Europe’s ‘Beating Cancer Plan’ aims to tackle cancer through prevention, early detection, treatment, and improving the quality of life for patients and survivors. Many cancer patients experience disease relapse after initial treatment. Measurable Residual Disease (MRD) testing using advanced molecular methods is emerging as a powerful tool for predicting relapse earlier than conventional approaches, guiding treatment, and improving outcomes. However, measuring low levels of MRD remains challenging. Methods are rapidly evolving, and quality and comparability of testing vary due to the lack of metrology frameworks and standards. This hampers confidence in the data and wider implementation of MRD testing.

Why MRD tests need reliable measurement foundations

GenomeMET2 is developing SI-traceable measurement frameworks to improve the accuracy, comparability, and traceability of molecular MRD tests. This is intended to support standardisation, the establishment of clinical MRD thresholds, regulatory qualification, and the accelerated clinical adoption of MRD tests.

From standardisation needs for MRD tests to the standards development process

Within GenomeMET2, DIN leads Task 4.2, “Alignment of standard protocols and standardisation activities for MRD tests”. The aim is to support the development of standard operating procedures (SOPs) and European standardisation documents covering the pre-analytical, analytical, and post-analytical phases of MRD testing across different laboratories and platforms.

DIN analyses standardisation gaps and needs. The results will serve as the basis for developing at least one proposal for a European standardization document based on data generated within the consortium. If this proposal is accepted by CEN or ISO, DIN will coordinate and support the subsequent standards development process.

Project duration

08/2026 – 07/2029

Project coordination

INRIM Istituto Nazionale di Ricerca Metrologica (Italy)

Project partners

• LGC Limited (UK)
• Eidgenössisches Institut für Metrologie (Switzerland)
• Medicines and Healthcare Products Regulatory Agency (UK)
• Nacionalni Institut za Biologijo (Slovenia)
• Turkiye Bilimsel ve Teknolojik Arastirma Kurumu (Türkiye)
• Commissariat à l’énergie atomique et aux énergies alternatives (France)
• Deutsches Herzzentrum München (Germany)
• DIN Deutsches Institut für Normung e. V. (Germany)
• Fondazione del Piemonte per l’Oncologia (Italy)
• GenQA Ltd (UK), INSTAND e.V. (Germany)
• King’s College London (UK)
• METHYS Dx (France)
• Medizinische Universität Graz (Austria)
• Sheffield Teaching Hospitals NHS Foundation Trust (UK)
• Swansea University (UK)
• Universitaetsklinikum Hamburg-Eppendorf (Germany)
• Università degli Studi di Torino (Italy)
• Belgian Volition (Belgium)
• PreAnalytiX GmbH (Switzerland)
• SensID GmbH (Germany)
• Bio-Rad Laboratories, Inc. (USA)
• LGC Clinical Diagnostics Inc. (USA)

Project funding

The project 25HLT07 GenomeMET2 has received funding from the European Partnership on Metrology, co-financed by the European Union’s Horizon Europe Research and Innovation Programme and by the participating states.

Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or EURAMET. Neither the European Union nor the granting authority can be held responsible for them.