Routinely Available Noninvasive Tests Perform Well in Identifying Patients with Advanced Fibrosis Due to NASH: Data from the TARGET-NASH Observational Cohort.

Challenge

While NITs had shown promise in clinical trial populations for identifying advanced fibrosis in NASH, their performance in real-world clinical practice—where patients are more heterogeneous and data quality varies—had not been validated, limiting confidence in their use for trial enrichment.

Solution

The TARGET-NASH cohort was used to evaluate FIB-4, NFS, and VCTE against locally interpreted liver biopsies, reporting AUROC, sensitivity, specificity, and PPV/NPV for advanced fibrosis across the real-world population, with subgroup analyses by demographics and clinical variables.

Impact

Demonstrating that NITs perform comparably in real-world practice to their performance in clinical trial populations validates their use for NASH trial enrollment enrichment, supporting sponsors in designing biopsy-sparing enrichment strategies acceptable to regulators.