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March 21, 2020

Cepheid, a diagnostics company based in Northern California, announced Saturday that the Food and Drug Administration has approved a test that can deliver COVID-19 results in under an hour, the company said. Current coronavirus test results can take days.

The FDA said the company intends to roll out the test by March 30.

The FDA granted Cepheid Emergency Use Authorization for Xpert® Xpress SARS-CoV-2, “a rapid molecular diagnostic test for qualitative detection of SARS-CoV-2, the virus causing COVID-19,” the company said in a press release Saturday.
According to Cepheid, the test has a “detection time of approximately 45 minutes.”

“During this time of increased demand for hospital services… 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,” said Dr. David Persing, Chief Medical and Technology Officer at Cepheid, in the press release.

“We have developed a test that provides reference lab-quality results in multiple settings where actionable treatment information is needed quickly.”

According to the company, the test will begin shipping “next week” and can be used on their more than 23,000 systems worldwide, nearly 5,000 of which are located in the United States.

“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,” said Cepheid president Warren Kocmond.