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New Roche Cobas System Nabs CE Mark

NEW YORK – Roche announced on Thursday that its new Cobas 5800 molecular instrument has received CE marking.

The platform builds on Roche's Cobas menu, which includes its Cobas 6800 and 8800 instruments, and provides a more compact module with a fully automated workflow.

The real-time PCR-based instrument delivers up to 144 results in an eight-hour shift and offers a workflow that includes sample supply, transfer and preparation, amplification and detection, result calculation, and delivery to the laboratory information system, Roche said in a statement.

The Cobas 5800 will offer the same test menu as the 6800 and 8800 systems, including the Cobas SARS-CoV-2 test, Roche added. Other tests on Roche's Cobas menu are its BK polyomavirus assay, HIV-1/HIV-2 Qualitative test, and Epstein-Barr virus test.

"This new system helps to address the high demands on labs through greater efficiency, optimized workflows and cost savings, enabling them to deliver quality patient care," Roche Diagnostics CEO Thomas Schinecker said in a statement.

The Basel, Switzerland-based company said it anticipates receiving US Food and Drug Administration approval for the platform during the third quarter of 2022.