Danaher's Cepheid Receives FDA Emergency Use Authorization For 45-Minute Coronavirus Test

Late Friday night, the U.S. Food And Drug Administration approved the first coronavirus test that can be conducted entirely at the point of care for a patient and deliver results in 45 minutes.

Cepheid's Xpert Xpress SARS-CoV-2 is a rapid molecular diagnostic test for qualitative detection of SARS-CoV-2, the virus causing COVID-19, the company said in a press release. The test has been designed to operate on any of Cepheid's more than 23,000 automated GeneXpert Systems worldwide.

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At time of publication Sunday, the U.S. has a total of 26,747 confirmed COVID-19 cases, according Johns Hopkins University.

"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.

Cepheid is a molecular diagnostics company and a subsidiary within Danaher Corporation's DHR Diagnostics platform. The company develops, manufactures and markets easy-to-use molecular systems and tests.

Danaher's stock closed Friday's session at $123.81 per share.

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