Accuracy of early detection of pancreatic cancer using cfDNA methylation marker <i>ZFP30</i> .

Abstract

e16460 Background: Pancreatic cancer (PC) is one of the deadliest malignancies, largely due to the lack of effective early detection methods. Traditional biomarkers like CA19-9 and CEA have limited sensitivity and specificity, particularly in early-stage cases. The EG-Pancreatic Blood Test-E1, a novel assay targeting circulating cfDNA methylation of ZFP30 , offers a promising alternative for early PC detection. This study evaluates its diagnostic performance in Western and Asian populations, with a focus on early-stage detection. Methods: Plasma samples were collected from early-stage PC patients and healthy controls across Western and Asian cohorts. The EG-Pancreatic Blood Test-E1 utilizes a multi-step process, including cfDNA extraction, bisulfite conversion, and methylation-specific quantitative PCR (qPCR) to quantify ZFP30 methylation levels. Sensitivity, specificity, and overall accuracy were evaluated and compared against conventional biomarkers, CA19-9 and CEA. The diagnostic efficacy of ZFP30 methylation was assessed using receiver operating characteristic (ROC) curve analysis and area under the curve (AUC) measurements. Results: The EG-Pancreatic Blood Test-E1 demonstrated exceptional diagnostic performance in detecting pancreatic cancer, particularly in early-stage patients. In the Western cohort, the assay achieved a sensitivity of 92.3%, a specificity of 96.2%, and an overall accuracy of 93.2%. Receiver operating characteristic (ROC) curve analysis confirmed its superior diagnostic capability, with an area under the curve (AUC) of 0.95, surpassing the performance of conventional biomarkers CA19-9 and CEA. When evaluated across both Western and Asian populations, the test exhibited a remarkable sensitivity of 96.0%, specificity of 92.4%, and overall accuracy of 92.5%. The consistency of ZFP30 methylation levels across diverse patient subgroups underscores its robustness as a biomarker and its potential for widespread clinical application. Conclusions: The EG-Pancreatic Blood Test-E1, utilizing ZFP30 cfDNA methylation, represents a groundbreaking advancement in pancreatic cancer diagnostics. Its exceptional accuracy, non-invasive nature, and superior performance over conventional markers position it as a transformative tool for early detection across diverse populations. This innovation has the potential to redefine precision oncology and significantly improve patient survival rates by enabling earlier diagnosis and timely treatment.