| Summary: | Current blood-based biomarkers for neuroendocrine neoplasms (NENs) lack both sensitivity and specificity. Human circulating progastrin (hPG<sub>80</sub>) is a novel biomarker that can be easily measured in plasma by ELISA. This study is the first to examine hPG<sub>80</sub> in NENs. Plasma hPG<sub>80</sub> was quantified from 95 stage IV NEN patients, using DxPG<sub>80</sub> technology (ECS Progastrin, Switzerland) and compared with hPG<sub>80</sub> concentrations in two cohorts of healthy donor controls aged 50–80 (<i>n</i> = 252) and 18–25 (<i>n</i> = 137). Median hPG<sub>80</sub> in NENs patients was 5.54 pM compared to 1.5 pM for the 50–80 controls and 0.29 pM the 18–25 cohort (<i>p</i> < 0.0001). Subgroup analysis revealed median hPG<sub>80</sub> levels significantly higher than for either control cohort in neuroendocrine carcinoma (NEC; <i>n</i> = 25) and neuroendocrine tumors (NET; <i>n</i> = 70) including the small-cell lung cancer (SCLC) sub-cohort (<i>n</i> = 13). Diagnostic accuracy, estimated by AUCs, was high for NENs, as well as both sub-groups (NEC/NET) when compared to the younger and older control groups. Plasma hPG<sub>80</sub> in NENs may be a diagnostic blood biomarker for both low- and high-grade NENs; further study is warranted. A prospective multi-center trial is ongoing in NET to evaluate hPG<sub>80</sub> as a means of monitoring disease (NCT04750954).
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