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Biomolecular Measurement Methods for Pathogen Detection

Working Group 8.33

Metrology for genomic profiling to support early cancer detection and precision medicine

Funding

EPM (The European Partnership on Metrology)
(FKZ 22HLT06 GenomeMET)
09/2023 – 08/2026

Partner

  INRIM, LNE, NIB, PTB, TUBITAK, CEA, FPO, INSTAND, MUG, UNITO
in cooperation with
  BIO-RAD, GenQA, LGC, METAS, MHRA, ULE

Droplet sizing for digital PCR

EPM project GenomeMET

Cancer is a major burden in European healthcare systems. Technical advancement in genomics is improving cancer care. It enables earlier and more accurate diagnosis, guiding therapy selection and driving development of targeted therapies (precision medicine). However, quality and comparability of genomic profiling currently varies significantly. One reason is that standardization of genomic diagnostics and metrological means to support the field are in their infancy.Opens external link in new window GenomeMET will develop reference measurement systems (RMS) to support genomic diagnostics of cancer- this will also support compliance with the In-vitro Diagnostic Device Regulation (IVDR EU 2017/746). Reference measurement systems consist of three components. First, a reference measurement procedure that measures the target analyte in SI units. Second, a reference material that allows to compare reference measurements in different laboratories. And third, a concept to implement harmonized measurements for clinical laboratories. Details are described in ISO 17511.