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.