Publication on the implementation of the National Strategy for Genomic Medicine in Germany

How has the National Strategy for Genomic Medicine been implemented previously in order to integrate genome sequencing into healthcare in a structured and quality-assured manner and how is this currently being done?

Those involved answer this question jointly in the publication entitled “Germany’s national genomDE strategy” which has recently been published in the online edition of Nature Medicine. This paper offers the first comprehensive insight into the preparation and implementation of the genomDE strategy and the status of the genomDE model project (based on Section 64e of the German federal Social Code, Book V) – from the technical, data protection, and organisational fundamentals to the crucial roles of contributing protagonists.

Key contents of the publication:

• Interdisciplinary collaboration within the framework of genomDE
• Expansion of the national data infrastructure
• Requirements for data collection, quality assurance, and processing
• Current status and outlook of the model project

The National Strategy for Genomic Medicine has paved the way for more precise diagnoses and individualised treatment recommendations for patients with rare and advanced oncological diseases. Germany’s genomic healthcare and research are now set to gather pace. Thereby, BfArM coordinates the implementation as the platform provider and is responsible for operational management of the data platform.

For viewing the publication, please visit: https://rdcu.be/eK8uJ

Establishment of the reimbursement process completed

Following an extensive development and testing phase, initial productive operation has now been gradually started by the clinical data nodes and genome data centres as technical interfaces for data processing. First data transfers to the data nodes and centres ready for operation were successfully completed in July 2025. After receiving a positive report on quality control of the transferred data by the data nodes and centres, BfArM sent the first confirmation tokens to the participating university hospitals. This is a prerequisite for the service to be reimbursed by the respective health insurance funds.
From mid-September 2025 onwards, the health insurance funds reported the start of successful reimbursement of services in the genomDE model project.
This demonstrates that the necessary processes and structures - from data collection and quality control to reimbursement - have been successfully developed and established. This achievement represents a further important milestone in the development of the model project's data platform and genomic medical care in Germany.

Approval of clinical data nodes (CDN) and genome data centers (GDC)

BfArM as the platform operator is responsible for the approval of clinical data nodes and genome data centers in accordance with Section 64e (9) sentence 4 number 1 of the Federal Social Security Code Book V (SGB V).

The following clinical data nodes and genome data centers were approved after application review (as of 31.12.2024)

Clinical data nodes

• Clinical Data Node Dresden (zKDK-ET), University Hospital Dresden
• Clinical Data Node Heidelberg (NCT/DKTK/MASTER), National Center for Tumor Diseases Heidelberg
• Clinical Data Node Cologne (nNGM), University Hospital Cologne
• Clinical Data Node Leipzig (DK-FBREK), University of Leipzig
• Clinical Data Node Leipzig (DK-FDK), University of Leipzig
• Clinical Data Node Tübingen (DNPM), University Hospital Tübingen
• Clinical Data Node Tübingen (NSE), University Hospital Tübingen

Genome Data Centers

• Genome Data Center Berlin, Max Delbrück Center Berlin
• Genome Data Center Dresden, Dresden University of Technology
• Genome Data Center Heidelberg, German Cancer Research Center Heidelberg
• Genome Data Center Cologne, University of Cologne
• Genome Data Center Munich, Technical University of Munich
• Genome Data Center Tübingen, University of Tübingen