Roche obtains FDA authorization for monkeypox test on high-throughput MDx system

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Roche said Wednesday it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Cobas MPXV test on its high-throughput Cobas 6800/8800 systems.

The real-time polymerase chain reaction (PCR) test for the qualitative detection of DNA from monkeypox virus (MPXV) in lesion swabs is collected from individuals suspected of monkeypox infection by their healthcare provider.

The Cobas MPXV test targets two different regions of the MPXV genome which are both less prone to mutations than other parts of the genome, Roche said, adding that the dual-target approach ensures that Cobas MPXV will continue to detect the virus even if a mutation occurs in one of the target regions.

Like many viruses, monkeypox cannot be conclusively diagnosed by symptoms alone. This is because many monkeypox symptoms closely resemble those of other rash-producing illnesses such as chickenpox, measles, bacterial skin infections, and even hives or allergies.

"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," Thomas Schinecker, CEO of Roche Diagnostics, said in a statement.

The high-throughput solution can help individuals get the right results quickly. This is important so that patients are not subjected to unnecessary additional testing or isolation and will have access to appropriate treatment as soon as possible, Roche noted. 

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