepheid today announced it has received Emergency Use Authorization (EUA) from the US Food & Drug Administration (FDA) for Xpert® Xpress SARS-CoV-2, a rapid molecular diagnostic test for the 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", the company said in a press release.

Cepheid Receives Emergency Use Authorization from FDA for Rapid SARS-CoV-2 Test: First Rapid, Point-of-Care and Near-Patient Molecular Test for Detection of Virus that Causes COVID-19 https://t.co/w0NJxcvSv5

— Cepheid (@CepheidNews) March 21, 2020

The company currently has some 5,000 systems in the US available for point-of-care testing and for use in hospitals, Cepheid President Warren Kocmond was quoted as saying in the press release. These systems do not require users to have specialty training to perform testing, Cepheid said.

According to the text, tests will begin shipping next week.

As of 21 March, the coronavirus infection toll in the US stands at more than 15,000 cases with 201 fatalities, data from the US Centres for Disease Control and Prevention shows.