Background: Gastrointestinal cancer antigen CA19-9 is known as a valuable marker for the management of patients with pancreatic cancer. Methods: The analytical and clinical performance of the Access ᮋ GI Monitor assay (Beckman Coulter) was evaluated on the UniCel ᮋ DxI 800 Immunoassay System at five different European sites and compared with a reference method, defined as CA19-9 on the Elecsys System (Roche Diagnostics). Results: Total imprecision (%CV) of the GI Monitor ranged between 3.4% and 7.7%, and inter-laboratory reproducibility between 3.6% and 4.0%. Linearity upon dilution showed a mean recovery of 97.4% (SDq7.2%). Endogenous interferents had no influence on GI Monitor levels (mean recoveries: hemoglobin 103%, bilirubin 106%, triglycerides 106%). There was no high-dose hook effect up to 115,000 kU/L. Clinical performance investigated in sera from 1811 individuals showed a good correlation between the Access ᮋ GI Monitor and Elecsys CA19-9 (Rs0.959, slopes1.004, interceptsq0.17). GI Monitor serum levels were low in healthy individuals (ns267, medians6.0 kU/L, 95th percentiles23.1 kU/L), higher