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US backs Roche s virus-flu differentiation test

September 4, 2020 07:15 PM


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Swiss pharmaceuticals giant Roche said Friday it had received the green light in the United States for emergency use of a diagnostic test differentiating between coronavirus and influenza.

Amid fears the flu season will place additional burdens on health system, authorities are keen to see tests which can distinguish coronavirus from other seasonal illnesses, notably flu.   

Roche said its cobas SARS-CoV-2 & Influenza A/B test had won Emergency Use Authorization approval from the US Food and Drug Administration (FDA).

The firm added the test would also be available for use in countries where the European CE certification mark applies. 

"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 Thomas Schinecker, CEO of Roche Diagnostics.

"Now, with a single test, healthcare professionals can confidently provide the right diagnosis and most effective treatment plan for their patients."

The test uses nasal or nasopharyngeal swab samples taken from people suspected of having a respiratory infection and will be used on fully automated cobas 6800 and 8800 diagnostic machines which are common in hospitals and which can carry out out large-volume testing.

Roche said for this test the machines can provide up to 96 results in roughly three hours to offer "the fastest time to results with the highest throughput" for testing of SARS-CoV-2 (coronavirus) and Influenza A/B strands.

The tests come as companies race to find a vaccine to a disease which has killed more than 860,000 people globally since the outbreak emerged late last year in China with more than 26 million cases registered.



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