Development and Validation of Five Idiopathic Pulmonary Fibrosis (IPF) Biomarker Panels Comprising 12 Immunoassays

Advancing Clinical Diagnostic, Pharmacodynamic and Disease Activity Assessments in IPF
Multiple peer-reviewed publications from various groups consistently report a reoccurring set of blood-based protein biomarkers linked to clinical utility and the course of IPF disease progression. Herein, we describe the analytical validation of the 12 most relevant IPF biomarkers related to: epithelial damage (CYFRA 21-1, SP-D, CA-125, CA-19-9, KL-6), Fibrosis (MMP-7, TN-C, Periostin), Inflammation (PARC, BLC, ICAM-1), and Thrombosis (PAI-1). The 12 assays were optimized into three multiplex panels and two single-plex panels on the Luminex platform. The assays were analytically validated under formal protocols with design controls and pre-defined acceptance criteria. Results will be presented with respect to the Limit of Detection, Sensitivity, Accuracy, Precision, Parallelism, Matrix Interference, Freeze-Thaw Stability, Short-term Analyte Stability, and Sample Reproducibility with supporting data across multiple reagent lots to ensure consistency of results.