Monkeypox: Roche bags USFDA EUA for RT-PCR test cobas MPXV
The high-throughput solution can help individuals get the right results quickly.;
Basel: Roche announced today that the U.S. Food and Drug Administration (USFDA) has granted Emergency Use Authorization (EUA) for cobas MPXV for use on the cobas 6800/8800 Systems. The test is a real-time PCR test for the qualitative detection of DNA from the monkeypox virus (MPXV) in lesion swabs collected from individuals suspected of monkeypox infection by their healthcare provider.
cobas MPXV targets two different regions of the MPXV genome, which are both less prone to mutations than other parts of the genome. This dual-target approach ensures that cobas MPXV will continue to detect the virus even if a mutation occurs in one of the target regions.
"When multiple clusters of monkeypox virus infection were initially reported in countries where the disease is not endemic, Roche was among the first companies to address virus concerns with test kits," said Thomas Schinecker, CEO of Roche Diagnostics. "In order to meet the testing needs and workflow demands of laboratories as well as expand access to safe and reliable diagnostic solutions, we developed the cobas MPXV on the fully automated and high-throughput cobas 6800/8800 system."
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