{"id":"W2152774786","doi":"10.1373/clinchem.2012.198739","title":"The Long and Winding Road to FDA Approval of a Novel Prostate Cancer Test: Our Story","year":2012,"lang":"en","type":"article","venue":"Clinical Chemistry","topic":"Prostate Cancer Treatment and Research","field":"Medicine","cited_by":33,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"","keywords":"Prostate cancer; Test (biology); Medicine; Drug approval; Cancer; Internal medicine; Pharmacology; Biology; Drug","routes":{"ca_aff":false,"ca_fund":false,"ca_venue":false,"about_ca":true,"invisible_to_affiliation_only":true},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.04837188,0.001641192,0.002674681,0.002140092,0.005602051,0.01789434,0.003393547,0.03823236,0.01335246],"category_scores_gemma":[0.08788351,0.0009192685,0.001997404,0.001803212,0.01228034,0.03180127,0.005769366,0.04994318,0.007280856],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.005884716,"about_ca_system_score_gemma":0.00890028,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.002782692,"about_ca_topic_score_gemma":0.003380797,"domain_scores_codex":[0.9787456,0.006197521,0.001561452,0.002546897,0.008956416,0.001992145],"domain_scores_gemma":[0.9159808,0.05102133,0.003821472,0.00247823,0.01600846,0.01068985],"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":[0.0003320382,0.0002349353,0.001082708,0.0006267169,0.00009467842,0.001721156,0.0006144501,0.0003649219,0.0008460925,0.05884853,0.8007043,0.1345295],"study_design_scores_gemma":[0.0001436464,0.0003563737,0.0005299675,0.001007834,0.00007150893,0.001586385,0.0009579452,0.0004217605,0.0005471625,0.06063945,0.9335983,0.0001396312],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"commentary","genre_gemma":"empirical","genre_scores_codex":[0.0007475959,0.04028121,0.001824775,0.9345391,0.01677255,0.00001992099,0.000148531,0.0001167322,0.005549547],"genre_scores_gemma":[0.02199152,0.06510334,0.004277215,0.8371934,0.06181079,0.0001167968,0.0003389621,0.0002157909,0.008952231],"genre_candidate":"empirical","genre_consensus":null,"teacher_disagreement_score":0.04837188,"threshold_uncertainty_score":0.255818,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.09264885022634976,"score_gpt":0.4434040720497111,"score_spread":0.3507552218233613,"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."}}