On Nov. 15, 2022, Roche announced that the U.S. Food and Drug Administration (FDA) had granted Emergency Use Authorization 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 mpox virus (MPXV) in lesion swabs collected from individuals suspected of mpox 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.

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.

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.

cobas® MPXV is intended for use for the qualitative detection of DNA from monkeypox virus in individuals suspected of monkeypox infection by their healthcare provider. cobas MPXV for use on cobas 6800/8800 Systems is the first monkeypox virus test granted EUA following evaluation in actual patient samples rather than just samples formulated in the laboratory. The assay uses β-globin, a target present in human DNA, as an endogenous control to ensure specimen adequacy. Unlike the previously cleared assay, cobas MPXV detects monkeypox nucleic acids and the endogenous control in the same well, improving laboratory efficiency by effectively doubling the number of clinical samples a laboratory can assess on each plate and halving reagent needs per sample.