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Roche obtains FDA EUA for monkeypox virus detection test

November 17, 2022

Roche has received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its monkeypox virus detection test, cobas MPXV, for use on the cobas 6800/8800 Systems.

The real-time PCR test has been designed for detecting DNA from the monkeypox virus (MPXV) in lesion samples collected from individuals who are suspected of infection.

It targets two different areas of the MPXV genome, which are less prone to mutations compared to other parts of the genome.

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