Diagnostic Performance of LIVERFASt as a Non-invasive Liver Fibrosis Test: Data from Three Cohorts of Patients with Metabolic Dysfunction-associated Steatotic Liver Disease

Year: 2025

Type: article

Abstract: AIM: This study evaluates the diagnostic performance of the novel blood-based device, LIVERFASt to detect fibrosis stages in patients with metabolic dysfunction-associated steatotic liver disease (MASLD), including those with type 2 diabetes (T2DM), compared to FIB-4 in a subgroup analysis. METHODS: LIVERFASt is computed with 10 blood biomarkers and four anthropometric measures and provides a quantitative score (0.00-1.00) to stage cirrhosis (F4), advanced fibrosis (≥F3), and clinically significant fibrosis (≥F2). Three cohorts of patients (two retrospective and one prospective) from tertiary centers in Europe and the U.S. with histological-proven biopsy were used to assess LIVERFASt and FIB-4 diagnostic performance using area under the receiver operating curve (AUROC), sensitivity (Sn), specificity, and predictive values (PV) for varying fibrosis prevalence levels. RESULTS: 497 MASLD adult patients were included (median age 56 years, 56.7% female, 50.3% T2DM, 44.1% advanced fibrosis, and 20.1% cirrhosis). In the pooled analysis, the AUROCs for fibrosis stages F4, ≥F3, and ≥F2 were: 0.868, 0.846, 0.748, as well as for the T2DM subgroup (n=250): 0.846, 0.798, 0.736, respectively. For 35% advanced fibrosis prevalence, the positive/negative PVs were 77.2%/81.3% for the overall cohort and 65.52%/79.81% for the subgroup with tT2DM, respectively. At high (90%) to low (1%) advanced fibrosis prevalences, the positive and negative PVs ranged from 93% to 4.28% and from 43.06% to 99.73%, respectively. For F4 and ≥F3 fibrosis stages, LIVERFASt outperformed FIB-4: AUROC 0.870 vs 0.851 and 0.874 vs 0.821 (p<0.01), with Sn 74.07 vs 48.15 and 65.54 vs 37.29, respectively. CONCLUSIONS: LIVERFASt is a highly sensitive and clinically useful diagnostic test for staging fibrosis in MASLD patients, including those with T2DM and has a higher Sn for detecting advanced fibrosis when compared with FIB-4.

Source: Journal of Gastrointestinal and Liver Diseases

DOI: 10.15403/jgld-6432

Institutions: Arizona Liver Health, Methodist Dallas Medical Center, Henry Ford Health, Wayne State University, Henry Ford Hospital, Pinnacle Clinical Research, Ohio Gastroenterology and Liver Institute, Baylor College of Medicine, Northwell Health, Hofstra University, Donald & Barbara Zucker School of Medicine at Hofstra/Northwell, Texas Digestive Disease Consultants, Doctors Hospital at Renaissance, Houston Methodist, Saint Louis University, Quality Research, Centre Hospitalier Universitaire de Bordeaux, Université de Bordeaux, Cincinnati Children's Hospital Medical Center, University of Washington, ObvioHealth (United States), National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Sorbonne Université, Assistance Publique – Hôpitaux de Paris, Pitié-Salpêtrière Hospital, Centre National de la Recherche Scientifique, Inserm, Unité de Technologies Chimiques et Biologiques pour la Santé, Texas Tech University, Texas Tech University Health Sciences Center, Icahn School of Medicine at Mount Sinai, Queen Mary University of London, Blizard Institute, Virginia Commonwealth University, Virginia Commonwealth University Medical Center

Language: English

Topic: Liver Disease Diagnosis and Treatment

Subfield: Epidemiology

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: diamond

Funders: AstraZeneca, Gilead Sciences, Eisai, Novo Nordisk, Université de Bordeaux, Ipsen, Sirtex Medical, Genentech, National Institute of Diabetes and Digestive and Kidney Diseases

OpenAlex ID: W7117302463