{"id":"W7126048515","doi":"10.1080/17576180.2025.2599698","title":"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))","year":2025,"lang":"en","type":"article","venue":"Bioanalysis","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":3,"is_retracted":false,"has_abstract":true,"ca_institutions":"Health Canada","funders":"Agenzia Italiana del Farmaco, Ministero della Salute; Health Canada; Eisai; U.S. Food and Drug Administration; Moderna; Regeneron Pharmaceuticals; Alnylam Pharmaceuticals; Alexion Pharmaceuticals; Daiichi Sankyo Europe; Exelixis; GlaxoSmithKline; Pfizer; AstraZeneca; Eli Lilly and Company; Bristol-Myers Squibb","keywords":"White paper; Excellence; Harmonization; Agency (philosophy); Bioanalysis; Best practice; Quality (philosophy); Expert opinion","routes":{"ca_aff":true,"ca_fund":true,"ca_venue":false,"about_ca":false,"invisible_to_affiliation_only":false},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.01332765,0.001549879,0.0009861665,0.001679654,0.002085885,0.00919464,0.003547877,0.01159743,0.07042737],"category_scores_gemma":[0.01132005,0.000861274,0.001181039,0.001532378,0.002048975,0.003856666,0.002336128,0.006831822,0.06645694],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.004218617,"about_ca_system_score_gemma":0.01271266,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.007246493,"about_ca_topic_score_gemma":0.01491975,"domain_scores_codex":[0.9900402,0.001179055,0.0006426846,0.001132455,0.006151327,0.0008542871],"domain_scores_gemma":[0.9784876,0.00296926,0.001484627,0.000729029,0.01296827,0.003361281],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"not_applicable","study_design_gemma":"not_applicable","study_design_scores_codex":[0.00006373558,0.00006363093,0.0001170586,0.0002155606,0.00000626404,0.0000826394,0.00004382743,0.00009269777,0.00176368,0.002067375,0.9512937,0.04418979],"study_design_scores_gemma":[0.000006207601,0.00002411852,0.0002612906,0.0001300226,0.000003160251,0.00003361771,0.00002612184,0.00005937652,0.0006961147,0.0004361408,0.9983169,0.000006968273],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"other","genre_gemma":"methods","genre_scores_codex":[0.002444977,0.05128839,0.01250837,0.2247562,0.29333,0.00134426,0.004309254,0.001476557,0.408542],"genre_scores_gemma":[0.005847459,0.01430053,0.006148421,0.06811902,0.03544605,0.0003696867,0.003566024,0.0009151598,0.8652875],"genre_candidate":"methods","genre_consensus":null,"teacher_disagreement_score":0.07042737,"threshold_uncertainty_score":0.235603,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.0952726767801078,"score_gpt":0.3458211480313249,"score_spread":0.250548471251217,"validation_status":"score_only:v0-immature-baseline","note":"Baseline scores from an immature model (maturity gate not passed). Scores rank; they never assert a category."}}