From Validation to Implementation: Scaling NITs in MASLD Care, With Zobair Younossi, MD, MPH

As the prevalence of metabolic dysfunction-associated steatotic liver disease (MASLD) continues to climb in parallel with obesity and type 2 diabetes, clinicians face a pressing question regarding how at-risk patients should be identified and managed in routine practice.

Although noninvasive tests (NITs) have been validated for fibrosis risk stratification and are increasingly incorporated into society guidelines, their adoption remains inconsistent across care settings. At the same time, therapeutic options for metabolic dysfunction-associated steatohepatitis (MASH) are expanding, raising the stakes for early and accurate case finding. Against this backdrop, the conversation is shifting from whether to use noninvasive testing to how quickly and broadly it should be implemented and what barriers must be addressed to make risk-based MASLD care a standard part of clinical workflows.

In an interview with HCPLive, Zobair Younossi, MD, MPH, professor and chairman of the Global NASH Council, makes a clear and urgent case that the time to implement NIT-based risk stratification for MASLD is now.

Check out part 1 of the interview with Younossi here.

While no test is perfect, he argues the data are sufficiently strong to support widespread adoption across clinical settings, most recently from his trio of sequentially published papers on how NITs perform across regions, how well they predict liver-related outcomes compared with biopsy, and how their accuracy varies in key subgroups.

“I think we should adopt it now,” Younossi said. “The data is not perfect, but it's pretty good, and these tests should be adopted in every clinical practice.”

He stresses that waiting for a flawless diagnostic tool risks further delay in addressing a disease that is already a leading cause of liver transplantation and hepatocellular carcinoma in the United States. Instead, he calls for implementation across primary care, endocrinology, diabetology, gastroenterology, and hepatology. MASLD, he notes, should be viewed similarly to other diabetes-related complications. Just as clinicians routinely screen for retinopathy and nephropathy, liver risk assessment should become standard practice in patients with metabolic disease.

At the same time, he notes that important gaps remain. While current NITs are highly effective for identifying advanced fibrosis, they are less precise in detecting patients with earlier yet clinically meaningful stage 2 (F2) fibrosis. Younossi points to ongoing work leveraging large datasets, machine learning, and artificial intelligence to develop more refined combination algorithms and calls for a paradigm shift in drug development. With NITs now guiding real-world clinical decisions, he argues that clinical trials should move away from mandatory biopsy-based enrollment and instead transition toward NIT-based designs that better reflect contemporary practice.

He also notes that barriers to adoption extend beyond diagnostics, with awareness remaining a major challenge requiring education at multiple levels: provider, public health policy, and global health leadership.

“I think in the next 5 years, you'll see additional drugs and more help for patients with progressive MASH,” Younossi said. “In that context, I think it’s going to be very important that we identify those patients, we develop care pathways where we connect these patients who are at risk with a care provider that will not only give them advice and properly manage their cardiometabolic risks with diet, exercise, and also the medication that we have available for diabetes and hypertension, but also, if they are candidates for treatment with MASH drugs, that they're offered. We'll have more drugs in the pipeline, and hopefully we'll have patients ready by then.”

Editors’ Note: Younossi reports relevant disclosures with Intercept, Cymabay, Boehringer Ingelheim, Ipsen, BMS, GSK, Novo Nordisk, Siemens, Madridgal, Merck, Aligos, Akero, Sanofi and Abbott.

Reference

Younossi ZM, de Avila L, Petta S, et al. Diagnostic Accuracy of Non-Invasive Tests for MASLD Across Age, Type 2 Diabetes, and Obesity Subgroups: A Multinational Study. Clin Gastroenterol Hepatol. Published online January 28, 2026. doi:10.1016/j.cgh.2026.01.016