Dr. Christine Secher from The Phase 1 Unit and colleagues from seven Danish cancer centers have recently demonstrated close collaboration and taken important steps for future harmonization of molecular diagnostics pipelines.
The study published in Acta Oncologica highlighted substantial variability in the assessment of tumor mutational burden (TMB) across laboratories. The findings originated from the Danish National TMB Ring Trial.
TMB is a tumor-agnostic biomarker associated with improved response to immune checkpoint inhibitors and is used to guide inclusion in clinical trials and treatment decisions. However, there is currently a lack of standardization in the assessment of TMB.
The ring trial included all seven Danish centers that routinely report TMB and compared TMB calculations across different sequencing technologies, including whole genome sequencing, whole exome sequencing, and targeted panels, as well as differences in bioinformatic filtering.
Importantly, the initiative has had positive effects beyond identifying methodological differences. It has improved data quality across sites, strengthened national collaboration, and fostered transparency through shared analyses. Together, these efforts have established a strong foundation for future harmonization of TMB assessment—both nationally and in the broader international context of genomic medicine and targeted therapies.
Danish Cancer Centers cooperating on the Danish National TMB Ring Trial:
- Aalborg University Hospital
- Aarhus University Hospital
- Herlev & Gentofte University Hospital
- Odense University Hospital
- Rigshospitalet - Copenhagen University Hospital
- Vejle Hospital
- Zealand University Hospital