NASH Clinical Trials

Cytokeratin 18 (CK18 and ccK18):
Non-invasive biomarkers for assessing hepatocyte apoptosis and necrosis

Biomarker Utility in NASH Studies Available Assays Catalog #
Total CK18 (M65®) Biomarker for hepatocyte cell death (apoptosis and necrosis) M65® ELISA P10020
M65® EpiDeath ELISA P10040
caspase-cleaved CK18
Biomarker for hepatocyte apoptosis M30® Apoptosense ELISA P10011


The Problem:

In early phase NASH trials, performing liver biopsies to evaluate the effect of a potential drug candidate is not always practical or feasible.

  • These relatively short-duration early trials may not result in significant changes in liver histology.
  • Traditional non-invasive biomarkers for NASH, such as serum ALT and AST levels, are notoriously insensitive and non-specific, and do not always accurately reflect the extent of liver injury.

The Solution: 

Non-Invasive, mechanistic biomarkers that are reflective and predictive of changes in liver histology

  • Serum CK18 (M65®) and ccK18 (M30®) measure hepatocyte apoptosis and necrosis.
  • Apoptosis and necrosis are underlying mechanisms that are directly involved in the pathogenesis of NAFLD
  • Changes in CK18 and ccK18 levels may therefore be early indicators for changes in disease activity in response to drug treatment.
  • Changes in serum CK18 and ccK18 levels have been shown to correlate with histological changes in the liver.

Additional NASH Biomarker ELISAs from DiaPharma

DiaPharma offers additional non-invasive biomarker assays for NAFLD/NASH.

Incorporating these biomarkers into your research adds valuable information about changes in disease activity, which could decrease time and costs of studies.

M30® and M65® Cytokeratin 18 (CK18)ELISAs


Mac-2 Binding Protein





are just a few of the biomarker assays offered by DiaPharma to help your drug candidate move forward.

If you’d like to speak with an expert about which biomarker would be most useful for your project, call 800.447.3846 or email us today.

For research use only in the U.S. and Canada. Not for use in diagnostic procedures.