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Roche Obtains CE Mark for Three Tests on New Cobas PCR Instrument

NEW YORK – Roche announced on Tuesday that it is launching three new tests on its molecular Cobas 5800 instrument in countries accepting the CE mark.

The RT-PCR tests for BK virus, cytomegalovirus, and Epstein-Barr virus received CE marking for use on the Cobas 5800 system in the last couple of weeks, a Roche spokesperson said via email. The tests are intended for use in transplant patients at risk of infection and can run simultaneously on the Cobas 5800.

Roche's Cobas BKV test received 510(k) clearance from the US Food and Drug Administration for use with its high-throughput Cobas 6800 and 8800 systems in 2020. The CMV test garnered FDA approval for the systems in 2017, and the Epstein-Barr virus test was cleared by the agency in 2020.

The existing test menu on the Cobas 5800 includes assays for hepatitis B, hepatitis C, HIV, and SARS-CoV-2, as well as multiplex tests for SARS-CoV-2 and influenza A/B, chlamydia and gonorrhea, and Trichomonas vaginalis and Mycoplasma genitalium.

The Cobas 5800 instrument, which delivers up to 144 results in an eight-hour shift, received CE marking last November.