21 March 2020. (Reuters) – 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.
The FDA confirmed its approval in a separate statement. It said the company intends to roll out the availability of its testing by March 30.
Under the current testing regime, samples must be sent to a centralized lab, where results can take days.
“With new tools like point-of-care diagnostics, we are moving into a new phase of testing, where tests will be much more easily accessible to Americans who need them,” U.S. Secretary of Health and Human Services Alex Azar said on Saturday.
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.
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 give further details or 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.