The U.S. Food and Drug Administration has approved a rapid molecular diagnostic test its maker says can detect the Coronavirus strain COVID-19 in about 45 minutes.
California-based Cepheid Saturday said it received an “emergency use authorization” from the FDA for its XpertXpress SARS-CoV-2 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,” the company said in its announcement.
The FDA’s approval is the latest in a parade of the agency’s emergency use authorizations for diagnostic tests for Coronavirus following weeks of criticism of the Trump administration and federal agencies for the lack of testing for Coronavirus. The U.S. is considered well behind other countries when it comes to the availability of testing generally.
“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,” Cepheid chief medical and technology officer Dr. David Persing said Saturday.
It’s the kind of test that will work will on the frontlines for healthcare workers and in physician offices. Many of the Coronavirus tests recently approved are used in large hospitals and academic medical centers.
Just this week, former FDA Commissioner Dr. Scott Gottlieb mentioned the Cepheid “point of care” technology as something that was needed in the field.
“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,” Persing said. “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.”