FDA approves first rapid coronavirus test with 45 minutes detection time


Reporting by Kanishka Singh in Bengaluru; Editing by Sonya Hepinstall, Reuters†

March 21, 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 testís 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 Cepheidís more than 23,000 automated GeneXpert Systems globally, the company said, without giving details.


The systems do not require...