A new independent report by the International Pandemic Preparedness Secretariat (IPPS), the Brown University Pandemic Center and FIND, the global alliance for diagnostics, has identified persistent barriers in diagnostic preparedness that continue to undermine efforts to prevent future pandemics.
The report, Advancing the 100 Days Mission for Diagnostics: 2025 Global Gap Assessment, provides the first in-depth assessment focused specifically on diagnostic readiness in the context of the 100 Days Mission (100DM). The 100DM aims to ensure that safe, effective and affordable medical countermeasures are ready for deployment within 100 days of the identification of a pandemic threat.
Drawing on structured interviews with more than 30 global stakeholders, along with case studies of Ebola, dengue and H5N1 influenza, the report identifies six major and interconnected barriers across the diagnostics ecosystem:
- Limited research and development (R&D), including underinvestment, delays in access to pathogen sequence data, and a lack of clearly defined target product profiles
- Severe challenges in accessing and validating samples, with weak infrastructure for reference standards and biobanking
- Fragmented and inconsistent regulatory systems, which lack harmonised processes and agile emergency pathways
- Highly concentrated manufacturing, with limited regional capacity and technology transfer, particularly in low and middle-income countries
- A suboptimal financing model, characterised by unpredictable demand, lack of financial incentives, fragmented procurement and inadequate mechanisms for surge investment
- Structural and systemic weaknesses, including poor coordination, limited clinical adoption and weak integration with vaccines and therapeutics development pathways.
The report sets out a practical set of actions that funders, regulators, developers, procurement agencies, governments, and global health partners can take to improve diagnostic readiness.
IPPS Chair and Canada’s Chief Science Advisor, Dr Mona Nemer, said: “Timely, trustworthy diagnostics are the foundation of an effective response and of equitable access to care. By strengthening sample access, aligning regulators, investing in regional production and deploying smarter financing, we can deliver tests that serve routine healthcare and pivot rapidly in emergencies. This is how we enhance health security and make the 100 Days Mission a reality for every country.”
Key recommendations include enabling dedicated surge financing for diagnostics, establishing regional evaluation hubs, accelerating regulatory reform and harmonisation, investing in decentralised manufacturing, and introducing market-shaping tools such as volume guarantees and stockpiles. It also calls for stronger integration of diagnostics into broader pandemic preparedness efforts, including operationalising a dedicated working group within the World Health Organization’s Global Diagnostics Coalition.
The assessment concludes that diagnostics remain the weakest link in the arsenal of global medical countermeasures. Delays in test development and deployment not only slow outbreak response but also reinforce inequities in access and impact. Without immediate and sustained action to address the gaps identified, future responses will continue to be hindered by avoidable delays and missed opportunities.
The 100 Days Mission for diagnostics is achievable. This report provides a clear roadmap for stakeholders to deliver concrete, coordinated solutions.
Click here to read the full report on the IPPS website.