The European Alliance for Personalised Medicine (EAPM) convened a high-level multi-stakeholder side event during the European Society of Pathology (ESP) Congress in Vienna, bringing together leading experts in pathology, oncology, diagnostics, and policy to tackle one of the most pressing challenges in precision oncology today: ensuring equitable, accurate, and universal HER2 testing across cancer types and health systems.
As HER2-targeted therapies expand beyond breast cancer into gastric, lung, colorectal, and rare tumors, testing standards have not evolved at the same pace. Persistent discordance between local and central laboratories, continued reliance on breast-centric scoring methods, and unequal access to digital pathology infrastructure are contributing to variable diagnostic outcomes and widening disparities in care. The event was designed to move beyond identifying gaps and toward coordinated implementation strategies that can be adopted across Europe and beyond.
Setting the Agenda: A Call for Action
Opening remarks from EAPM Executive Director Denis Horgan emphasised the growing urgency to embed diagnostic equity as a fundamental right within cancer care systems. Prof. Nicola Normanno and Dr. Nicola Fusco provided scientific context, outlining the clinical implications of inconsistent HER2 assessment and the need to harmonise testing frameworks across tumor types.
Speakers underscored that HER2 testing must now be understood as a multi-disease, multi-platform diagnostic priority—not a niche workflow limited to specialist centers.
Aligning Policy and Laboratory Practice
The first session highlighted the need for national and EU-level regulatory action to improve quality assurance, adopt tumor-specific interpretation guidelines, and expand the role of digital pathology.
Experts stressed four immediate priorities:
- Standardisation of scoring criteria beyond breast cancer
- Mandatory peer-reviewed laboratory accreditation pathways
- Integration of digital pathology and remote case review
- Faster alignment of clinical guidelines with emerging evidence
Scaling Testing Through System Innovation
The second session showcased real-world implementation models, demonstrating how digital pathology networks, remote consultation systems, and value-based reimbursement can strengthen diagnostic reproducibility and capacity. Case studies illustrated how system-level planning—not technology alone—is the key to sustainable scale-up.
Speakers noted that without investment in workforce training and cross-border quality collaborations, progress will remain fragmented.
Toward a Global Framework for Diagnostic Equity
The concluding discussion turned to global coordination. Participants explored the potential for a Global Diagnostic Equity Compact, to standardise reporting, enable cross-border digital validation, and embed patient rights into diagnostic policy.
Central to this conversation was the recognition that patients not only deserve timely HER2 testing—they deserve clear, transparent result reporting and assurance that their diagnosis meets internationally benchmarked standards.
Next Steps
EAPM will now:
- Integrate outcomes of the session into ongoing policy dialogues at EU and national level
- Continue collaboration with pathology networks and cancer societies to harmonise HER2 interpretation protocols
- Advance proposals to support digital pathology uptake through European funding and policy channels
The messages from this session will also be reflected in EAPM’s upcoming initiatives on diagnostic equity within Europe’s Beating Cancer Plan and the broader precision oncology implementation agenda.
Ensuring that every patient receives a reliable and timely HER2 test result is not only a scientific or clinical priority—it is a health equity imperative.
EAPM will continue working with partners across sectors to ensure policy, practice, and technology align to deliver on this commitment.