Biomarker Assays for NASH Clinical Trials

Posted: June 24, 2020

Biomarker Assays for NASH Clinical Trials

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


Biomarker Utility in NASH Clinical Trials Available Assay 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
  • CK18 and ccK18 have been used as secondary endpoints in over 60 NAFLD/NASH clinical trials to assess efficacy of new therapeutics
  • Mechanistic biomarkers: Hepatocyte apoptosis and necrosis are underlying mechanisms involved in the pathogenesis of NAFLD. Changes in CK18 and ccK18 may reflect changes in disease activity in study subjects in response to drug therapy
  • More specific for liver than ALT & AST
  • Sensitive: Depending on mechanism of action of the drug, changes can be observed within weeks, or even hours
  • Non-invasive: Changes in serum CK18 and ccK18 have been shown to correlate with changes in liver histology (ballooning, inflammation, and fibrosis)
  • CK18 can be used as a prescreening tool to reduce screen failure rates by helping to identify study subjects with a NAS ≥ 4


Additional NASH Biomarker ELISAs from Diapharma

Collagen IV L-FABP FGF-19 FGF-21 Fibronectin hsCRP Mac-2-BP Noggin NGAL Osteopontin PAI-1 sCD163

And more! Visit for our full panel of assays.


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


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