ASM Health

Diagnostic Innovation Institute

Transforming Infectious Disease Diagnostics With AI and Next-Gen Technologies

Executive Summary

Diagnostics are the frontline of clinical care, preventative medicine, public health and outbreak response, yet current systems remain slow, reactive and fragmented, leading to preventable illness and transmission. Despite advances in novel in vitro diagnostic (IVD) methods, next-generation laboratory developed tests (LDTs), point-of-care tools, artificial intelligence (AI), wearables and beyond, progress is stalled by innovation bottlenecks and gaps in efficient, optimal test deployment and use and worsened by global access inequities. These challenges span human, animal and environmental health. The next decade demands a shift to faster, multiplexed, AI-enabled diagnostics that integrate an individual’s analytic results and clinical context with global de-identified health data sets, transforming isolated tests into connected decision-support systems that guide personalized action plans.

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ASM Health (ASM‑H) Proposal:

Establish a global, cross‑sector initiative to streamline discovery‑to‑adoption and ensure every tool—from molecular panels to smartphone AI apps—is used effectively and equitably across One Health monitoring. The initiative will:

Advance diagnostic science by discovering and validating new biomarkers for the diagnosis and treatment of infections.
Validate innovation (LDTs, AI, novel home‑based and mobile platforms) through shared, real‑world evidence and enhanced regulatory readiness.
Strengthen diagnostic stewardship via smarter test utilization, cost‑effectiveness analyses, improved connectedness across diagnostic information streams and outcomes studies.
Enable global deployment, with emphasis on low‑ and middle‑income countries (LMICs).
Build workforce capacity through training and professional development.
Harmonize regulation across domestic frameworks.
Align reimbursement to support sustainable adoption.
Leverage cross‑species innovation to accelerate early zoonotic detection and surveillance.
Deploy federated AI and cross‑sector surveillance models to power One Health monitoring.

Impact:

Faster, context‑aware diagnoses; improved clinical outcomes; connected information streams; earlier outbreak detection; equitable access; and a durable pathway from scientific discovery to real‑world impact.

Core Problems

Modern infectious disease diagnostics are advancing quickly, yet progress is constrained by innovation bottlenecks and stewardship gaps across human, animal, and environmental health.

Innovation Gaps

Industry–clinical disconnects limiting access to clinical samples, end users and real‑world test beds.
Inefficient, redundant LDT development with no shared protocol and validation pipelines, reference platforms or common data standards.
Lack of harmonized validation and regulatory frameworks across markets, delaying multi‑country scale.
Regulatory uncertainty slowing approval and integration of next generation, AI-based, at-home and personalized tools into widespread clinical application.
Underutilized decentralized diagnostics (smartphone interpretation, camera‑enabled microscopy, mobile and at-home platforms), especially in LMICs.
Immature evidence pathways for wearables/health apps requiring fit‑for‑purpose evaluation distinct from lab‑based diagnostics.
Workforce shortages in quality systems, data science/AI, bioinformatics and clinical and public health laboratory sectors.

Stewardship Gaps

No standardized, adaptive testing guidelines that keep pace with new tools and evidence.
Highly variable test utilization and communication across regions and care settings, driving over‑/under‑testing and inconsistent outcomes.
Limited real‑world evidence (RWE) on diagnostic impact and cost‑effectiveness, constraining payer and regulatory decisions.
Under‑resourced labs lack decision support and ability for 2-way integration of data streams, including expert interpretation and integrated clinical tools.
Siloed, non‑interoperable data across One Health domains, impeding early threat detection and coordinated response.

Vision and Goals

Vision:

A unified, high quality diagnostic ecosystem that is effective, innovative and equitable—from hospitals to homes, across human, animal and environmental health worldwide.

Goals:

Drive scientific innovation to discover and develop next-generation diagnostic tools.
Accelerate validation and implementation through shared standards, real-world evidence and regulatory alignment.
Advance diagnostic stewardship with dynamic, evidence-based guidance integrated into care pathways.
Improve equitable access by deploying context-appropriate tools and training globally, especially in LMICs.
Build a skilled workforce to support innovation, implementation and stewardship across One Health sectors.
Integrate data and intelligence by improving information communication systems, leveraging federated AI and cross-sector surveillance for early detection and response.

Priority Innovation Domains

Domain	Description
Collaborative Communities to Advance Diagnostics	Connect basic and translational science researchers, clinical laboratorians and industry partners to accelerate innovation, real-world validation and implementation of IVDs.
LDT Validation & Standards Hub	Coordinate shared protocols, validation approaches and common standards, so new tests scale faster across sites.
AI & Automation Sandbox	Demonstrate clinical value and safety of AI/automation using real‑world pilots and transparent benchmarks, including developing training materials for real-world deployment.
Home‑ & Mobile‑Based Screening	Advance privacy‑aware wearable/phone screening that routes appropriate cases to diagnostics.
Point‑of‑Care (POC) Innovation & Deployment	Evaluate and deploy fit‑for‑purpose POC and other near-patient testing tools with clear workflows for diverse care settings.
Global Diagnostic Access	Package tools, training and partnerships to expand access (especially in LMICs) across One Health.
Policy, Regulatory & Reimbursement	Align pathways with regulators and payers, so promising tools can be adopted sustainably.
Diagnostic Stewardship	Embed evidence‑based ordering and interpretation guidance into clinical systems to improve outcomes.
Training & Workforce	Build skills and credentials across lab, data/AI, stewardship and field deployment at global scale.

Strategic Role of ASM

ASM Health is uniquely positioned to lead this initiative by leveraging its global network, access to scientific expertise, credibility, and operational infrastructure to accelerate diagnostic innovation and adoption. ASM serves as:

A bridge between science, regulation and implementation—connecting researchers, clinicians, regulators and industry to align discovery with real-world use.
A host for shared validation infrastructure—enabling multi-institution studies, harmonized protocols and regulatory engagement to reduce individual investment and speed adoption.
A global access enabler—through ASM journals and international convenings, ensuring equitable deployment and knowledge exchange across regions, including LMICs.
An end-to-end innovation partner and enabler—supporting the full lifecycle from early pilot studies to policy integration and reimbursement alignment.
A convener of cross-sector working groups—integrating AI, One Health and advanced analytics to build next-generation microbial diagnostic and detection systems.

How We Will Execute

ASM Health will deliver an integrated diagnostics agenda through a science first, consortium driven model focused on validation, stewardship, and equitable scaleup:

Set Priorities & Roadmaps: identify key gaps across the Priority Innovation Domains (e.g., LDT Validation & Standards, AI & Automation, POC, Home/Mobile, Stewardship, Global Access, AMR) and maintain living roadmaps tied to pilots and multisite validation.
Influence Regulation & Reimbursement: translate pilot evidence into a Global Playbook Series (validation, regulation, reimbursement, ethics) and convene roundtables with federal agencies and payers to align study designs and evidence standards.
Secure Funding & Partnerships: operate a Funding Radar to identify opportunities, match partners and package multi-site proposals for funding.
Knowledge Dissemination: translate pilot outputs into white papers, playbooks, benchmarking notes, scientific publications and best practices to guide adoption and inform policy across One Health settings.
Data & Standards Infrastructure: anchor pilots in open, interoperable data practices (e.g., FAIR/GA4GH and existing efforts where applicable), enable federated sharing, and operate a shared innovation sandbox for algorithm validation and reproducibility.
Convene & Build Consensus: host expert roundtables and symposia to align academia, public health, regulators and payers on validation criteria, metadata and responsible use.
Workforce Development: deliver role-based training (wet lab, data/AI, clinical interpretation, stewardship) and site activation kits to accelerate implementation, including LMIC deployment pathways.
Consulting and Advisory Services: provide neutral consulting for members on regulatory, clinical, lab operations, LDT/IVD strategy, CLIA/CAP scaffolds, endpoints and study design, biorepositories, IRB/ethics, CMS/reimbursement evidence and global/LMIC considerations.
Engage Industry: offer curated scientific matchmaking and real-world validation pathways; use tiered participation for in-kind resources and early career funding preserving ASM’s neutrality.
Measure Impact: track validation milestones, reproducibility, workforce trained, publications, regulatory acceptance and health outcomes.

Impact

Domain	Metric
Validation	Increased number of diagnostics validated through shared protocols.
Stewardship	Improved test appropriateness: reduced redundant or suboptimal testing and increased high-value testing. Cost savings through more targeted and effective test utilization.
Equity	Deployment of consortium‑supported mobile and point‑of‑care (POC) tools in LMICs.
Workforce	Global increase in certified diagnostic professionals and stewardship leaders.
Policy	Improved regulatory clarity and reimbursement for emerging tools.
Pandemic Preparedness	Enhanced ability to detect and respond to emerging infectious diseases.

Call to Action

The world needs diagnostics that are not only cutting-edge—but also validated, accessible and intelligently deployed.

ASM Health invites partners to:

Join the Integrated Diagnostic Innovation Consortium to shape the future of infectious disease diagnostics.
Co-develop validation protocols, pilot studies and regulatory frameworks that accelerate safe adoption.
Advance training and embed diagnostic stewardship across health systems worldwide.
Sponsor working groups or innovation fellowships to drive targeted breakthroughs.
Collaborate on One Health–aligned pilots using federated AI across clinical, veterinary and environmental settings.

Together, we can validate tools faster, use them smarter and deliver equitable access—everywhere.

Interested in Joining Us?

Be among the first to shape ASM-H initiatives—if you’re driving cutting-edge research or product innovation in the area of diagnostics, reach out to us for early access.