Atelier du CCQM: "Metrology for (multi)-omics measurements in clinical diagnostics"

Goals and expected outcomes

Researchers in the clinical area are currently aiming to achieve comprehensive measurements of the complete proteome, genome, transcriptome, epigenome and metabolome. Applying artificial intelligence to this vast amount of data opens the possibility to better understand and predict biological processes and help prevent or treat diseases in the future with specifically designed treatments for each individual. A prerequisite is that the data is reproducible and comparable which requires harmonisation and standardisation protocols to be implemented.

This workshop aims at identifying the current status and opportunities for harmonising and standardising measurement results from translational research to clinical implementation. It will investigate how metrology can be implemented in the omics approach for clinical diagnostics for the benefit of patients (or even better before they become patients). The target audience are stakeholders from clinical research, clinics, IVD industry, NMI/DI as well as laboratory specialists and members from relevant national and international societies such as European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) or Association for Diagnostics and Laboratory Medicine (ADLM).

Goals are to:

• Provide a comprehensive overview of the current and emerging clinical application of genomics (including transcriptomics and epigenomics), proteomics and metabolomics approaches for diagnostic, prevention, research and drug development, including the role of multi omics integration.
• Identify current challenges and initiatives in achieving comparability and traceability in omics measurement procedures including preanalytical, analytical and postanalytical phases between different procedures, laboratories and times.
• Understand stakeholder needs for harmonisation/standardisation in clinical, regulatory, and industrial contexts, to enable reliable (multi )omics applications in diagnostics and research.and support of industry and innovation.

Expected outcomes:

• A report of the insights from the workshop will be prepared for participants and relevant CCQM working groups.
• A peer-reviewed publication capturing key insights, technical challenges, and suggesting a metrology driven roadmap for standardising (multi )omics measurements in clinical contexts.
• Recommendations for future CCQM activities that can support the development of metrology for the (multi-)omics measurements, will be compiled and discussed with the relevant CCQM working groups, including a prioritised list of measurands and methods and considerations of the formation of a CCQM task group, if justified by the stakeholder needs.
• Identification of collaborative opportunities between NMIs/DIs, clinical laboratories, industry, and professional societies to be defined in a potential task group for advancing reproducibility and data quality in (multi )omics diagnostics.