Roche receives FDA Emergency Use Authorization for the cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas 6800/8800 Systems

Basel, 04 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the cobas ® SARS-CoV-2&Influenza A/B Test for use on the cobas ® 6800/8800 Systems has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). This test is intended for the simultaneous qualitative detection and differentiation of SARS-CoV-2, Influenza A and Influenza B in patients suspected by their healthcare provider of having respiratory viral infection consistent with COVID-19. Additionally, it is available in markets accepting the CE mark.“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. Now, with a single test, healthcare professionals can confidently provide the right diagnosis and most effective treatment plan for their patients,” said Thomas Schinecker, CEO of Roche Diagnostics. “As a leader in diagnostics testing solutions, this launch demonstrates our ongoing commitment to stop the spread of serious infectious diseases by increasing access to accurate, reliable and efficient testing options.” Roche ’s widely-available, fully-automated cobas 6800/8800 Systems, which are used to perform the SARS-CoV-2&Influenza A/B Test, offer the fastest time to results with the highest throughput and the longest walk-away time available among automated molecular platforms. The systems provide up to 96 results...
Source: Roche Media News - Category: Pharmaceuticals Source Type: news

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