Abstract 675: Performance of highly sensitive molecular biomarker for pancreatic cancer detection

Background: Pancreatic cancer is one of the most lethal malignancies, with resection being the only potentially curative treatment. However, due to the absence of effective early detection or screening, most patients are diagnosed at an advanced stage with a five-year survival rate of only 3%. Several genetic mutation-based biomarkers are already in use for cancer diagnosis. Epigenetic alterations, recognized as early events in tumorigenesis, also play a critical role in cancer development. The integration of mutational and epigenetic biomarkers has significant potential to enhance the accuracy of diagnostic panels for early cancer detection. By applying advanced mathematical models to integrate multi-level genomic and epigenetic data, Epi One has identified highly accurate biomarker panel for the early detection of pancreatic cancer. We developed pancreaScout - a simple, cost-effective, and highly sensitive qPCR assay for detecting the biomarker panel associated with pancreatic cancer. In this report, we present the performance of pancreaScout for the biomarker panel in human tissue and blood samples. Methods: Eighty-seven human primary tissue samples and 48 blood samples with IRB consent were collected DNA was extracted from human primary samples DNA underwent bisulfite conversion to enable methylation-specific analysis, with quantitative methylation-specific PCR (qMSP) performed to quantify DNA methylation levels. In parallel, quantitative PCR (qPCR) was conducted on untreated DNA to detect genetic mutations. qPCR data analysis was carried out to calculate scores, which reflect the levels of mutation and methylation in samples. Results: Identification of a pancreatic cancer detection panel with two mutation- and four DNA methylation- biomarkers. Validation of the biomarker panel using qPCR in 87 tissue samples (65 pancreatic cancer patients and 22 adjacent normal controls), achieving 87% sensitivity and 90% specificity. Validation of the biomarker panel using qPCR in 41 blood samples (including 41 pancreatic cancer patients and 7 normal individuals) and achieved 69% sensitivity and 100% specificity. Conclusions: pancreaScout is a sensitive and specific diagnostic panel for pancreatic cancer detection for both tissue and blood samples. Compared to sequencing-based methods for early cancer detection, pancreaScout assay achieves comparable sensitivity in blood tests. The simplicity of pancreaScout adds significant value in the fight against pancreatic cancer. Citation Format: Sophia F. Fang, Neng Yang. Performance of highly sensitive molecular biomarker for pancreatic cancer detection [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 675.