Development and Analytical Evaluation of Urine-Based Test for Detection of Pancreatic Cancer.

Background/

Objectives

Pancreatic ductal adenocarcinoma (PDAC) remains a highly lethal malignancy lacking non-invasive functional diagnostic tools. The objective of this study was to develop and analytically validate a qualitative chromogenic urine assay (Panuri) detecting proteolytic activity associated with pancreatic cancer.

Methods

This study reports on the analytical validation of a prototype configuration of the Panuri assay. The assay is based on enzymatic hydrolysis of synthetic peptide substrates measured spectrophotometrically at 410 nm. Results were interpreted qualitatively using predefined OD/h cut-off values (R1: 0.002206; R2: 0.003343; R3: 0.000766). Analytical validation included determination of sensitivity and specificity, precision assessment, and interference testing with microorganisms (107 CFU/mL) and selected endogenous substances.

Results

At the established OD/h cut-off, the assay demonstrated 89% sensitivity (95% CI: 78.5-94.9%) and 75% specificity (95% CI: 64.8-83.5%). Precision studies demonstrated repeatability, within-laboratory precision, and inter-laboratory reproducibility, with coefficients of variation below 10%. Interference from endogenous substances was limited under testing conditions, whereas high microbial contamination induced classification shifts. Further analytical studies are ongoing to assess the impact of exogenous interferents, including drugs and supplements, in accordance with extended interference evaluation requirements.

Conclusions

The Panuri assay demonstrates predefined analytical performance characteristics for qualitative detection of proteolytic activity in the urine under the conditions evaluated in this study.