This study evaluated the diagnostic performance of non-invasive tests (NITs) like the FibroScan-AST (FAST) score, LSM-VCTE, FIB-4, and NFS for screening metabolic dysfunction-associated steatohepatitis (MASH) in clinical trials. Data from 8045 participants were analyzed to assess both single NITs and sequential NIT combinations for detecting MASH+F2-4 and MASH+F4. The study found that sequential combinations of FIB-4 with LSM-VCTE or FAST provided similar diagnostic performance to LSM-VCTE alone, with the advantage of needing fewer LSM-VCTE scans, potentially reducing healthcare costs while maintaining sensitivity and improving efficiency.

While individual NITs like FAST and LSM-VCTE showed moderate accuracy, using FIB-4 or NFS followed by LSM-VCTE or FAST reduced screen failure rates (SFR) and the need for biopsies. Screening for MASH+F2-3 and MASH+F4 with specific NIT thresholds led to modest improvements in SFR, suggesting a strategy that reduces resource use in clinical trials. Subgroup analyses showed that BMI and type 2 diabetes (T2DM) impacted the performance of some NITs. Overall, sequential NIT screening appears to be an effective strategy for identifying at-risk patients while optimizing resources, especially in clinical trials.

Reference: Mózes FE, Lee JA, Vali Y, et al. Diagnostic accuracy of non-invasive tests to screen for at-risk MASH-An individual participant data meta-analysis. Liver Int. 2024 Aug;44(8):1872-1885. doi: 10.1111/liv.15914. Epub 2024 Apr 4. PMID: 38573034.