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Posted: January 19, 2021
Biomarker Assays for NASH Clinical Trials
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Non-invasive biomarkers are becoming more and more prominent in research and clinical trials of potential new drugs for Non-alcoholic fatty liver disease (NAFLD)/Nonalcoholic steatohepatitis (NASH) and Alcoholic Liver Disease (ALD)/Alcoholic Hepatitis (AH).
Key changes in these plasma biomarkers could reduce the frequency of biopsies in clinical trials, give an early indication of the efficacy of potential new therapies in development, and provide mechanistic information about a drug’s action in NASH and AH subjects.
These biomarkers mean simpler assays using easily obtainable samples, and they can provide supplementary information to ALT and AST data, where there can be significant overlap in levels among subjects with or without disease.
One of the most prominent biomarkers is Keratin 18 (K18/CK18). Circulating CK18 levels are reflective of hepatocyte cell death. The M30® Apoptosense and M65® ELISAs detect caspase-cleaved CK18 and total CK18, respectively, and allow for discrimination between apoptotic and necrotic cell death modes.
DiaPharma offers additional non-invasive biomarker assays for NAFLD/NASH, AH, and DILI research. 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, Osteopontin, Mac-2 Binding Protein, sCD163, and L-FABP 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.
Research use only in the U.S. and Canada. Not for use in diagnostic procedures.
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