MetaSight

PIPELINE: MASH-Fibrosis

MASH-Fib™ Liquid Biopsy

A blood-test for diagnosing and monitoring metabolic dysfunction-associated steatohepatitis (MASH)-fibrosis

  • Liver fibrosis in patients with MASH is strongly associated with overall and disease-specific mortality.
  • Diagnosing MASH-fibrosis supports drug subscription; for example, with Madrigal’s Rezdiffra.
  • Liver biopsy - the current gold standard for diagnosis and monitoring is invasive, risky, and costly.

INTENDED USE

Diagnosing MASH with significant or advanced fibrosis (≥ F2/F3) in high-risk MASLD patients (T2D, metabolic syndrome, or FIB-4 > 1.3) for prescription of drugs and response monitoring.

THE TECHNOLOGY

Proteomics analysis of 3 novel serum biomarkers associated with liver fibrosis and inflammation.

  • Available for Research Use Only
  • Launching as CLIA/LDT in US in 2025

Publications: EASL’23; AASLD’23: JL. Calleja, J. Cresop,…, S. Francque; AASLD’24: S. Shaham-Niv,…, A. J. Sanyal

Superior DIAGNOSTIC performance compared to existing non-invasive tests

Validated via ~2,000 samples from 6 cohorts with different clinical settings and geographical origins:

  • Secondary and tertiary care centers
  • Clinical trial
  • Real-world prospective screening

63% higher sensitivity than FAST (FibroScan)3

66% higher sensitivity than ELF4

Enables MONITORING patient response to treatment

Post-hoc analysis of a Phase 2b clinical trial (EMMINENCE) by Cirius Therapeutics with baseline and end-of-treatment biopsies

High performance in fibrosis monitoring, where ELF fails

1,2 Assuming a prevalence of 20%-40% and 10%- 20% for significant and advanced fibrosis in hepatology care, respectively; 3 detecting significant fibrosis; 4 detecting advanced fibrosis