2025 White Paper on Recent Issues in Bioanalysis: Biomarkers Calibrators & Stability; Evaluation of NULISA; Neurofilament & Autoantibody Biomarker Assays; Removing IgM Interference; ELISpot & FluoroSpot Best Practices; Modular HD Cytometry; Single-cell Analysis Imaging Cytometry (PART 2A - Recommendations on Biomarkers Discovery, Development, Validation & Regulatory Approval, Ligand-Binding Assays (LBA) and Cell-Based Assays (CBA) PART 2B - Regulatory Agencies' Input on Biomarkers, IVD/CDx and Biomarker Assay Validation (BAV)).

Sarah Hersey, Kristina McGuire, Olga Kholmanskikh, Nicoletta Bivi, Abbas Bandukwala, Binsheng Gong, Chad Irwin, Soma Ray, Michele Gunsior, Andrei Avanesov, Brian Baker, Sarah Bond, Alexander Braun, Alessandra Buoninfante, Francis Dessy