GenomeMET Project Meeting in Ljubljana: Progress and Insights on reference materials & methods development

On February 11–12, 2025, approximately 30 partners and collaborators of the GenomeMET project gathered at the National Institute of Biology (NIB) in Ljubljana, Slovenia, with 20 more participants joining online.

The „Metrology for genomic profiling to support early cancer detection and precision medicine“ (GenomeMET) project aims to support genomic cancer diagnostics in compliance with the In-vitro Diagnostic Device Regulation (ICDR) by applying metrological principles for the development of reference measurement systems. In detail, GenomeMET will develop reference measurement systems, which in important, since currently the quality and comparability of genetic methods varies greatly. This is partially due because standardization and measurement tools of genetic methods are still in their infancy.

Reference measurement systems consist of three components (details can be found in ISO 17511):

1. A reference measurement method that measures the target analyte
2. A reference material that enables the comparison of reference measurements in different laboratories.
3. A concept for harmonized measurements in clinical laboratories

From the BBMRI.at coordination team Cornelia Stumptner (as Med Uni Graz PI of GenomeMET project) provided valuable input on NSCLC tissue and blood samples. These were collected in accordance with ISO standards for pre-analytical procedures, which were developed as part of SPIDIA4P where Med Uni Graz was project partner. Med Uni Graz further contributes with the  the development of new cell-based reference materials, Both the tissue and the cell-based reference materials were exposed to various pre-analytical conditions to mimic typical situations occurring in the human diagnostic setting. Med Uni Graz, the National Institute of Biology (NIB), and the Candiolo Cancer Institute will further analyse the material and use it for testing the new reference measurement methods.

Since the project works with human samples and data, it has appointed an Ethics Advisor who assesses the ethical merits of the work performed, gives independent recommendations, and, if required, reports to the Commission/ Funding Body on the project’s compliance. The former leader of the Med Uni Graz Ethics Commission, Prof. Josef Haas, Acts and Ethics Advisor for Genome, also attended the meeting.

The successful consortium meeting was rounded off with a tour of the National Institute of Biology (NIB) and it’s laboratories. The NIB is one of Slovenia’s leading public research institutions for life sciences, founded in 1960. With around 200 employees, it conducts fundamental, applied, and developmental research in biotechnology, biophysics, biomedicine, and systems biology, with a growing focus on human health.