Abstract
BACKGROUND: Pancreatic cancer continues to retain the highest mortality rate among all major organ cancers. New strategies for early detection are being proposed to increase long-term survival. A plethora of molecular markers are discovered yearly, but so far none have demonstrated screening utility. SUMMARY: Promising discovery technologies include affinity-based proteomics and ddPCR. In the validation phase, researchers must decide on key benchmark criteria, what type of pancreatic lesions are desirable to find early through molecular screening, and when to terminate the biomarker study and return to the discovery phase. If the biomarkers meet set benchmarks, retrospective analysis should be conducted in relevant cohorts based on intended use, followed by prospective real-world evaluation. Lastly, regulatory approval, incorporation into clinical practice guidelines, and thorough health economic evaluations must be completed before the screening markers can be fully implemented. KEY MESSAGES: In this review, important strategies and phases for molecular biomarker development in pancreatic cancer have been outlined.