Novacyt, a healthcare company specializing in clinical diagnostics, announced on Monday approval from the U.S. Food & Drug Administration (FDA) regulator for its product aimed at testing for coronavirus.
Novacyt said the FDA's approval meant that hospitals and laboratories in the United States would be able to use the test for clinical diagnosis of the coronavirus, and that the test was now available for immediate distribution in the U.S. market.
"The U.S. FDA EUA authorization is another important endorsement of the performance and quality of our COVID-19 test and demonstrates once again Novacyt's growing role in tackling this pandemic," said Novacyt CEO Graham Mullis.
(Reporting by Sudip Kar-Gupta, editing by Louise Heavens)
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