Major international studies identify accurate non-invasive tests for metabolic liver disease

Major international studies from the LITMUS program published in October 2026 validate accurate non-invasive blood, imaging, and elastography tests for metabolic dysfunction-associated steatotic liver disease, aiming to replace invasive biopsies. Concurrently, Singapore's Mirxes and NCCS launched CIRRHOClear, a microRNA blood test achieving 89% diagnostic accuracy for early cirrhosis risk.

Overview of the LITMUS studies

• ▪The companion LITMUS Imaging Study published in Nature Medicine evaluated MRI and elastography techniques in more than 350 patients.
• ▪The LITMUS program brought together 53 international academic and industry partners funded through the European Innovative Medicines Initiative 2 Joint Undertaking.
• ▪The main LITMUS study published in The Lancet evaluated blood tests and ultrasound liver stiffness measurements across more than 1,500 patients.
• ▪Two LITMUS program studies published in October 2026 in The Lancet and Nature Medicine evaluated non-invasive tests for diagnosing MASLD and MASH to reduce reliance on liver biopsies.

Accuracy of LITMUS blood and proteomic tests

• ▪For identifying at-risk MASH in LITMUS trials, only the SOMAScan proteomic panel met the predefined diagnostic accuracy threshold.
• ▪In LITMUS study results, the SOMAScan proteomic panel, ELF blood test, and ADAPT blood test exceeded accuracy performance thresholds for detecting liver cirrhosis.

Diagnostic performance of elastography and MRI

• ▪FibroScan-based elastography tools, including the Agile 3+ score, achieved high diagnostic accuracy for advanced liver fibrosis and cirrhosis in LITMUS trials.
• ▪In the LITMUS Imaging Study, magnetic resonance elastography outperformed FibroScan-based liver stiffness measurements in detecting advanced liver fibrosis and cirrhosis.

Gamma-GT assessment and proposed diagnostic pathway

• ▪LITMUS researchers proposed a diagnostic pathway using gamma-GT for initial screening, followed by ELF or FibroScan testing, reserving advanced MRI for specialist care.
• ▪In LITMUS evaluations, a gamma-GT blood test outperformed the widely used FIB-4 score as a first-line assessment tool for liver disease.

Launch and validation of CIRRHOClear

• ▪CIRRHOClear was developed using data from the four-year ELEGANCE study of 2,000 liver disease participants led by the National Cancer Centre Singapore.
• ▪In clinical validation studies, CIRRHOClear accurately identified liver cirrhosis risk in 89% of cases and correctly ruled out the condition 95% of the time.
• ▪Mirxes and the National Cancer Centre Singapore launched CIRRHOClear, a microRNA blood test designed to evaluate liver cirrhosis risk

Prevalence and demand for non-invasive tests

• ▪Metabolic dysfunction-associated steatotic liver disease (MASLD) affects up to one in three adults worldwide and up to seven in 10 people with obesity or type 2 diabetes.
• ▪Demand for accurate non-invasive liver diagnostics is growing as the first licensed drug treatments for MASH enter clinical practice.