DAY 2: Non-Invasive Tools Provide New Options for Detecting Fibrosis in Clinical Practice

Non-invasive tests (NITs) may facilitate screening and staging of hepatic fibrosis in clinical practice, enabling providers to monitor progression of metabolic dysfunction-associated steatohepatitis (MASH) without the use of invasive liver biopsies, according to a meta-analysis featured at the 2025 Annual Scientific Meeting of the American College of Gastroenterology in Phoenix, Arizona.

While liver biopsy is considered the gold standard for staging fibrosis in MASH, its use is limited by its invasive nature, high associated costs, and potential for complications. Because of these limitations, several non-invasive tests, including vibration-controlled transient elastography (VCTE), enhanced liver fibrosis (ELF) score, Fibrosis-4 (FIB-4) index, and the FibroScan-AST (FAST) score, have emerged as alternative modalities for staging fibrosis and monitoring the progression of disease in adults with MASH. These modalities, which rely on blood tests, elastography, or a combination of these tools, are typically more cost-effective and easier to perform in a routine clinical setting compared to liver biopsy.

The scarcity of data regarding the diagnostic accuracy of different NITs prompted researchers at St. Mary's General Hospital in Passaic, New Jersey to design a study aimed at comparing the accuracy of various noninvasive modalities in identifying clinically significant fibrosis (at least stage F2) among adults with biopsy-confirmed MASH. After performing comprehensive literature searches in multiple databases, the researchers selected 28 studies that evaluated one or several NITs used for detecting and staging fibrosis in adults with biopsy-confirmed MASH. 

Overall, non-invasive tests had a pooled sensitivity of 84% and a pooled specificity of 82%, corresponding to an area under the ROC curve (AUC) of 0.89 across all 28 studies. Prospective studies and those with a low risk of bias provided the most reliable data, as reflected in the slightly higher sensitivity and AUC values. VCTE demonstrated the most consistent diagnostic performance (AUC ~0.90), followed by the ELF score and the FAST score, which demonstrated a comparable performance (AUC 0.84–0.87) in studies with a low risk of bias. The FAST score is a noninvasive tool that combines data from VCTE (FibroScan) and aspartate transaminase (AST) blood tests to assess fibrosis. In contrast, the FIB-4 index exhibited lower and more variable accuracy, particularly in studies with retrospective designs and in non-U.S. cohorts. The FIB-4 index is a non-invasive blood test used to estimate the risk of advanced liver fibrosis by using a formula that includes the patient's age and laboratory values for AST, alanine transaminase (ALT), and platelet count. A low score (<1.45) suggests a low risk for advanced fibrosis, while a high score (>3.25) indicates a high risk that should prompt further evaluation.

“In light of the increasing burden of MASH in the United States and the pressing need for scalable alternatives to liver biopsy, this analysis advances efforts to validate non-invasive fibrosis assessment tools in hepatology practice,” the authors noted. “VCTE, ELF, and other NITs demonstrated strong diagnostic performance for the detection of clinically significant fibrosis. These findings highlight the clinical utility of non-invasive tests for detecting and staging fibrosis in MASH, with VCTE emerging as the most reliable modality across diverse study settings.”

Lead author Nayanika Tummala, MBBS, a resident at St. Mary's General Hospital, noted that these findings are a first step toward the increased uptake of NITs, particularly VCTE, in routine clinical practice. The selection of NIT modality depends on patient profiles, epidemiological factors, and comorbidities. Cost, availability of tests, and institutional protocols may also influence choice of modality. While further research is needed to validate these tools across diverse populations and clinical settings, providers now have more tools at their disposal for identifying high-risk patients with significant liver damage who need intervention.