Roche has said that it is supporting the international response to the mpox global health emergency with its diagnostic tests developed for mpox, formerly known as monkeypox.
Mpox, a viral disease that can spread easily between people and from infected animals, was recently declared a Public Health Emergency of International Concern by the World Health Organization.
Globally, Roche is partnering with governments, healthcare providers and organisations dedicated to combating the mpox outbreak. More specifically, Roche is actively working with its partners to enhance mpox laboratory capacity worldwide. In addition, Roche provides training for laboratories across the African continent at the Roche Scientific Campus in South Africa, as well as locally.
“Our commitment to support the global response to mpox began in 2022 when we developed a suite of tests to enable global access to rapid and high-quality PCR testing,” said Matt Sause, CEO of Roche Diagnostics. “Diagnostics are essential in addressing emerging public health challenges like mpox, as they enable healthcare providers to identify infected patients, devise effective treatment strategies and take appropriate actions.”
To detect the mpox virus, Roche developed three unique LightMix Modular Virus kits for use on either a LightCycler480 II instrument*, LightCycler PRO or cobas z 480 analyser, as well as the cobas MPXV test for use on the cobas 6800/8800 systems.
In May 2022, Roche and its subsidiary TIB Molbiol rapidly developed a new suite of tests that detect the virus that causes mpox and aid in following its epidemiologic spread. The LightMix Modular Orthopox / Monkeypox Virus Kits are assays that detect orthopoxviruses, including the virus that causes mpox, using quantitative PCR (qPCR). To do this, the test is performed with a patient sample that is first extracted using an established nucleic acid (NA) extraction method. The assay is then performed on either a LightCycler 480 II instrument, LightCycler PRO or cobas z 480 analyser.
The LightMix Modular Orthopox / Monkeypox Virus kits are intended for use in confirmatory testing (evaluation and validation) in public health labs as Research Use Only, and are designed for research use in the majority of countries worldwide.
In November 2022, the FDA granted Roche Emergency Use authorisation (EUA) for the cobas MPXV test for use on the high-throughput cobas 6800/8800 systems. The cobas MPXV test is an automated, real-time PCR test for the qualitative detection of DNA from the virus (MPXV) that causes mpox in human lesion swabs collected from individuals suspected of mpox infection by their healthcare provider and uses a dual-target approach. This approach ensures that cobas MPXV will continue to detect the virus even if a mutation occurs in one target region.