TIB MOLBIOL Syntheselabor GmbH

Roche is committed to supporting all those working to overcome the mpox outbreak by providing access to high-quality Polymerase Chain Reaction (PCR) testingRoche 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 KitsIn 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 testIn 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 virusMPXV 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 RelationsPhone: +41 61 688 8888 / e-mail: media.relations@roche.com Hans Trees, PhDPhone: +41 79 407 72 58Sileia UrechPhone: +41 79 935 81 48Nathalie AltermattPhone: +41 79 771 05 25Lorena CorfasPhone: +34 620 29 25 51Simon GoldsboroughPhone: +44 797 32 72 915Karsten KleinePhone: +41 79 461 86 83Nina MählitzPhone: +41 79 327 54 74Kirti PandeyPhone: +49 172 6367262Yvette PetillonPhone: +41 79 961 92 50Dr. Rebekka SchnellPhone: +41 79 205 27 03 Attachment 20082024_Mpox_EN

The Swiss biopharmaceutical group has acquired the Berlin-based diagnostics biotech after two decades of collaboration, expanding its PCR test portfolio. There was a time when few non-scientists had heard of PCR (polymerase chain reaction) tests but now, in the age of COVID-19, the term has entered everyday language. As another sign of its importance, Roche has acquired its long-term partner, diagnostics company TIB Molbiol in order to expand its test portfolio and bolster ‘the fight against new infectious diseases’. Roche announced its intention to acquire the company in September and has now completed its share purchase agreement, acquiring all of TIB Molbiol Group’s outstanding shares. The company will operate under the Roche umbrella as a subsidiary of the Diagnostics division, adding its 45+ CE-marked in vitro diagnostics assays and 100+ research-use assays to the Roche portfolio. The two companies have collaborated for more than 20 years ‘to rapidly address critical healthcare needs including biological threats’ that include SARS, anthrax, avian influenza virus H5N1, MERS, the novel influenza virus H1N1 swine, Ebola virus, Zika virus and most recently, SARS-CoV-2 virus and its variants, said Roche. “I am very pleased that together with TIB Molbiol, we can significantly improve access for patients to a broader spectrum of diagnostic tests – from high volume routine tests to the diagnosis of rare diseases,” said Thomas Schinecker, head of Roche Diagnostics. “TIB Molbiol will continue to be an innovation engine and frontrunner in our common fight against infectious diseases, such as SARS-CoV-2.” For more than 30 years TIB Molbiol has supplied reagents for research and medical diagnostics including custom oligonucleotides with which the company partnered in the development of molecular diagnostics. The resulting broad portfolio of diagnostic assays covers inherited genetic as well as somatic mutation testing, quantitative assays for haematology and transplantation medicine. However, the company’s greatest focus has been on assays to test for infectious diseases. Its assays are available as modular kits that allow ‘symptomatic panels’ to be created by combining assays, which is especially valuable when faced with emerging pathogens. TIB Molbiol’s ultra-rapid assay development for emerging infectious diseases has been demonstrated against both SARS-CoV-1 – when it developed an assay within days in 2003 – and SARS-CoV-2.

Roche signs a definitive share purchase agreement with TIB Molbiol Group to expand PCR-test portfolio against infectious diseases. Roche has announced that it has signed a definitive share purchase agreement to acquire 100 percent of the outstanding shares of the TIB Molbiol Group. Closing of the transaction is subject to customary conditions and is expected in the fourth quarter of 2021. According to Roche, the acquisition will enhance its broad portfolio of molecular diagnostics solutions with a wide range of assays for infectious diseases, such as the identification of SARS-CoV-2 variants. TIB Molbiol’s portfolio of over 45 CE- in vitro diagnostic (IVD) assays and >100 research use assays are already available on Roche’s large installed base of LightCycler PCR systems and MagNA Pure sample preparation systems. TIB Molbiol is a manufacturer of custom oligonucleotides and has partnered in the development of molecular diagnostics and built a broad portfolio of diagnostic assays, in particular for inherited genetic as well as somatic mutation testing, quantitative assays for haematology and transplantation medicine. The majority of these assays are used to test for infectious diseases and are available as modular kits, enabling the creation of symptomatic panels by combining assays, including emerging pathogens. The two companies have collaborated for more than 20 years to address critical healthcare needs, such as Severe Acute Respiratory Syndrome (SARS), anthrax, avian influenza virus (H5N1), Middle East Respiratory Syndrome (MERS), the novel influenza virus (H1N1) swine, Ebola virus, Zika virus and most recently, the SARS-CoV-2 virus and its variants. “With this acquisition, we can expand our offering of tests of existing pathogens and our response to emerging pathogens and potential health threats,” Thomas Schinecker, CEO Roche Diagnostics, stated. “At the onset of the COVID-19 pandemic, our collaboration provided the first research-use-only SARS-CoV-2 detection test that was provided in January 2020, only days after the new coronavirus was first sequenced. Together, we can further improve patient outcomes with innovative diagnostic solutions that alleviate healthcare costs.”