FDA approves first rapid coronavirus test with 45 minutes detection time


The U.S. Food and Drug Administration has approved the first rapid coronavirus diagnostic test, with a detection time of about 45 minutes, the test’s developer, California-based molecular diagnostics company Cepheid, said on Saturday.

Cepheid said in a statement it had received an emergency use authorization from the FDA for the test, which will be used primarily in hospitals and emergency rooms. The company plans to begin shipping it to hospitals next week, it said.

Under the current testing regime, samples must be sent to a centralized lab, where results can take days.

The diagnostic test for the virus that causes COVID-19 has been designed to operate on any of Cepheid’s more than 23,000 automated GeneXpert Systems globally, the company said, without giving details.

The systems do not require users to have specialty training to perform testing, and are capable of running around the clock, Cepheid President Warren Kocmond said in the statement.

The company did not say how much the test will cost.

The U.S. FDA has been pushing to expand screening capacity for the virus while the World Health Organization has called for “order and discipline” in the market for health equipment needed to fight the outbreak.

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