{ "schema_version": "1.0", "generated": "2026-05-14", "description": "MASLD/MASH biomarker qualification mock dataset across FDA BQP, EMA, ICH M10, KFDA, DDTII, CTTI pathways", "entries": [ { "biomarker_id": "BMK-001", "name": "ELF (Enhanced Liver Fibrosis) score", "biomarker_type": "ECM", "pathway": "FDA-BQP", "submission_date": "2024-03-12", "decision_date": "2025-09-04", "status": "qualified", "context_of_use": "prognosis", "indication": "MASH with advanced fibrosis (F3-F4)", "population": "Adults with biopsy-confirmed MASH", "analytical_validation": "CV<10%, LoD 7.7 ng/mL (HA), 4.05 ng/mL (PIIINP), Siemens ADVIA Centaur", "clinical_validation": "AUROC 0.81 (F3-F4 vs F0-F2), LITMUS imaging cohort n=966", "clinical_utility": "Enrichment of phase 3 MASH trials, surrogate for major adverse liver outcomes", "tier_rank": 1 }, { "biomarker_id": "BMK-002", "name": "PRO-C3 (N-terminal pro-peptide of type III collagen)", "biomarker_type": "ECM", "pathway": "FDA-BQP", "submission_date": "2023-11-08", "decision_date": "2025-06-22", "status": "letter_of_support", "context_of_use": "monitoring", "indication": "MASH fibrosis response", "population": "Adults in MASH interventional trials", "analytical_validation": "CV<12%, Nordic Bioscience competitive ELISA", "clinical_validation": "Δ PRO-C3 correlated with histologic fibrosis improvement (r=0.42, p<0.001) in pooled phase 2b cohort n=482", "clinical_utility": "Dynamic monitoring biomarker for fibrosis progression/regression", "tier_rank": 2 }, { "biomarker_id": "BMK-003", "name": "FIB-4 index", "biomarker_type": "NIT", "pathway": "EMA-QO", "submission_date": "2024-06-30", "decision_date": "2025-12-15", "status": "qualified", "context_of_use": "screening", "indication": "MASLD risk stratification in primary care", "population": "Adults with T2D, obesity, or metabolic syndrome", "analytical_validation": "Derived from AST, ALT, platelet, age - standard chemistry harmonization (IFCC)", "clinical_validation": "NPV>90% for advanced fibrosis at cutoff <1.30; LITMUS-DeLIVER cohort n=4321", "clinical_utility": "Two-step pathway gatekeeper before specialist referral", "tier_rank": 1 }, { "biomarker_id": "BMK-004", "name": "FAST (FibroScan-AST) score", "biomarker_type": "NIT", "pathway": "EMA-LoS", "submission_date": "2024-09-15", "decision_date": "2025-08-01", "status": "letter_of_support", "context_of_use": "diagnosis", "indication": "At-risk MASH (NAS>=4 and F>=2)", "population": "Adults with suspected MASH", "analytical_validation": "VCTE CAP/LSM standardized acquisition + serum AST (IFCC)", "clinical_validation": "AUROC 0.81, rule-in 0.67/rule-out 0.35 dual cutoffs", "clinical_utility": "Trial enrichment, reduces unnecessary biopsy by ~50%", "tier_rank": 2 }, { "biomarker_id": "BMK-005", "name": "MAST (MRI-AST) score", "biomarker_type": "NIT", "pathway": "FDA-BQP", "submission_date": "2025-01-20", "decision_date": null, "status": "under_review", "context_of_use": "diagnosis", "indication": "At-risk MASH", "population": "Adults in tertiary hepatology", "analytical_validation": "MRE + MRI-PDFF + serum AST (IFCC harmonized)", "clinical_validation": "AUROC 0.93 for fibrotic NASH (NIMBLE imaging arm n=232)", "clinical_utility": "High specificity diagnostic enrichment tool", "tier_rank": 1 }, { "biomarker_id": "BMK-006", "name": "MRI-PDFF (proton density fat fraction)", "biomarker_type": "IMAGING", "pathway": "FDA-BQP", "submission_date": "2022-04-11", "decision_date": "2024-11-30", "status": "qualified", "context_of_use": "monitoring", "indication": "MASH treatment response (steatosis)", "population": "Adults in MASH interventional trials", "analytical_validation": "3D chemical shift encoded MRI, multi-vendor (GE/Siemens/Philips) harmonization per QIBA profile", "clinical_validation": "Relative reduction >=30% predicts histologic response, RESOLVE-IT/MAESTRO-NASH pooled n=874", "clinical_utility": "Primary endpoint or trial enrichment for steatosis-targeted therapeutics", "tier_rank": 1 }, { "biomarker_id": "BMK-007", "name": "MRE (magnetic resonance elastography)", "biomarker_type": "IMAGING", "pathway": "FDA-BQP", "submission_date": "2023-02-09", "decision_date": "2025-03-21", "status": "qualified", "context_of_use": "staging", "indication": "MASH fibrosis staging", "population": "Adults with MASH", "analytical_validation": "2D-GRE MRE at 60Hz, QIBA profile, multi-site CV <8%", "clinical_validation": "AUROC 0.92 for F>=3 vs F<3; cutoff 3.63 kPa; NIMBLE n=242", "clinical_utility": "Trial enrichment, longitudinal staging", "tier_rank": 1 }, { "biomarker_id": "BMK-008", "name": "VCTE (vibration-controlled transient elastography, FibroScan)", "biomarker_type": "IMAGING", "pathway": "EMA-QO", "submission_date": "2023-10-04", "decision_date": "2025-05-18", "status": "qualified", "context_of_use": "screening", "indication": "MASLD with at-risk fibrosis", "population": "Adults with metabolic risk factors", "analytical_validation": "M/XL probe, standardized acquisition (>=10 valid, IQR/median<30%)", "clinical_validation": "AUROC 0.85 for F>=3, cutoffs 8/12 kPa (rule-out/rule-in)", "clinical_utility": "Primary care referral gating, two-step pathway", "tier_rank": 1 }, { "biomarker_id": "BMK-009", "name": "PNPLA3 rs738409 genotype (I148M)", "biomarker_type": "GENETIC", "pathway": "FDA-BQP", "submission_date": "2024-12-01", "decision_date": null, "status": "under_review", "context_of_use": "prognosis", "indication": "MASLD progression risk", "population": "Adults with MASLD", "analytical_validation": "TaqMan SNP assay or NGS panel, CLIA-equivalent QC", "clinical_validation": "Per-allele OR 2.1 for advanced fibrosis (meta-analysis n=72,000)", "clinical_utility": "Risk stratification, potential companion biomarker for siRNA candidates", "tier_rank": 2 }, { "biomarker_id": "BMK-010", "name": "HSD17B13 rs72613567 genotype", "biomarker_type": "GENETIC", "pathway": "EMA-LoS", "submission_date": "2025-02-14", "decision_date": null, "status": "under_review", "context_of_use": "prognosis", "indication": "Protective variant for MASLD progression", "population": "Adults with MASLD", "analytical_validation": "TaqMan SNP assay", "clinical_validation": "Per-allele OR 0.69 for cirrhosis, GENFIT-LITMUS n=2,415", "clinical_utility": "Risk stratification, target validation for ASO program", "tier_rank": 3 }, { "biomarker_id": "BMK-011", "name": "NIS4 (cytokeratin-18, A2M, HbA1c, miR-34a)", "biomarker_type": "ECM", "pathway": "EMA-LoS", "submission_date": "2023-08-22", "decision_date": "2025-04-09", "status": "letter_of_support", "context_of_use": "diagnosis", "indication": "At-risk MASH", "population": "Adults with T2D and/or obesity", "analytical_validation": "Multi-analyte ELISA + qPCR, CV<15%", "clinical_validation": "AUROC 0.83 (RESOLVE-IT validation n=465)", "clinical_utility": "Trial enrichment, non-invasive diagnosis", "tier_rank": 2 }, { "biomarker_id": "BMK-012", "name": "NIS2+ (miR-34a + YKL-40 refinement)", "biomarker_type": "ECM", "pathway": "EMA-QO", "submission_date": "2025-03-04", "decision_date": null, "status": "under_review", "context_of_use": "diagnosis", "indication": "At-risk MASH", "population": "Adults with metabolic risk factors", "analytical_validation": "qPCR + ELISA, CV<12%", "clinical_validation": "AUROC 0.81, pooled LITMUS n=1,002", "clinical_utility": "Simplified two-analyte at-risk MASH detection", "tier_rank": 2 }, { "biomarker_id": "BMK-013", "name": "cT1 (LiverMultiScan, iron-corrected T1)", "biomarker_type": "IMAGING", "pathway": "FDA-BQP", "submission_date": "2024-05-19", "decision_date": null, "status": "under_review", "context_of_use": "monitoring", "indication": "MASH inflammation/ballooning surrogate", "population": "Adults in MASH trials", "analytical_validation": "MOLLI T1 mapping, iron-corrected via T2*, multi-vendor harmonization", "clinical_validation": "Δ cT1 correlated with NAS reduction (LITMUS n=455)", "clinical_utility": "Monitoring biomarker for anti-inflammatory therapeutics", "tier_rank": 2 }, { "biomarker_id": "BMK-014", "name": "PathAI AIM-NASH (AI digital pathology)", "biomarker_type": "AI-SAMD", "pathway": "FDA-BQP", "submission_date": "2024-08-30", "decision_date": "2025-11-12", "status": "qualified", "context_of_use": "monitoring", "indication": "MASH histologic endpoint adjudication", "population": "Adults in MASH biopsy-based trials", "analytical_validation": "Whole slide imaging, multi-scanner (Aperio/Hamamatsu) concordance >0.85", "clinical_validation": "Concordance with central pathology consensus kappa 0.62, repeatability ICC 0.91", "clinical_utility": "Standardized histology endpoint reading, reduces inter-reader variability", "tier_rank": 1 }, { "biomarker_id": "BMK-015", "name": "HistoIndex SHG/TPEF (qFibrosis)", "biomarker_type": "AI-SAMD", "pathway": "EMA-LoS", "submission_date": "2025-04-02", "decision_date": null, "status": "under_review", "context_of_use": "monitoring", "indication": "MASH fibrosis quantitative measurement", "population": "Adults in MASH trials", "analytical_validation": "Stain-free SHG/TPEF imaging, automated quantification", "clinical_validation": "Detects sub-stage fibrosis change, NIMBLE-imaging pilot n=120", "clinical_utility": "Continuous fibrosis quantification for trial endpoints", "tier_rank": 2 }, { "biomarker_id": "BMK-016", "name": "SHIELD (deep-learning MASH classifier)", "biomarker_type": "AI-SAMD", "pathway": "FDA-BQP", "submission_date": "2025-05-01", "decision_date": null, "status": "under_review", "context_of_use": "diagnosis", "indication": "At-risk MASH from routine labs", "population": "Adults with T2D or obesity in primary care", "analytical_validation": "Model card v2.1, fairness audit across 4 cohorts", "clinical_validation": "AUROC 0.84 external validation, NIMBLE-DeLIVER n=1,840", "clinical_utility": "Primary care screening tool, EHR-deployable", "tier_rank": 2 }, { "biomarker_id": "BMK-017", "name": "LiMAx (13C-methacetin breath test)", "biomarker_type": "BREATH", "pathway": "EMA-LoS", "submission_date": "2024-11-18", "decision_date": null, "status": "under_review", "context_of_use": "monitoring", "indication": "Hepatic functional capacity in MASH", "population": "Adults with cirrhotic or pre-cirrhotic MASH", "analytical_validation": "Isotope ratio mass spectrometry, CV<5%", "clinical_validation": "Correlates with MELD-Na (r=-0.51) and decompensation events", "clinical_utility": "Functional surrogate for advanced disease", "tier_rank": 3 }, { "biomarker_id": "BMK-018", "name": "HepQuant SHUNT", "biomarker_type": "BREATH", "pathway": "FDA-BQP", "submission_date": "2025-01-08", "decision_date": null, "status": "under_review", "context_of_use": "prognosis", "indication": "Portal hypertension surrogate in MASH cirrhosis", "population": "Adults with compensated MASH cirrhosis", "analytical_validation": "Dual-label cholate clearance, LC-MS readout", "clinical_validation": "DSI threshold 22 predicts CSPH (AUROC 0.85)", "clinical_utility": "Non-invasive portal hypertension assessment", "tier_rank": 2 }, { "biomarker_id": "BMK-019", "name": "CLDQ-NAFLD (chronic liver disease questionnaire)", "biomarker_type": "PRO", "pathway": "FDA-BQP", "submission_date": "2024-04-25", "decision_date": "2025-10-05", "status": "qualified", "context_of_use": "monitoring", "indication": "HRQoL in MASLD/MASH trials", "population": "Adults with biopsy-confirmed MASH", "analytical_validation": "29-item self-report, recall 2 weeks, Cronbach alpha 0.92", "clinical_validation": "MCID 0.5 derived from RESOLVE-IT/MAESTRO-NASH", "clinical_utility": "Patient-reported endpoint for regulatory submissions", "tier_rank": 1 }, { "biomarker_id": "BMK-020", "name": "NASH-CHECK (symptom diary)", "biomarker_type": "PRO", "pathway": "EMA-QO", "submission_date": "2024-10-09", "decision_date": "2025-12-01", "status": "qualified", "context_of_use": "monitoring", "indication": "MASH-specific symptom burden", "population": "Adults with MASH", "analytical_validation": "12-item daily diary, eCOA-compatible, test-retest ICC 0.84", "clinical_validation": "Sensitive to histologic response (effect size 0.4)", "clinical_utility": "Daily symptom endpoint for label claims", "tier_rank": 1 }, { "biomarker_id": "BMK-021", "name": "ELF score - KFDA equivalence dossier", "biomarker_type": "ECM", "pathway": "KFDA", "submission_date": "2025-09-20", "decision_date": null, "status": "submitted", "context_of_use": "prognosis", "indication": "MASH with advanced fibrosis", "population": "Korean adults with biopsy-confirmed MASH (KASL cohort)", "analytical_validation": "Bridging study n=120 Korean subjects, Siemens ADVIA Centaur, CV<10%", "clinical_validation": "AUROC 0.79 for F>=3 in Korean cohort, KASL-LITMUS-Korea sub-study", "clinical_utility": "MFDS equivalence to FDA BQP qualification, HIRA reimbursement pending", "tier_rank": 2 }, { "biomarker_id": "BMK-022", "name": "MRE - KFDA SaMD pathway", "biomarker_type": "IMAGING", "pathway": "KFDA", "submission_date": "2025-07-14", "decision_date": null, "status": "under_review", "context_of_use": "staging", "indication": "MASH fibrosis staging in Korean adults", "population": "Korean adults at tertiary hepatology centers", "analytical_validation": "Multi-site QIBA profile bridging, Seoul/Busan/Daegu centers", "clinical_validation": "AUROC 0.91 in Korean validation cohort n=380", "clinical_utility": "MFDS Class III medical device + 동등성 to FDA BQP", "tier_rank": 1 }, { "biomarker_id": "BMK-023", "name": "FAST score - HIRA reimbursement evidence package", "biomarker_type": "NIT", "pathway": "KFDA", "submission_date": "2025-10-30", "decision_date": null, "status": "submitted", "context_of_use": "diagnosis", "indication": "At-risk MASH detection in Korean primary care/clinic", "population": "Korean adults with T2D or obesity", "analytical_validation": "VCTE bridging study Korean population n=480", "clinical_validation": "AUROC 0.78 in KASL cohort", "clinical_utility": "HIRA 신의료기술평가 candidate, 동등성 to EMA letter of support", "tier_rank": 2 }, { "biomarker_id": "BMK-024", "name": "PNPLA3/HSD17B13 polygenic risk score (Korean panel)", "biomarker_type": "GENETIC", "pathway": "DDTII", "submission_date": "2025-06-05", "decision_date": null, "status": "workshop_discussion", "context_of_use": "prognosis", "indication": "MASLD progression risk in East Asians", "population": "Korean adults with MASLD (KoGES + KASL cohort)", "analytical_validation": "Korean reference allele frequencies (PNPLA3 G allele 0.47)", "clinical_validation": "PRS predictive C-index 0.68 in KoGES n=8,420", "clinical_utility": "DDTII workshop topic; KFDA companion diagnostic precedent", "tier_rank": 3 }, { "biomarker_id": "BMK-025", "name": "MRI-PDFF - ICH M10 bioanalytical harmonization", "biomarker_type": "IMAGING", "pathway": "ICH-M10", "submission_date": "2024-07-22", "decision_date": "2025-04-30", "status": "harmonized", "context_of_use": "monitoring", "indication": "MASH steatosis response across regions", "population": "Global trial participants", "analytical_validation": "ICH M10-aligned multi-vendor QC, central reading lab harmonization", "clinical_validation": "Cross-regional concordance ICC 0.94 (US/EU/Korea/Japan)", "clinical_utility": "Regulatory acceptance across ICH regions", "tier_rank": 1 }, { "biomarker_id": "BMK-026", "name": "CTTI MASH biomarker working group consensus - composite NIT", "biomarker_type": "NIT", "pathway": "CTTI", "submission_date": "2024-09-30", "decision_date": "2025-08-14", "status": "consensus_published", "context_of_use": "diagnosis", "indication": "At-risk MASH enrichment in pragmatic trials", "population": "Adults at metabolic risk in real-world settings", "analytical_validation": "Two-step FIB-4 + VCTE/ELF protocol", "clinical_validation": "Operational performance in 12 pragmatic sites", "clinical_utility": "Standardized trial enrichment recommendation", "tier_rank": 2 }, { "biomarker_id": "BMK-027", "name": "CK-18 M30/M65 (apoptosis biomarker)", "biomarker_type": "ECM", "pathway": "EMA-LoS", "submission_date": "2023-05-18", "decision_date": "2024-12-08", "status": "letter_of_support", "context_of_use": "monitoring", "indication": "MASH hepatocyte injury", "population": "Adults in MASH trials", "analytical_validation": "ELISA, CV<14%", "clinical_validation": "Modest AUROC 0.71 for NASH vs NAFL, supportive only", "clinical_utility": "Pharmacodynamic biomarker for apoptosis-targeted compounds", "tier_rank": 3 }, { "biomarker_id": "BMK-028", "name": "MEFIB (MRE + FIB-4)", "biomarker_type": "NIT", "pathway": "FDA-BQP", "submission_date": "2024-02-28", "decision_date": "2025-09-25", "status": "qualified", "context_of_use": "diagnosis", "indication": "Significant fibrosis (F>=2) MASH", "population": "Adults with MASH", "analytical_validation": "MRE + FIB-4 dual cutoff combination", "clinical_validation": "PPV 0.97 rule-in, NPV 0.92 rule-out (multi-center n=908)", "clinical_utility": "Sequential rule-in/rule-out for trial enrollment", "tier_rank": 1 }, { "biomarker_id": "BMK-029", "name": "ProC6 / endotrophin (type VI collagen)", "biomarker_type": "ECM", "pathway": "EMA-LoS", "submission_date": "2024-12-22", "decision_date": null, "status": "under_review", "context_of_use": "prognosis", "indication": "MASH outcomes prediction", "population": "Adults with biopsy-confirmed MASH", "analytical_validation": "Nordic Bioscience competitive ELISA", "clinical_validation": "Hazard ratio 1.8 per SD for MALO (LITMUS outcomes n=1,460)", "clinical_utility": "Outcomes-focused prognostic biomarker", "tier_rank": 2 }, { "biomarker_id": "BMK-030", "name": "MARC1 rs2642438 protective variant", "biomarker_type": "GENETIC", "pathway": "DDTII", "submission_date": "2025-03-18", "decision_date": null, "status": "workshop_discussion", "context_of_use": "prognosis", "indication": "MASLD/MASH protective variant", "population": "Adults with metabolic risk", "analytical_validation": "TaqMan SNP assay", "clinical_validation": "Per-allele OR 0.81 for cirrhosis (UK Biobank + LITMUS pooled n=410,000)", "clinical_utility": "Target validation for MARC1 modulators", "tier_rank": 3 }, { "biomarker_id": "BMK-031", "name": "TM6SF2 rs58542926 genotype", "biomarker_type": "GENETIC", "pathway": "EMA-LoS", "submission_date": "2025-02-01", "decision_date": null, "status": "under_review", "context_of_use": "prognosis", "indication": "MASLD with elevated lipotoxicity risk", "population": "Adults with MASLD", "analytical_validation": "TaqMan SNP assay", "clinical_validation": "Per-allele OR 1.6 for advanced fibrosis (LITMUS n=2,310)", "clinical_utility": "Risk stratification, paradoxical lipid profile", "tier_rank": 3 }, { "biomarker_id": "BMK-032", "name": "2D-SWE (shear wave elastography, GE LOGIQ/Canon)", "biomarker_type": "IMAGING", "pathway": "EMA-LoS", "submission_date": "2024-08-12", "decision_date": "2025-11-04", "status": "letter_of_support", "context_of_use": "screening", "indication": "Liver stiffness in MASLD", "population": "Adults with metabolic risk", "analytical_validation": "Multi-vendor (GE/Canon/Philips) standardization, QIBA SWS profile", "clinical_validation": "AUROC 0.83 for F>=3 vs VCTE reference", "clinical_utility": "Point-of-care alternative to VCTE, primary care deployment", "tier_rank": 2 }, { "biomarker_id": "BMK-033", "name": "AGILE-3+ / AGILE-4 (FIB-4 + VCTE composite)", "biomarker_type": "NIT", "pathway": "EMA-QO", "submission_date": "2024-11-29", "decision_date": null, "status": "under_review", "context_of_use": "diagnosis", "indication": "Advanced fibrosis / cirrhosis MASH", "population": "Adults with MASLD", "analytical_validation": "Standardized FIB-4 + VCTE combined algorithm", "clinical_validation": "AUROC 0.87 for F>=3 (multi-center n=2,250)", "clinical_utility": "Replaces sequential testing, single-visit risk stratification", "tier_rank": 1 }, { "biomarker_id": "BMK-034", "name": "LiverFASt (Fibrotest + SteatoTest + ActiTest)", "biomarker_type": "ECM", "pathway": "EMA-LoS", "submission_date": "2023-12-15", "decision_date": "2025-07-19", "status": "letter_of_support", "context_of_use": "diagnosis", "indication": "MASLD/MASH multi-domain assessment", "population": "Adults with metabolic risk", "analytical_validation": "10-analyte serum panel, proprietary algorithm", "clinical_validation": "AUROC 0.81 (fibrosis), 0.78 (steatosis), 0.79 (activity)", "clinical_utility": "One-panel triple-domain assessment", "tier_rank": 2 }, { "biomarker_id": "BMK-035", "name": "NFS (NAFLD fibrosis score)", "biomarker_type": "NIT", "pathway": "ICH-M10", "submission_date": "2024-01-10", "decision_date": "2025-06-30", "status": "harmonized", "context_of_use": "screening", "indication": "Advanced fibrosis MASLD", "population": "Adults with metabolic risk", "analytical_validation": "Age, BMI, IFG/T2D, AST/ALT, platelets, albumin", "clinical_validation": "Dual cutoff -1.455 / 0.676, AUROC 0.81", "clinical_utility": "Primary care screening, ICH M10 harmonized", "tier_rank": 2 }, { "biomarker_id": "BMK-036", "name": "Korean-specific composite NIT (KASL panel)", "biomarker_type": "NIT", "pathway": "KFDA", "submission_date": "2025-11-08", "decision_date": null, "status": "submitted", "context_of_use": "screening", "indication": "MASLD/MASH screening in Korean adults", "population": "Korean adults with metabolic risk", "analytical_validation": "FIB-4 + ALT + adipose-derived biomarker (adiponectin/FGF21)", "clinical_validation": "AUROC 0.82 in KASL multi-center cohort n=2,140", "clinical_utility": "MFDS equivalence pathway, HIRA candidate, KASL guideline candidate", "tier_rank": 2 }, { "biomarker_id": "BMK-037", "name": "VCTE-CAP (controlled attenuation parameter)", "biomarker_type": "IMAGING", "pathway": "EMA-LoS", "submission_date": "2024-06-04", "decision_date": "2025-10-22", "status": "letter_of_support", "context_of_use": "diagnosis", "indication": "Hepatic steatosis assessment", "population": "Adults with metabolic risk", "analytical_validation": "FibroScan M/XL probe, CAP value 100-400 dB/m", "clinical_validation": "AUROC 0.82 for S>=2, cutoff 274 dB/m", "clinical_utility": "Steatosis quantification at point of care", "tier_rank": 2 }, { "biomarker_id": "BMK-038", "name": "Acoustic Radiation Force Impulse (ARFI / pSWE)", "biomarker_type": "IMAGING", "pathway": "EMA-LoS", "submission_date": "2024-04-15", "decision_date": "2025-09-10", "status": "letter_of_support", "context_of_use": "screening", "indication": "Liver stiffness in MASLD", "population": "Adults at metabolic risk", "analytical_validation": "Siemens ACUSON/Philips iU22, m/s readout", "clinical_validation": "AUROC 0.81 for F>=3", "clinical_utility": "Ultrasound-integrated point-of-care", "tier_rank": 3 }, { "biomarker_id": "BMK-039", "name": "LITMUS imaging panel (MRE + cT1 + MRI-PDFF composite)", "biomarker_type": "IMAGING", "pathway": "EMA-QO", "submission_date": "2024-10-12", "decision_date": null, "status": "under_review", "context_of_use": "staging", "indication": "MASH histology surrogate composite", "population": "Adults in MASH trials", "analytical_validation": "QIBA-harmonized multi-modal acquisition", "clinical_validation": "AUROC 0.91 for active fibrotic NASH, LITMUS imaging n=966", "clinical_utility": "Non-invasive composite endpoint candidate", "tier_rank": 1 }, { "biomarker_id": "BMK-040", "name": "Resmetirom companion diagnostic biomarker panel (MRI-PDFF + FibroScan)", "biomarker_type": "IMAGING", "pathway": "FDA-BQP", "submission_date": "2024-03-30", "decision_date": "2025-07-25", "status": "qualified", "context_of_use": "companion", "indication": "Resmetirom-treated MASH F2-F3", "population": "Adults with F2-F3 MASH on resmetirom", "analytical_validation": "Standardized MRI-PDFF + VCTE acquisition", "clinical_validation": "MAESTRO-NASH responder identification, n=966", "clinical_utility": "Companion diagnostic for THR-beta agonist therapy", "tier_rank": 1 }, { "biomarker_id": "BMK-041", "name": "FGF21 levels (response biomarker)", "biomarker_type": "ECM", "pathway": "EMA-LoS", "submission_date": "2025-01-25", "decision_date": null, "status": "under_review", "context_of_use": "monitoring", "indication": "FGF21 analog response in MASH", "population": "Adults on efruxifermin/pegozafermin", "analytical_validation": "ELISA, CV<11%", "clinical_validation": "Δ FGF21 correlates with hepatic fat reduction in HARMONY/ENLIVEN", "clinical_utility": "Pharmacodynamic biomarker for FGF21 program", "tier_rank": 2 }, { "biomarker_id": "BMK-042", "name": "Adiponectin (response biomarker)", "biomarker_type": "ECM", "pathway": "EMA-LoS", "submission_date": "2024-09-08", "decision_date": "2025-11-26", "status": "letter_of_support", "context_of_use": "monitoring", "indication": "Insulin sensitization response", "population": "Adults on PPAR agonists", "analytical_validation": "ELISA, CV<10%", "clinical_validation": "Δ adiponectin correlates with NAS improvement in NATIV3", "clinical_utility": "Pharmacodynamic biomarker for PPAR program", "tier_rank": 3 }, { "biomarker_id": "BMK-043", "name": "AI-driven EHR risk model (MASLD-PRS)", "biomarker_type": "AI-SAMD", "pathway": "FDA-BQP", "submission_date": "2025-04-22", "decision_date": null, "status": "under_review", "context_of_use": "screening", "indication": "MASLD identification from EHR", "population": "Adults in primary care", "analytical_validation": "Federated learning across 5 health systems, model card v3.0", "clinical_validation": "AUROC 0.87 external validation, calibration intercept 0.02", "clinical_utility": "Population-level case finding", "tier_rank": 2 }, { "biomarker_id": "BMK-044", "name": "Apolipoprotein F (ApoF) - emerging serum biomarker", "biomarker_type": "ECM", "pathway": "DDTII", "submission_date": "2025-05-09", "decision_date": null, "status": "workshop_discussion", "context_of_use": "diagnosis", "indication": "MASH lipotoxicity surrogate", "population": "Adults with MASLD", "analytical_validation": "Aptamer-based proteomics (SomaScan)", "clinical_validation": "AUROC 0.78 in pilot n=320", "clinical_utility": "DDTII discovery-stage biomarker", "tier_rank": 3 }, { "biomarker_id": "BMK-045", "name": "Multi-omics fingerprint (proteomics + metabolomics + lipidomics)", "biomarker_type": "ECM", "pathway": "DDTII", "submission_date": "2025-03-28", "decision_date": null, "status": "workshop_discussion", "context_of_use": "prognosis", "indication": "MASH progression signature", "population": "Adults in LITMUS multi-omics arm", "analytical_validation": "Multi-platform integration (SomaScan + Metabolon + Lipotype)", "clinical_validation": "C-index 0.77 for fibrosis progression at 2y", "clinical_utility": "DDTII early discovery; not regulatory grade yet", "tier_rank": 3 }, { "biomarker_id": "BMK-046", "name": "Spleen stiffness (VCTE/MRE)", "biomarker_type": "IMAGING", "pathway": "EMA-LoS", "submission_date": "2025-02-19", "decision_date": null, "status": "under_review", "context_of_use": "prognosis", "indication": "Portal hypertension surrogate in MASH", "population": "Adults with compensated MASH cirrhosis", "analytical_validation": "Dedicated 100Hz spleen probe (VCTE) or MRE", "clinical_validation": "AUROC 0.84 for CSPH, Baveno VII context", "clinical_utility": "Non-invasive portal hypertension assessment", "tier_rank": 2 }, { "biomarker_id": "BMK-047", "name": "T2D-MASLD composite risk score (HbA1c + FIB-4 + VAT)", "biomarker_type": "NIT", "pathway": "CTTI", "submission_date": "2024-12-11", "decision_date": "2025-12-20", "status": "consensus_published", "context_of_use": "screening", "indication": "MASLD case finding in T2D clinics", "population": "Adults with T2D", "analytical_validation": "Standard chemistry + bioimpedance VAT estimate", "clinical_validation": "AUROC 0.82 in KDA/ADA pooled cohort", "clinical_utility": "T2D clinic screening, CTTI working group endorsed", "tier_rank": 2 }, { "biomarker_id": "BMK-048", "name": "Korean PNPLA3 GG homozygote risk panel", "biomarker_type": "GENETIC", "pathway": "KFDA", "submission_date": "2025-08-29", "decision_date": null, "status": "submitted", "context_of_use": "prognosis", "indication": "MASLD progression in Korean carriers", "population": "Korean adults with PNPLA3 GG genotype", "analytical_validation": "Korean reference panel, allele frequency 0.47", "clinical_validation": "C-index 0.71 for fibrosis progression in KASL cohort", "clinical_utility": "MFDS class II IVD candidate, KASL guideline alignment", "tier_rank": 2 } ] }