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 (ccK18/M30®) |
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 diapharma.com for our full panel of assays.
Research use only in the U.S. and Canada. Not for use in diagnostic procedures.
Over 20 years of scientific expertise,
with support just a call or click away.
Visit diapharma.com |
Diapharma Group, Inc. 8948 Beckett Rd, West Chester, OH 45069
ML-00-00637Rev01