Roche (SIX: RO, ROG; OTCQX: RHHBY) announced its commitment to supporting the global response to the mpox health emergency by providing diagnostic tests specifically developed for mpox, formerly known as monkeypox. The World Health Organization (WHO) declared mpox a Public Health Emergency of International Concern on August 14, 2024, due to its potential to spread rapidly between people and from infected animals.
Roche is collaborating with governments, healthcare providers, and organizations worldwide to combat the mpox outbreak. The company is focused on enhancing laboratory capacity for mpox testing globally and is providing specialized training for laboratories, particularly across the African continent through the Roche Scientific Campus in South Africa.
Roche has confirmed that its cobas MPXV test, along with the LightMix® research-use-only kits, effectively detects the latest mpox virus variants. The company is actively working to expand testing capacity for mpox worldwide.
“Our commitment to supporting the global response to mpox began in 2022 when we developed a suite of tests to enable rapid and high-quality PCR testing,” said Matt Sause, CEO of Roche Diagnostics. “Diagnostics play a critical role in addressing public health challenges like mpox by allowing healthcare providers to identify infected patients, develop effective treatment strategies, and take appropriate actions.”
To detect the mpox virus, Roche developed three specialized LightMix® Modular Virus kits* for use with the LightCycler® 480 II Instrument*, LightCycler® PRO, or cobas® z 480 Analyzer, as well as the cobas® MPXV test designed for use on the cobas® 6800/8800 Systems.
About the LightMix Modular Orthopox / MonkeypoxVirus Kits
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 a technology called 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 Analyzer.
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.
About the cobas MPXV test
In November 2022, the FDA granted Roche Emergency Use authorization (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.
