Roche’s COVID-19 PCR Test Portfolio Gets CE Mark to Run on Cobas 5800 System

Roche has received a CE mark to offer its COVID-19 polymerase chain-reaction (PCR) test portfolio for use on its recently launched cobas 5800 molecular laboratory instrument.

The tests covered by the new certification include cobas SARS-CoV-2 Qualitative and cobas SARS-CoV-2 & Influenza A/B.  Roche says it is pursuing CE marks for more tests for use on the cobas 5800 system through mid-2022.

The company said it expects to gain FDA’s approval for the cobas 5800 system in the third quarter of this year.