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.
The company stated that this dual-target technique can help in identifying the virus even if a mutation occurs in one of the target regions.
Roche Diagnostics CEO Thomas Schinecker said: “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.
“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.”
The company noted that the high-throughput cobas MPXV test delivers the right results quickly and eliminates the need for unnecessary additional testing or isolation.
It will also facilitate early access to appropriate treatment.
Roche claims that the cobas MPXV for use on cobas 6800/8800 Systems is the first monkeypox virus test to receive FDA EUA after it was assessed in real patient samples rather than samples formulated in a lab.
Last month, the company received FDA 510(k) clearance for its cobas SARS-CoV-2 Qualitative PCR test.