Cepheid receives EUA for its SARS-CoV-2 test

March 23, 2020—Cepheid received emergency use authorization from the FDA for its Xpert Xpress SARS-CoV-2, a rapid molecular diagnostic test for the qualitative detection of SARS-CoV-2. The test is for use on the company’s GeneXpert system, with a detection time of about 45 minutes.

“Cepheid currently has nearly 5,000 GeneXpert systems in the U.S. capable of point-of-care testing and for use in hospitals,” Warren Kocmond, president of Cepheid, said in a press release. “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.”