Summary: Roche has announced its continued support in addressing the global mpox emergency by partnering with healthcare providers and organizations to enhance diagnostic testing and laboratory capacity worldwide.

Takeaways:

  1. Global Collaboration: Roche is partnering with governments, healthcare providers, and organizations to strengthen the global response to the mpox outbreak, emphasizing collaboration and resource sharing.
  2. Advanced Diagnostic Tools: Roche has developed specialized LightMix Modular Virus kits and the cobas MPXV test, which utilize PCR technology to detect the mpox virus, ensuring high accuracy and reliability even with potential viral mutations.
  3. Focus on Africa: Roche is providing laboratory training and support across the African continent, aiming to enhance local capacity for detecting and managing mpox through initiatives at the Roche Scientific Campus in South Africa.

Roche is supporting the international response to the mpox global health emergency with its diagnostic tests developed for mpox, formerly known as monkeypox, the company announced

Addressing the Mpox Emergency

Mpox, a viral disease that can spread easily between people and from infected animals, was declared a Public Health Emergency of International Concern by the World Health Organization (WHO).

Globally, Roche is partnering with governments, healthcare providers and organizations 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,” says 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.”

Detecting the Mpox Virus

To detect the mpox virus, Roche developed three unique LightMix Modular Virus kits* for use on either a LightCycler 480 II Instrument*, LightCycler PRO or cobas z 480 Analyzer, as well as the cobas MPXV test for use on the cobas 6800/8800 Systems.

LightMix Modular Orthopox and 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.

Further reading: Self-Sampling Proves Effective for Asymptomatic Mpox Diagnosis

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.

* These products are for Research Use Only. Not for use in diagnostic procedures.

References:

  1. World Health Organization factsheet monkeypox. Available at: https://www.who.int/news-room/fact-sheets/detail/monkeypox. Accessed 15 August 2024.