Background The evolution of bulk and spatial Omics technologies coincides with a need for novel biomarkers in clinical studies for diagnostics, prognostics, agnostics, and/or mechanisms of action. Cerba Research is dedicated to validating research-based technologies for use in global clinical studies.

Methods Cerba Research has developed internal workflows for bulk (nCounter) and spatial (GeoMx) RNA analysis on formalin fixed paraffin embedded (FFPE) tissues with NanoString platforms. The validation tests of robustness, precision, and inter-site are presented here.

Results nCounter (n=12) and GeoMx (n=16) workflows were successfully applied to a range of solid tumor FFPE tissue including lung, breast, skin, and colon showing robustness of the methods. A high correlation of inter- and intra-assay precision was also measured for RNA extraction (quantity and quality(DV200)) and nCounter assays with the PanCancer IO360 panel (R²≥0.97). Precision of the GeoMx whole transcriptome atlas assay with NGS readout showed an 88% repeatability correlation and 79% for reproducibility. Four non-small cell lung cancer samples were processed (FFPE curls, RNA extraction, nCounter PanCancer Pathway Panel) at both Cerba Research and an external sub-contracted lab. Inter-site analysis showed a correlation of R²=0.94.

Conclusions These results demonstrate the reliability of these methods at Cerba Research giving confidence to clients for use in clinical studies. Cerba Research is committed to expand these validations to maximize a bulk and spatial Omics offering.