Roche gets approval for coronavirus and flu tests
Swiss pharma giant Roche says it has received Emergency Use Authorization from the United States for a test to quickly detect whether a patient has Covid-19 or one of two forms of influenza.
The company said in a statement on FridayExternal link that it had received the go-ahead from the US Food and Drug Administration for the test be used in certain approved laboratories for the duration of the declaration. It will also be available in markets accepting the CE mark, Roche said.
The test is intended for the simultaneous detection and differentiation of SARS-CoV-2, Influenza A and Influenza B in patients suspected of having respiratory viral infection consistent with Covid-19, Roche said.
“With the approaching flu season, this new test is particularly important as SARS-CoV-2 and influenza infections can hardly be differentiated by symptoms alone,” said Roche diagnostics head Thomas Schinecker. “Now, with a single test, healthcare professionals can confidently provide the right diagnosis and most effective treatment plan for their patients.”
The test will be for use on Roche’s Cobas 6800/8800 systems, which are capable of handling large volumes and are often found in hospitals. They can perform 96 tests within three hours, the company said.
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