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Roche Gets CE Mark for SARS-CoV-2, Influenza Tests on New Cobas Molecular System

NEW YORK – Roche announced on Wednesday that it received CE marking for two of its SARS-CoV-2 tests to run on the firm's new Cobas 5800 system. 

The firm launched its Cobas SARS-CoV-2 Qualitative and Cobas SARS-CoV-2 & Influenza A/B tests for the PCR-based instrument in countries accepting the CE mark in early February, a company spokesperson said via email. Roche's Cobas SARS-CoV-2 Qualitative test received Emergency Use Authorization from the US Food and Drug Administration in March 2020, while its combo SARS-CoV-2 and influenza A/B test nabbed EUA in September 2020.

The Cobas 5800 instrument, a low-volume version of the Cobas 6800 and 8800 systems, received CE marking in November. It provides a more compact module with a fully automated workflow and can return up to 144 results in an eight-hour period.

The Cobas 5800 will offer the same menu as the Cobas 6800/8800 instruments, and Roche is pursuing additional CE marking for continued menu expansion, the firm said in a statement. It anticipates tests launching beyond CE markets this year, Roche added.

In December, four of Roche's molecular infectious disease tests nabbed CE marking for use with the instrument: its Cobas HIV-1, hepatitis B, hepatitis C, and HIV-1/HIV-2 qualitative tests. The Cobas Omni Utility Channel kit, which consolidates open channel tests and Roche in vitro diagnostic tests onto a single platform, received CE marking at the same time.