A Clinical Laboratory Improvement Amendments/College of American Pathologists–Compliant Noninvasive Laboratory-Developed Test for Early Detection of Pancreatic Ductal Adenocarcinoma
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A Clinical Laboratory Improvement Amendments/College of American Pathologists–Compliant Noninvasive Laboratory-Developed Test for Early Detection of Pancreatic Ductal Adenocarcinoma
A Clinical Laboratory Improvement Amendments/College of American Pathologists–Compliant Noninvasive Laboratory-Developed Test for Early Detection of Pancreatic Ductal Adenocarcinoma
Tajbakhsh, J., Debernardi, S., Blyuss, O., Bai, J., Weng, R., Lo, S., Pandol, S. J., Crnogorac-Jurcevic, T., & Gupta, N. K. (2025). A Clinical Laboratory Improvement Amendments/College of American Pathologists–Compliant Noninvasive Laboratory-Developed Test for Early Detection of Pancreatic Ductal Adenocarcinoma. The Journal of Molecular Diagnostics, 27(1), 54–61. https://doi.org/10.1016/j.jmoldx.2024.10.001
Abstract:
A noninvasive test for earlier detection of pancreatic cancer in individuals at higher risk is currently unavailable. We devised PancSure, a laboratory-developed test based on the protein biomarkers lymphatic vessel endothelial hyaluronan receptor 1 (LYVE1) and regenerating family member 1 β (REG1B), measured in urine by enzyme-linked immunosorbent assay, and commonly used serum/plasma carbohydrate antigen 19.9 (CA19.9), with an updated PancRISK algorithm for data interpretation. The test was validated in 565 patients: 117 asymptomatic patients without any known pancreatic condition or malignancies (21%), 242 symptomatic patients with benign pancreatic diseases (43%), and 206 patients with confirmed cancers (36%); 161 (77.5%) had stage I to II disease, and 45 (22.5%) had stage III to IV disease. PancSure passed all specifications during analytical validation and distinguishes early-stage resectable cancer from asymptomatic individuals with area under the receiver operating characteristic curve (AUC) of 0.93 (95% CI, 0.89-0.97) and 85% to 90% sensitivity (SN) and 78% to 87% specificity (SP); from symptomatic patients with AUC of 0.86 (95% CI, 0.81-0.91) and 83% to 85% SN and 72% to 83% SP; and from all noncancer patients (pooled controls) with AUC of 0.89 (95% CI, 0.84-0.93) and 83% to 85% SN and 78% to 87% SP. PancSure is a noninvasive clinical-grade test with a 48-hour turnover, ready for implementation, providing a viable solution for the earlier detection of pancreatic cancer in at-risk groups for improved patient care.
License type:
Attribution 4.0 International (CC BY 4.0)
Funding Info:
This research / project is supported by the National Research Foundation - I&E Cluster Fund
Grant Reference no. : NRF2020-IE-IECF-005