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Roche responds to WHO’s declaration of a global health emergency due to the ongoing mpox outbreak

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Roche has announced its support for the global response to the mpox outbreak, declared a Public Health Emergency of International Concern by the WHO on August 14, 2024. The company is providing high-quality PCR testing and working to enhance laboratory capacity worldwide. Roche has developed three LightMix® Modular Virus kits and the cobas® MPXV test to detect the mpox virus, confirming that these tests can identify the latest variants.

Matt Sause, CEO of Roche Diagnostics, emphasized the importance of diagnostics in addressing public health challenges like mpox. Roche is partnering with governments, healthcare providers, and organizations to combat the outbreak, and is providing training for laboratories across Africa at the Roche Scientific Campus in South Africa and locally.

Roche ha annunciato il suo supporto alla risposta globale all'epidemia di mpox, dichiarata Emergenza Sanitaria Pubblica di Interesse Globale dall'OMS il 14 agosto 2024. L'azienda sta fornendo test PCR di alta qualità e lavorando per migliorare la capacità di laboratorio in tutto il mondo. Roche ha sviluppato tre kit LightMix® Modular Virus e il test cobas® MPXV per rilevare il virus mpox, confermando che questi test possono identificare le ultime varianti.

Matt Sause, CEO di Roche Diagnostics, ha sottolineato l'importanza della diagnostica nell'affrontare le sfide sanitarie pubbliche come l'mpox. Roche sta collaborando con governi, fornitori di servizi sanitari e organizzazioni per combattere l'epidemia, e sta fornendo formazione per i laboratori in tutta l'Africa presso il Roche Scientific Campus in Sudafrica e a livello locale.

Roche ha anunciado su apoyo a la respuesta global ante el brote de mpox, declarado Emergencia de Salud Pública de Preocupación Internacional por la OMS el 14 de agosto de 2024. La compañía está proporcionando pruebas PCR de alta calidad y trabajando para mejorar la capacidad de los laboratorios en todo el mundo. Roche ha desarrollado tres kits LightMix® Modular Virus y la prueba cobas® MPXV para detectar el virus mpox, confirmando que estas pruebas pueden identificar las últimas variantes.

Matt Sause, CEO de Roche Diagnostics, enfatizó la importancia de la diagnóstico para abordar retos de salud pública como el mpox. Roche está colaborando con gobiernos, proveedores de atención médica y organizaciones para combatir el brote, y está proporcionando capacitación para los laboratorios en toda África en el Roche Scientific Campus en Sudáfrica y localmente.

로슈는 2024년 8월 14일 WHO에 의해 국제적으로 우려되는 공중 보건 비상 사태로 선언된 mpox 발병에 대한 글로벌 대응을 지원한다고 발표했습니다. 이 회사는 고품질 PCR 테스트를 제공하고 전 세계적으로 실험실 용량을 향상시키기 위해 노력하고 있습니다. 로슈는 mpox 바이러스를 감지하기 위해 세 가지 LightMix® Modular Virus 키트cobas® MPXV 테스트를 개발하였으며, 이러한 테스트가 최신 변종을 식별할 수 있다는 것을 확인했습니다.

로슈 진단의 CEO인 맷 소스는 mpox와 같은 공중 보건 문제를 해결하는 데 있어 진단의 중요성을 강조했습니다. 로슈는 정부, 의료 제공자 및 조직과 협력하여 발병을 퇴치하고 있으며, 남아프리카의 로슈 과학 캠퍼스와 현지에서 아프리카 전역의 실험실 훈련을 제공하고 있습니다.

Roche a annoncé son soutien à la réponse mondiale à l'épidémie de mpox, déclarée État d'Urgence Sanitaire Publique de portée Internationale par l'OMS le 14 août 2024. L'entreprise fournit des tests PCR de haute qualité et s'efforce d'améliorer la capacité des laboratoires à l'échelle mondiale. Roche a développé trois kits LightMix® Modular Virus et le test cobas® MPXV pour détecter le virus mpox, confirmant que ces tests peuvent identifier les dernières variantes.

Matt Sause, PDG de Roche Diagnostics, a souligné l'importance du diagnostic dans la lutte contre les défis de santé publique tels que le mpox. Roche s'associe à des gouvernements, des fournisseurs de soins de santé et des organisations pour lutter contre l'épidémie et propose une formation pour les laboratoires à travers l'Afrique au Roche Scientific Campus en Afrique du Sud et localement.

Roche hat seine Unterstützung für die globale Reaktion auf den mpox-Ausbruch bekannt gegeben, der am 14. August 2024 von der WHO als Öffentliches Gesundheitsnotfall von internationaler Tragweite erklärt wurde. Das Unternehmen bietet hochwertige PCR-Tests an und arbeitet daran, die Laborkapazitäten weltweit zu verbessern. Roche hat drei LightMix® Modular Virus-Kits und den cobas® MPXV-Test zur Erkennung des mpox-Virus entwickelt und bestätigt, dass diese Tests die neuesten Varianten identifizieren können.

Matt Sause, CEO von Roche Diagnostics, betonte die Bedeutung der Diagnostik bei der Bewältigung von Herausforderungen im Bereich der öffentlichen Gesundheit wie mpox. Roche arbeitet mit Regierungen, Gesundheitsdienstleistern und Organisationen zusammen, um dem Ausbruch entgegenzuwirken, und bietet Schulungen für Labore in ganz Afrika am Roche Scientific Campus in Südafrika und vor Ort an.

Positive
  • Developed multiple diagnostic tests for mpox virus detection
  • Actively enhancing global laboratory testing capacity for mpox
  • Partnering with governments and healthcare providers to combat the outbreak
  • Providing training for laboratories across Africa
Negative
  • None.
  • Roche is committed to supporting all those working to overcome the mpox outbreak by providing access to high-quality Polymerase Chain Reaction (PCR) testing
  • Roche confirms that its cobas MPXV test, as well as the LightMix® research use only kits, detect the latest mpox virus variants
  • It is actively working to enhance laboratory testing capacity for mpox worldwide

Basel, 20 August 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today 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 declared a Public Health Emergency of International Concern by the World Health Organization (WHO) (14 August 2024).

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 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.

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.

About the virus
MPXV was first detected in laboratory monkeys in 1958. The virus is, however, assumed to be transmitted from wild animals such as rodents to people — or from human to human. Symptoms of mpox include fever, chills, headaches, muscle aches, fatigue, swollen lymph nodes and a painful rash that characteristically appears as raised bumps on the skin and tends to be distributed on the face, extremities and genitals. As the disease progresses, these bumps fill with pus and fluid and become umbilicated. They will eventually ulcerate, scab and fall off. 1

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the fifteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

* 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.

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Hans Trees, PhD
Phone: +41 79 407 72 58
Sileia Urech
Phone: +41 79 935 81 48
Nathalie Altermatt
Phone: +41 79 771 05 25
Lorena Corfas
Phone: +34 620 29 25 51
Simon Goldsborough
Phone: +44 797 32 72 915
Karsten Kleine
Phone: +41 79 461 86 83
Nina Mählitz
Phone: +41 79 327 54 74
Kirti Pandey
Phone: +49 172 6367262
Yvette Petillon
Phone: +41 79 961 92 50
Dr. Rebekka Schnell
Phone: +41 79 205 27 03

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FAQ

What diagnostic tests has Roche developed for mpox (RHHBY)?

Roche has developed three LightMix® Modular Virus kits for use on LightCycler®480 II Instrument, LightCycler® PRO or cobas® z 480 Analyzer, and the cobas® MPXV test for use on the cobas® 6800/8800 Systems.

When did the WHO declare mpox a global health emergency, and how is Roche (RHHBY) responding?

The WHO declared mpox a Public Health Emergency of International Concern on August 14, 2024. Roche is responding by providing high-quality PCR testing, enhancing global laboratory capacity, and partnering with governments and healthcare providers to combat the outbreak.

How is Roche (RHHBY) supporting laboratory capacity for mpox testing in Africa?

Roche is providing training for laboratories across the African continent at the Roche Scientific Campus in South Africa, as well as locally, to enhance mpox laboratory capacity.

Can Roche's (RHHBY) tests detect the latest mpox virus variants?

Yes, Roche has confirmed that its cobas MPXV test and the LightMix® research use only kits can detect the latest mpox virus variants.

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