FDA Approves Rapid Diagnostic Test for COVID-19

FDA Approves Rapid Diagnostic Test for COVID-19

VOICE News Staff

A California company, Cepheid, was just approved to produce the nation’s first rapid, point-of-care diagnostic test for COVID-19.

The test will enable doctors to test a sample for COVID -19 and get results in about 45 minutes. According to the company its testing process is designed to run on the developer’s automated GeneXpert hardware which has no less than 23,000 tabletop systems installed worldwide and with no less than 5,000 in the U.S.

David Persing, Cepheid’s chief medical and technology officer, commented in a press release, “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 healthcare facilities.”

He continued, “An accurate test delivered close to the patient can be transformative—and help alleviate the pressure that the emergence of the COVID-19 outbreak has put on healthcare facilities that need to properly allocate their respiratory isolation resources.”

Now that the company has successfully secured the Federal Drug Administration’s emergency use authorization, it says it is ready to begin shipping the test this week.

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