Liver blood tests match biopsy for cirrhosis, fall short for early MASH in 1,590-patient study

Overview

Updated 2 hours ago

For years, the only dependable way to grade fatty liver disease has been a needle biopsy: a painful, costly procedure that samples a fraction of the organ. A study of 1,590 patients across 13 countries, published in The Lancet, tested 30 blood and imaging markers against that needle. For cirrhosis and advanced scarring, several matched it. For the earliest stage that drugmakers most want to treat, only one did.

The gap matters because regulators and trial sponsors still require biopsy confirmation of at-risk MASH before enrolling patients. If a blood test could replace that step, trials would get cheaper and faster, and patients in primary care could be sorted without a specialist procedure. The study suggests that future is close for fibrosis, and not yet here for early disease.

Why it matters

A validated blood test for liver scarring could spare many patients a biopsy, but the earliest, most-treated stage still has no replacement.

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Key Indicators

1,590

Participants with centrally scored biopsies

Adults with biopsy-confirmed MASLD recruited across 13 countries.

Biomarkers tested

12 single markers and 18 multimarker panels compared against histology.

0.83

SomaSignal accuracy for at-risk MASH

Area under the curve; the only test to clear the study's 0.80 threshold for this target.

0.92

SomaSignal accuracy for advanced fibrosis

Highest of any test for scarring at stage F3 or worse.

0.80

Minimum acceptable accuracy threshold

The study's bar for a test that could potentially replace biopsy.

Countries represented

Recruitment spanned Europe and the United States at 37 liver centers.

Voices

Curated perspectives — historical figures and your fellow readers.

People Involved

Yasaman Vali

Lead author, LITMUS diagnostic accuracy study

Researcher with the LITMUS consortium

Detlef Schuppan

Director, Institute of Translational Immunology, University Medical Center Mainz

Co-developer of the TSP2 blood marker

Jörn Schattenberg

Former head, Metabolic Liver Diseases Division, Mainz

Co-investigator on TSP2 development

Organizations Involved

LITMUS consortium

Research consortium

Ran the diagnostic accuracy study

A European public-private effort testing non-invasive biomarkers for fatty liver disease.

Newcastle University

University

Announced the results

UK university whose press office publicized the LITMUS findings.

University Medical Center Mainz

Academic medical center

Developed the TSP2 marker

German hospital whose researchers developed a blood marker for liver fibrosis.

The Lancet

Medical journal

Published the main study

British medical journal that published the LITMUS diagnostic accuracy study.

Timeline

January 2018 October 2026

5 events Latest: 2 days ago

Tap a bar to jump to that date

October 2026
Lancet publishes LITMUS diagnostic accuracy study
Latest Publication

SomaSignal is the only test to clear the accuracy bar for at-risk MASH.
2 days ago
Companion imaging study appears in Nature Medicine
Publication

MRI elastography and Agile scores clear the bar for cirrhosis in 357 patients.
2 days ago
Newcastle University announces results
Statement

Press office says non-invasive tests can reduce the need for biopsy.
4 days ago
June 2023
Recruitment closes with 1,590 biopsied participants
Study

Final cohort includes 609 patients with at-risk MASH and 164 with cirrhosis.
June 30th, 2023
January 2018
LITMUS begins recruiting patients
Study

Enrollment opens across Europe and the United States for a prospective diagnostic accuracy study.
January 1st, 2018

Scenarios

A blood panel replaces biopsy for staging advanced fibrosis

Possible Resolves by End of 2027

Discussed by: LITMUS authors and Newcastle University

SomaSignal and FibroMeter-VCTE cleared the study's 0.80 accuracy bar for advanced fibrosis and cirrhosis. If a regulator or major guideline body accepts one, it could enter routine hepatology practice. The trigger is a formal recommendation or a drug-label change.

Biopsy stays mandatory for at-risk MASH trial enrollment

Likely Resolves by Q2 2027

Discussed by: LITMUS authors and Nature Medicine commentary

Only SomaSignal met the accuracy threshold for at-risk MASH, and the study did not report cut-offs or sensitivity. Regulators require biopsy confirmation for late-stage trial entry. Without a second validated test, that requirement is unlikely to change.

A GGT-first two-step pathway enters primary care guidance

Possible Resolves by End of 2027

Discussed by: LITMUS authors and Newcastle University

The study found sequential two-step approaches using gamma-glutamyl transferase as a first-line test met the accuracy bar for both advanced fibrosis and at-risk MASH. Newcastle described a simplified pathway: GGT first, then ELF or FibroScan, with imaging reserved for specialists.

Historical Context

2 moments from history that rhyme with this story — and how they unfolded.

2003

Transient elastography reaches liver clinics (2003)

Echosens introduced FibroScan, an ultrasound device that measures liver stiffness as a proxy for scarring. It offered the first widely used non-invasive alternative to biopsy for staging fibrosis.

Then

Hepatology societies began recommending elastography alongside biopsy.

Now

FibroScan became standard in liver clinics, but it performs poorly at distinguishing early inflammation.

Why this matters now

The LITMUS results repeat the pattern: elastography and composite scores are strong for advanced fibrosis and cirrhosis, weak for early disease.

2005