A CLIA/CAP Compliant Noninvasive Laboratory Developed Test for Early Detection of Pancreatic Ductal Adenocarcinoma.

A noninvasive test for earlier detection of pancreatic cancer in individuals at higher risk is currently unavailable. To fill this void, we devised PancSure, a laboratory developed test in compliance with clinical regulations. PancSure is based on the protein biomarkers LYVE1 and REG1B, measured in urine by enzyme-linked immunosorbent assay, and commonly utilized serum/plasma CA19.9, with an updated version of the PancRISK algorithm for data interpretation. The test was validated in a cohort of 565 patients: 117 (21%) asymptomatic patients without any known pancreatic condition or malignancies, 242 (43%) symptomatic patients with benign pancreatic diseases and 206 (36%) confirmed cancers; 161 (77.5%) stages I-II and 45 (22.5%) stages III-IV. PancSure passed all specifications during analytical validation and distinguishes early-stage resectable cancer from asymptomatic individuals with AUC of 0.93 (0.89-0.97, 95% CI) and 85-90% sensitivity (SN) and 78-87% specificity (SP); from symptomatic patients with AUC of 0.86 (0.81-0.91, 95% CI) and 83-85% SN and 72-83% SP; and from all non-cancer patients (pooled controls) with AUC of 0.89 (0.84-0.93, 95% CI) and 83-85% SN and 78-87% SP. PancSure is a noninvasive clinical-grade test with a 48-hour turnover, ready for implementation without any costly instrumentation, thus providing a viable solution for the earlier detection of pancreatic cancer in at risk groups for improved patient care.