The response to emerging infectious disease outbreaks depends on the rapid deployment of reliable molecular diagnostics, robust laboratory infrastructure and trained local personnel. During the Bundibugyo virus outbreak in the Democratic Republic of the Congo (DRC), Roche and TIB Molbiol collaborated to develop a Research Use Only (RUO) PCR assay within six days of the publication of the virus genome sequence, supporting efforts to strengthen testing capacity for outbreak surveillance and epidemiological research. In this interview with MedTech Spectrum, Marcus Droege, Chief Executive Officer of TIB Molbiol Berlin, discusses the technological and operational considerations involved in developing and deploying molecular diagnostics for emerging pathogens, the challenges of assay validation in resource-constrained settings, and the role of partnerships with public health institutions in expanding regional testing capacity. He also shares insights into how the DRC response could inform future strategies for decentralised molecular testing and infectious disease preparedness.
What were the key technological and operational considerations in selecting the molecular testing platforms for deployment in response to the Bundibugyo virus outbreak?
During an outbreak, laboratories need diagnostic solutions that are accurate, scalable and capable of being implemented quickly within existing workflows so they can be deployed rapidly while maintaining the reliability and quality required for public health decision-making. The selection of molecular testing platforms therefore needs to consider not only analytical performance, but also the practical realities of deployment. Factors such as infrastructure, the availability of technical support, training requirements and local implementation all play an important role. An additional consideration is the choice of diagnostic technology. During the early stages of an outbreak, molecular PCR testing can play a particularly important role because it detects the genetic material of the pathogen directly, allowing laboratories to identify active infections quickly. PCR detects the virus itself, can be developed rapidly from genomic sequence data, and supports early case identification during outbreaks, making it particularly valuable for surveillance and outbreak response. The combination of MagNA Pure and LightCycler systems supports the molecular testing workflow from nucleic acid extraction through to real-time PCR analysis. An important consideration is the ability to leverage established technologies that are already used in laboratories globally, helping to accelerate implementation and training during a time-critical response. Equally important is ensuring the platforms can be deployed in collaboration with local laboratory teams. By working with the Institut National de Santé Publique (INSP) on deployment, training and validation activities, the aim is to help expand testing capacity where needed and as quickly as possible, while supporting sustainable laboratory capability and maintaining the quality standards required for reliable molecular diagnostics during the outbreak response.
What are the key challenges involved in developing a molecular PCR assay for an emerging or less commonly detected pathogen such as the Bundibugyo virus?
Emerging pathogens present unique scientific and operational challenges because information can initially be limited, while the need for testing capability is often urgent. Developing a molecular assay requires both speed and scientific rigour, but assay development is only one part of the process. Testing solutions must also be evaluated, validated and implemented within laboratory workflows to ensure they can generate reliable results in real-world settings. One of the first scientific challenges is identifying appropriate genetic targets that can accurately detect the virus while maintaining specificity against related organisms. For less commonly detected pathogens such as Bundibugyo virus, access to genomic data, specimens (patient isolates), reference materials and positive control samples may be more limited than for better-characterized infectious diseases. At the same time, outbreaks create an urgent need to make testing capability available to support surveillance and outbreak response. This places significant emphasis on the ability to move rapidly from genomic information to assay design, manufacturing and deployment while maintaining scientific rigor. 1/4 Testing solutions must also be evaluated, validated and implemented within laboratory workflows to ensure they can generate reliable results in real-world settings. The ability to move efficiently from pathogen identification to assay development and deployment remains a critical component of outbreak preparedness. Developing diagnostics for emerging pathogens requires both specialised expertise and the ability to respond rapidly as new information becomes available. Following publication of the Bundibugyo virus genome sequence, Roche and TIB Molbiol developed a Research Use Only (RUO) PCR assay within six days. The assay was subsequently evaluated through an international network of expert laboratories, supporting efforts to establish testing capability for epidemiological research, surveillance and outbreak preparedness.
How will the deployment of LightCycler and Magna Pure systems, along with training for local laboratory technicians, strengthen diagnostic capacity in Bunia and the wider region?
Rapid and reliable laboratory testing is central to outbreak response, helping to identify cases, support surveillance activities and inform public health decision-making. The deployment of MagNA Pure and LightCycler systems provides laboratories with the capability to perform molecular testing workflows from nucleic acid extraction through to real-time PCR analysis within the region. However, sustainable diagnostic capacity depends on more than equipment alone. Building local expertise through training and knowledge transfer is equally important. In collaboration with the INSP, Roche is supporting laboratory teams with training and technical assistance as they establish and validate testing workflows and capability in Bunia. By combining technology deployment with workforce development, the initiative aims to not only help address current testing needs, but also strengthen local laboratory capability that can support future infectious disease responses. This approach aligns with broader efforts and WHO recommendations to enhance preparedness and response efforts by developing both infrastructure and workforce capacity.
What are the major challenges involved in validating and deploying molecular diagnostics during an active outbreak, particularly in resource-constrained settings?
One of the primary challenges is balancing the urgency of an outbreak response with the technical and quality requirements necessary to ensure reliable testing. This can be particularly pronounced in resource-constrained settings such as the Democratic Republic of Congo, where the WHO has highlighted laboratory capacity constraints, logistics, workforce availability and security conditions as further complicating deployment efforts. It means that, during an active outbreak, demand for testing can rapidly exceed existing laboratory capacity, meaning laboratories have to expand testing capability while managing these infrastructure limitations, access to materials and availability of trained personnel. Validation is another critical component. Roche and TIB Molbiol have developed a Research Use Only (RUO) PCR assay targeting Bundibugyo virus to support epidemiological research and outbreak surveillance. The assay was independently evaluated by an international network of expert virology laboratories before being supplied to laboratories such as the INSP in the Democratic Republic of 2/4 the Congo (DRC). Local performance verification is being led by the INSP, with Roche providing technical support to ensure reliable implementation using appropriate controls, quality procedures and trained personnel. This coordinated approach helps accelerate diagnostic preparedness and strengthens outbreak surveillance and response. Ultimately, the challenge is not simply deploying a test, but ensuring it can be implemented quickly, safely and consistently within the realities of the local laboratory environment.
How can collaborations between diagnostics companies, public health institutions, and local laboratories contribute to building sustainable testing infrastructure and strengthening outbreak preparedness?
Effective outbreak preparedness depends on building capability before the next emergency occurs. No single organization can address emerging infectious disease threats alone. While equipment and assays are important, sustainable testing infrastructure also requires skilled laboratory personnel, strong quality systems, established workflows and ongoing investment in public health capacity. This is where collaboration can make a significant difference as, when these capabilities are brought together, the benefits extend beyond the immediate outbreak response. Public health institutions provide leadership on surveillance and response priorities, local laboratories contribute critical operational expertise in implementation and patient testing, and diagnostics companies can support these efforts through technology development, scientific expertise, training and access to testing solutions. The current collaboration with the INSP reflects this approach. While supporting the response to the Bundibugyo virus outbreak today, investments in laboratory infrastructure and equipment, workforce training, quality systems and molecular testing workflows can help create stronger, more resilient and lasting diagnostic capability that remains in place after an outbreak has ended.
What lessons from the DRC response could inform the future development of rapid, decentralized molecular testing and surveillance capabilities for emerging infectious diseases?
One important lesson is the value of having testing capability available closer to where outbreaks occur. Rapid access to molecular diagnostics can support earlier case identification, surveillance and public health action, particularly during the early stages of an emerging outbreak. The response also highlights the importance of preparedness before an emergency begins. Rapid implementation during an outbreak depends on having key capabilities already in place, including surveillance systems, assay development expertise, access to reference materials and samples, established laboratory networks, trained personnel and trusted partnerships. Together, these foundations help accelerate testing deployment and strengthen the ability to respond when new infectious disease threats emerge. Another key lesson is the need for flexible molecular diagnostic platforms and infrastructure that can be adapted quickly as emerging pathogens or variants are identified. The ability to move rapidly from pathogen identification to assay development and local validation and testing will remain an important component of future outbreak preparedness. 3/4 Ultimately, effective preparedness requires a combination of technology, partnerships and local capacity building, ensuring that countries are better positioned to detect, monitor and respond to emerging infectious disease threats.
