5-year budget target
Pillar
Under Defend, diagnostics serve as a rapid-response countermeasure — surging pathogen-specific tests at pandemic scale to guide treatment, containment, and countermeasure deployment.
Five-Year Trajectory
2026
Fund development of pathogen-agnostic diagnostic platforms and establish emergency authorization pathways
2027
Advance pathogen-agnostic diagnostics through development and seek emergency authorization for lead platforms
2028
Authorize pathogen-agnostic diagnostics and build surge manufacturing capacity for rapid test deployment
2029
Validate rapid diagnostic deployment capability through end-to-end exercises
2030
Maintain diagnostic readiness: authorized platforms, surge capacity, and exercised deployment
Current Status of the Field
Sequencing-based, host-response, lateral-flow, and isothermal diagnostic approaches are advancing, but point-of-care pathogen-agnostic diagnostics remain far from routine deployment.
Emergency authorization pathways exist in principle, but they have not been exercised for truly novel pathogen-agnostic tools at the required speed.
The bottleneck is turning promising platforms into authorized, manufacturable, deployable tests before a crisis rather than after demand spikes.
The Problem
If a novel pathogen emerged tomorrow, we could not test for it at scale for weeks or months. Point-of-care pathogen-agnostic diagnostics do not exist at scale. Current diagnostic development pipelines are too slow, emergency authorization pathways have never been tested at the speed required, and surge manufacturing capacity for tests is insufficient for rapid global deployment. During COVID-19, testing shortages lasted months — against a faster-moving engineered pathogen, that delay could be catastrophic.
The Solution
Sequencing-based diagnostics, host-based assays, lateral-flow tests, isothermal amplification platforms (e.g., LAMP), and pathogen-agnostic platforms are maturing rapidly. The urgent priority is to fund development of these platforms, pre-position regulatory pathways, and build surge manufacturing agreements so that diagnostic capability exists before a crisis — not months into one. Diagnostics bridge detection and response: they confirm what surveillance flags and guide the countermeasures that follow.
Objectives
- ◆Pathogen-agnostic diagnostics authorized and deployable at the start of any bioincident, with the ability to surge pathogen-specific tests within weeks
- ◆Point-of-care diagnostics capable of identifying novel pathogens exist at scale, not just in reference laboratories
- ◆Rapid diagnostic scale-up plans are pre-positioned for pandemics of varying intensity
- ◆Emergency authorization pathways for novel diagnostics are established and tested
- ◆Sequencing-based, host-based, lateral-flow, and isothermal amplification (e.g., LAMP) diagnostic platforms are developed and maintained in readiness
Urgent 2026 Milestone
Fund development of pathogen-agnostic diagnostic platforms and establish emergency authorization pathways for rapid deployment.
Long-term Targets
Diagnostic deployment speed
Pathogen-agnostic diagnostics
Diagnostic surge capacity
Year-by-Year
No priority-specific actions recorded for this year. See the 2026 page for overall objectives.
Philanthropy
- •Support completion and operationalization of the first wave of pathogen-agnostic sentinel systems
- •Fund workflow optimization and AI anomaly-detection integration across metagenomic, syndromic, and indicator-based signals
- •Support exercises to validate anomaly review and escalation processes
Private Sector
- •Operate and refine first-wave sequencing and surveillance platforms
- •Integrate anomaly-detection tools into routine workflows with clear escalation paths to public-health authorities
- •Improve automation and data interoperability for faster analysis
Government
- •Complete first-wave deployment of sentinel systems in priority sites
- •Integrate anomaly-detection, syndromic, and indicator-based tools into public-health workflows with named decision owners
- •Exercise investigation, verification, and response protocols
Philanthropy
- •Support global scale-up of metagenomic surveillance to major travel hubs and sentinel sites on six continents
- •Fund exercises to validate end-to-end detection capability from signal to decision to response
- •Support development of a global detection architecture capable of identifying novel rapidly spreading pathogens within 30 days
Private Sector
- •Operate and maintain surveillance infrastructure at larger scale
- •Continue improving analysis tools, interoperability, and real-time detection workflows
Government
- •Scale pathogen-agnostic surveillance to major transit hubs and ports of entry
- •Build stronger international data-sharing and information-exchange mechanisms with predefined decision rights
- •Continue exercising rapid anomaly investigation and response systems from surveillance trigger to action
Philanthropy
- •Support final scale-up and validation of the global early-warning architecture
- •Fund exercises that test performance under engineered-pathogen scenarios and other edge cases
Private Sector
- •Maintain high-quality surveillance infrastructure and rapid data-sharing workflows at scale
- •Continue improving analysis speed, anomaly classification, and operational resilience
Government
- •Reach or exceed coverage goals for major travel hubs and municipalities
- •Maintain rapid anomaly confirmation and response activation capability with named authorities and trained personnel
- •Exercise engineered-pathogen detection and response scenarios regularly
Philanthropy
- •Support maintenance, refinement, and targeted expansion of the global early-warning architecture
Private Sector
- •Maintain and improve surveillance infrastructure, analysis tools, and data-sharing systems
Government
- •Sustain high-coverage pathogen-agnostic surveillance and rapid response capability, with predefined triggers, decision rights, and continued international coordination