Design: Prospective, multicentre diagnostic accuracy study
Population: 1590 adults with biopsy-confirmed MASLD in Europe and the USA
Primary outcome: AUC against central histology for MASH, at-risk MASH, advanced fibrosis and cirrhosis
Effect: Advanced fibrosis: best AUC 0.92 (0.90–0.94); cirrhosis: 0.94 (0.90–0.97); at-risk MASH: 0.83 (0.80–0.85)

LITMUS, published in the Lancet on 31 October, compared 12 single markers and 18 multimarker panels against centrally read liver biopsy in 1590 adults with metabolic dysfunction-associated steatotic liver disease (MASLD) across 13 countries. A test needed an area under the curve (AUC) above 0.80 to be considered a possible substitute for biopsy.

For advanced fibrosis, the best panels reached AUCs of 0.84 to 0.92, with a proteomic panel highest. For cirrhosis, a panel combining blood tests with elastography reached 0.94. For at-risk steatohepatitis, only the proteomic panel met the threshold. A two-step approach starting with gamma-glutamyl transferase also met it for advanced fibrosis and at-risk disease.

This matters because drug treatments for steatohepatitis now exist and need a way to choose patients without biopsy. Most of the top-performing panels are proprietary and not widely available, including in India. Simple scores and elastography remain the practical tools.

The population was referred and biopsied, so it had more advanced disease than a primary care clinic, which flatters diagnostic accuracy.

Single blood markers are weak at detecting at-risk steatohepatitis; do not rely on one test.
Combined blood-and-elastography panels performed best for cirrhosis.
Many top-performing panels are proprietary and not widely available.
Use a stepwise approach: a simple score first, then elastography or a panel for those not ruled out.

Why it matters

With licensed treatments for steatohepatitis, choosing who to treat without biopsy is now a practical question.

The statistics, in plain English

AUC measures how well a test separates people with and without a condition: 0.5 is a coin toss, 1.0 perfect. An AUC of 0.92 (0.90 to 0.94) is strong. But accuracy measured in a biopsied, specialist-referred group is usually higher than in a general clinic.