{"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":"codex-gemma-dda1882f352a","candidate_categories":["metaepi_narrow","insufficient_payload"],"consensus_categories":["metaepi_narrow"],"category_scores_codex":[0.01876132,0.001423502,0.002039185,0.008296857,0.000942216,0.0007944531,0.0007703525,0.0009861048,0.001083067],"category_scores_gemma":[0.004139095,0.001332339,0.0008438837,0.01200796,0.001007748,0.001187326,0.0004705767,0.0007850423,0.00004641014],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.001851632,"about_ca_system_score_gemma":0.0006567031,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0004153327,"about_ca_topic_score_gemma":0.0007391528,"domain_scores_codex":[0.983484,0.007438754,0.003293365,0.003140301,0.001366094,0.001277428],"domain_scores_gemma":[0.990721,0.002606725,0.002932446,0.002379932,0.001046047,0.0003137848],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"bench_or_experimental","study_design_gemma":"bench_or_experimental","study_design_scores_codex":[0.00200455,0.003379228,0.253141,0.0005694749,0.01247761,0.000006437447,0.0005139861,0.0003964727,0.6782392,0.0000743044,0.003531877,0.04566588],"study_design_scores_gemma":[0.009927419,0.0006332441,0.1536352,0.003433295,0.02909829,0.00001542392,0.005094236,0.01415015,0.6800259,0.0001974387,0.09871286,0.005076492],"study_design_candidate":"bench_or_experimental","study_design_consensus":"bench_or_experimental","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9614438,0.005789266,0.02112045,0.005005871,0.001140859,0.001845387,0.0005236529,0.0002293246,0.002901435],"genre_scores_gemma":[0.9810483,0.001264993,0.01158041,0.0005046634,0.0000448583,0.0001423617,0.003919689,0.0001065857,0.001388065],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.09950576,"threshold_uncertainty_score":0.9998515,"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."}}