Roche launches cobas 5800 molecular analyzer in Europe, anticipates FDA approval

Nov. 18, 2021

Roche has launched the cobas 5800 System, a new molecular laboratory instrument, in countries accepting the CE mark, and Roche said it anticipates receiving U.S. Food and Drug Administration (FDA) approval for the product during the third quarter of 2022.

“We are pleased that we can now offer a compact, fully-automated molecular system such as the cobas 5800 System. 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,” said Thomas Schinecker, CEO at Roche Diagnostics.

The cobas 5800 System is a real-time PCR molecular testing solution.The system is built to offer a fully automated workflow that encompasses sample supply, transfer and preparation, amplification and detection, result calculation and delivery to the laboratory information system (LIS). The single module enables a walkaway time of up to eight hours.

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