• New Roche test targeting detection of Bundibugyo virus supports efforts to address critical need during ongoing outbreaks¹
• Roche's unique outbreak response capabilities enabled rapid development of the PCR test within six days of the Bundibugyo genome sequence being published
• This assay enables laboratories to swiftly establish testing capabilities, helping to contain the outbreaks while providing critical surveillance to monitor any further spread

BERLIN, June 4, 2026 /PRNewswire/ -- Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that it developed a Research Use Only (RUO) molecular PCR test, via its subsidiary TIB MOLBIOL, for use on the LightCycler® 480 I & II Systems, LightCycler® PRO System and the cobas® z 480 analyzer to detect the rare Ebola Bundibugyo virus. Developed within just six days as part of its outbreak preparedness and surveillance expertise, this test supports response efforts in Central and East Africa and helps address critical needs identified during the ongoing outbreak. The World Health Organization (WHO) declared the outbreak in the Democratic Republic of Congo (DRC) and Uganda a Public Health Emergency of International Concern on 17 May 2026.

TIB MOLBIOL is dedicated to PCR diagnostics and sits at the frontline of outbreak response, maintaining a "rapid response" library of 15,000 test pre-designs across a wide range of pathogens and more than 3,000 positive control materials. This extensive library and expertise in oligonucleotide synthesis allowed TIB MOLBIOL to evaluate multiple primer and probe combinations for the rare Ebola Bundibugyo virus within hours rather than weeks. The off-the-shelf approach is also supported by the immediate mobilization of TIB MOLBIOL's workforce and facility resources to address outbreaks as soon as they are identified.

"In outbreak situations, we recognize the ability to respond quickly is critical, and diagnostics are among the first vital tools needed," said Dr. Marcus Droege, CEO of TIB MOLBIOL. "Research-use assays play a crucial role in the first phase of the outbreak response, and our focus is on working closely with laboratories to establish testing capability quickly, support surveillance and response efforts, and enable faster, more informed decision-making when it matters most."

Ahead of fully approved diagnostic availability, RUO tests are shipped directly to laboratories where they can be validated, which is essential for early-stage outbreak response, surveillance and research. Validation of a product as an in-vitro diagnostic (IVD) or for emergency use can take months or even years.

Using real clinical samples, the assay's performance and specificity for the Bundibugyo variant were expeditiously evaluated by TIB MOLBIOL's network of independent reference labs, providing critical real-time feedback.

Roche is now working directly with public health laboratories and authorities in affected regions to bring vital PCR testing closer to the Ebola outbreak frontlines to support faster detection in line with WHO guidance² to strengthen laboratory capacity and ensure rapid testing access. As a long-standing partner in healthcare infrastructure across the African continent, Roche's local partnerships and regional supply chains ensure that critical surveillance tools can be effectively made accessible to the reference laboratories and public health institutions that urgently require them during this emergency.

This test for the Bundibugyo virus is the latest in a series of rapid-response molecular solutions for infectious diseases produced at scale by Roche, including Mpox in 2022, Covid-19 in 2020, ZIKA in 2015, Ebola (Zaire species) in 2014/15, MERS in 2012, H1N1 swine flu in 2009, H5N1 bird flu in 2005 and SARS in 2003. Most recently, the team at TIB MOLBIOL also developed and deployed an Andes virus test following the cruise ship outbreak of Hantavirus Disease.

About Ebola
Ebola is a severe and often fatal illness, with average case fatality rates of around 50%, ranging from 25% to 90%³ depending on the outbreak and availability of care. This current outbreak has been particularly challenging because it is caused by the rare Bundibugyo virus⁴, which has historically been associated with fatality rates of approximately 30–50%⁶, and can't be detected by some commonly used frontline tests⁵. This has increased the risk of delayed diagnosis at a critical stage in the response because, with no approved vaccines or specific treatments currently available, delays in detection can contribute to increased transmission and larger outbreaks.

Ebola is caused by viruses that belong to the Orthoebolavirus genus of the filoviridae family⁷. Six species of Orthoebolaviruses have been identified to date, with three known to cause large outbreaks Ebola virus (EBOV) causing Ebola virus disease (EVD), Sudan virus (SUDV) causing Sudan virus disease (SVD), and Bundibugyo virus (BDBV) causing Bundibugyo virus disease (BVD)⁸.

Ebola first occurred in 1976 in two simultaneous outbreaks: one outbreak was of SVD in Nzara in what is now South Sudan and the other was of EVD in Yambuku, in what is now the Democratic Republic of the Congo (DRC), occurring in a village near the Ebola River, from where the disease takes its name¹.

Molecular pathogen detection assays have previously played an important role in Ebola outbreak response. During the 2014–2016 West Africa epidemic, PCR-based technologies, including Roche LightCycler® systems, received Emergency Use Authorisation (EUA) and were used in field laboratories to support faster detection of the virus, helping clinicians confirm infections more quickly and contributing to efforts to limit further spread.

About TIB MOLBIOL
TIB MOLBIOL is a subsidiary of Roche Diagnostics that has supplied the global market with reagents for research and medical diagnostics for over 30 years. As a manufacturer of custom oligonucleotides the company 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 assays are used to test for infectious diseases. They are available as modular kits, enabling the creation of symptomatic panels by combining assays, including emerging pathogens. To support customers performing human genotyping, TIB MOLBIOL provides custom-made LightSNiP assays for SNP analysis. TIB MOLBIOL is headquartered in Berlin (Germany).

For more information about the tests and system, please visit www.diagnostics.roche.com. 

About Roche
Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions.

Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them.

Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market.

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

TIB MOLBIOL Bundibugyo virus test is for research use only. Not for use in diagnostics procedures.

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

References
[1] World Health Organization factsheet: https://www.who.int/news-room/fact-sheets/detail/ebola-disease
[2] Pan American Health Organisation: https://www.paho.org/en/news/18-5-2026-paho-reinforces-preparedness-measures-following-who-ebola-emergency-declaration
[3] World Health Organization factsheet: https://www.who.int/news-room/fact-sheets/detail/ebola-disease
[4] https://www.gavi.org/vaccineswork/bundibugyo-rare-virus-causing-deadly-new-ebola-outbreak-drc-has-no-vaccine-yet;
[5] WHO Disease Outbreak News: https://www.who.int/emergencies/disease-outbreak-news/item/2026-DON602
[6] https://globalnews.ca/news/11855031/ebola-outbreak-explained-who-declares-global-health-emergency/
{7} International Committee on Virus Taxonomy, ICTV : https://ictv.global/report/chapter/filoviridae/filoviridae/orthoebolavirus
[8] International Classification of Disease, ICD-11, 2024: https://icd.who.int/en/

For further information please contact

Irène Stephan, Group Media Relations
Phone: +41 79 377 83 75
e-Mail: irene.stephan@roche.com

Brien Mahoney, Molecular Labs Communications
Phone: +1 925 699 8512
e-Mail: brien.mahoney@roche.com

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SOURCE Roche