{"id":"W4416815225","doi":"10.1016/j.esmoop.2025.105909","title":"Regulation of laboratory-developed tests and in-house in vitro diagnostic medical devices in the United States and the European Union—a comparative overview","year":2025,"lang":"en","type":"article","venue":"ESMO Open","topic":"Clinical Laboratory Practices and Quality Control","field":"Medicine","cited_by":5,"is_retracted":false,"has_abstract":true,"ca_institutions":"IONICS Mass Spectrometry (Canada)","funders":"","keywords":"Variety (cybernetics); Diagnostic test; Health care; Process (computing); Medical care; Quality (philosophy); Best practice; Medical device","routes":{"ca_aff":true,"ca_fund":false,"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":[],"consensus_categories":[],"category_scores_codex":[0.008126603,0.00009231031,0.0003932288,0.00009896063,0.00003909234,0.00005625421,0.0002086363,0.00004728026,0.00001916624],"category_scores_gemma":[0.00545002,0.00005121334,0.00001095842,0.0009299504,0.0002111808,0.0001512049,0.0001665645,0.000305359,0.000002076184],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0000184103,"about_ca_system_score_gemma":0.0001835067,"about_ca_topic_candidate":true,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.00343607,"about_ca_topic_score_gemma":0.01824307,"domain_scores_codex":[0.9950688,0.003951598,0.0005223138,0.0001731726,0.0001818987,0.0001022493],"domain_scores_gemma":[0.98907,0.01042283,0.0001543674,0.0002068129,0.0001036882,0.00004230733],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"observational","study_design_gemma":"observational","study_design_scores_codex":[0.003997674,0.001088925,0.9435501,0.0004938515,0.0001705911,0.0001726482,0.01687928,0.00007288168,0.0001582139,0.01618449,0.001337436,0.01589398],"study_design_scores_gemma":[0.006440966,0.00004097811,0.9754751,0.0005991147,0.00004069263,0.000001184693,0.001622099,0.001101248,0.00003398991,0.0004207895,0.01416705,0.00005683282],"study_design_candidate":"observational","study_design_consensus":"observational","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9645338,0.0009818785,0.000006938683,0.03271423,0.00002215622,0.0009357033,0.00000955928,0.000006499488,0.0007892107],"genre_scores_gemma":[0.992497,0.001205525,0.00005446128,0.006156093,0.0000124899,0.00002449147,0.00002449992,0.000006350827,0.00001908001],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.03192502,"threshold_uncertainty_score":0.9996715,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.07849617145854261,"score_gpt":0.4186861173029354,"score_spread":0.3401899458443928,"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."}}