Pandemic Alliance Munich (PAM)

Consortia: LMU Klinikum, Fraunhofer ITMP/Location IIP, Roche

Project Period: 2022-2025

PaPrep1 aims to identify pathogens with pandemic potential and prepare for emerging threats ("disease X"). It spans the development of test prototypes, to enable rapid implementation of diagnostically established mass testing in an emergency situation.

Abstract:
The risk of future pandemics is increasing due to major changes in human behavior and environmental conditions. Population growth, urbanization, and global mobility accelerate pathogen spread, while climate change expands the range of disease carrying vectors. Intensified agriculture and human encroachment on wildlife habitats further increase the likelihood of zoonotic spillover. Together, these factors make the emergence of new infectious diseases more probable, even if exact outbreaks cannot be predicted.

To address this risk, the Diagnostic Toolbox for Pandemic Parameters initiative brings together Roche, LMU Klinikum, and Fraunhofer ITMP IIP in a long term collaboration aimed at strengthening pandemic preparedness. Rather than focusing on individual pathogens, the project adopts a broad, anticipatory strategy covering viruses, bacteria, and fungi, including unknown future threats (“disease X”).

Core activities include prioritizing pathogens based on pandemic potential, producing recombinant antigens and human monoclonal antibodies, and developing adaptable diagnostic assays for early detection and immune profiling. Extensive clinical and animal sample collection ensures real world validation and rapid readiness when outbreaks occur.

Early milestones include successful antibody generation for Yellow Fever and West Nile virus, progress on C. difficile and Aspergillus diagnostics, and establishment of robust clinical networks. Overall, the initiative provides a flexible, collaborative platform designed to enable rapid, effective diagnostic responses to emerging infectious disease threats.

Consortia: LMU Klinikum, Fraunhofer ITMP/Location IIP, Roche

Project Period: 2025-2028

Pursues PaPrep1, to broaden the scope of assay application and methods, where a pathogen priority list was established and a preliminary toolbox for the fast development of diagnostic prototypes against enveloped and non-enveloped viruses, gram-positive spore-forming bacteria and human-pathogenic fungi was established.

Abstract:
Pandemic preparedness requires early detection, rapid diagnostics, and decentralized testing. Building on PaPrep1 — which created a pathogen priority list and an initial diagnostic toolbox — the current initiative aims to develop a scalable, versatile diagnostic ecosystem ready for real world use. The project strengthens collaboration between Roche, Fraunhofer ITMP IIP, and LMU Klinikum, aligning scientific, clinical, and technological expertise to create practical and adaptable diagnostic solutions.

A key goal is expanding assay technologies beyond the basic infrastructure established in PaPrep1. The initiative evaluates lateral flow assays, point of care devices, and multiplex assays to enable rapid, decentralized testing across viral, bacterial, and fungal pathogens. These platforms support early detection, large scale screening, and flexible deployment during outbreaks.

The project also advances decentralized sampling, including AI assisted home testing to reduce pressure on healthcare systems and improve accessibility. High throughput analytical systems accelerate the identification of diagnostic markers and the development of novel binders, enabling rapid response to unknown pathogens. Display technologies and next generation sequencing support fast discovery of specific reagents and deeper insights into host–pathogen interactions.

Overall, the initiative shifts pandemic preparedness from reactive to proactive, creating modular, scalable diagnostic pipelines. By combining innovation, flexibility, and strong institutional collaboration, it aims to ensure rapid development and deployment of diagnostics when new infectious threats emerge.

Consortia: Klinikum der Technischen Universität München (TUM Klinikum), Roche Diagnostics, Technische Universität München (TUM), Helmholtz Munich

Project Period: 2025-2028

PAM-P3M investigates organ damage caused by pandemic viruses, using the hepatitis B virus as a model. It develops viral and immunological cure biomarkers to enable early diagnosis, prognosis, and patient stratification, with transferability to future pandemic pathogens.

Abstract:

Emerging and pandemic viral infections can cause severe, often immune mediated organ damage. A key challenge is the early identification of infections and reliable prediction of disease outcome, as robust predictive biomarkers are still lacking. Using chronic hepatitis B as a model, this consortium addresses this gap through the systematic development and validation of novel viral and immunological cure biomarkers. Although established markers such as HBV DNA and HBsAg are available, they provide an incomplete picture of viral activity and immune control, particularly in specific patient subgroups.

PAM-P3M aims to identify cure biomarkers that discriminate between protective immune responses associated with controlled infection and insufficient immune responses leading to viral persistence, chronic infection, and severe organ damage. To this end, viral parameters, as well as immunological markers, are analyzed individually and in combination and developed into predictive testing systems. Innovative pre analytical approaches, such as antibody–antigen complex dissociation, together with multiparametric immune profiling, enable a more precise assessment of patient immune status.

Close collaboration between academic research, clinical expertise, and pharmaceutical and biotechnology partners supports the translational implementation of the results into commercial diagnostic assays. The concepts and test systems developed are designed to be transferable within the Pandemic Alliance Munich to other pathogens with pandemic potential, enabling rapid scaling of predictive diagnostics in future pandemic scenarios.

Consortia: LMU Klinikum, Fraunhofer ITMP/Location IIP, Roche

Project Period: 2025-2028

This project evaluates non-sputum biomarkers for the diagnosis of tuberculosis in vulnerable populations in endemic regions, aiming to close diagnostic gaps and assess the generalizability of biomarkers in challenging patient populations.

Abstract:

For over a century, the diagnosis of active tuberculosis (TB) has relied on the detection of Mycobacterium tuberculosis (Mtb) in sputum samples. This approach poses significant limitations, as many patients - including children, pregnant women, HIV-infected individuals, and those with extrapulmonary or asymptomatic TB - are often unable to produce sputum. These populations represent nearly 20 % of global TB cases, yet up to 50 % of infections remain undiagnosed. Additionally, they are frequently excluded from clinical studies due to diagnostic challenges, thereby limiting the development of inclusive diagnostics.

Another key limitation in biomarker research is the lack of representation from TB-endemic regions. Biomarkers are often developed using samples from Western populations, which may not be generalizable, particularly for host-derived markers.

This project aims to evaluate non-sputum-based biomarkers for the diagnosis of TB disease using blood, urine, sputum and respiratory swabs. For the sample collection a prospective study will be conducted, with recruitment taking place primarily in Tanzania. A range of assays will be conducted to directly detect the pathogen (including the identification of circulating Mtb cfDNA and antigen detection through specific proteins) and to evaluate signatures based on alterations in the host transcriptome and proteome.

Promising identified biomarkers will be prioritized for further development and potential commercialization, supporting more inclusive and effective TB diagnostics, especially for vulnerable population groups.