As a preeminent contract antibody development company, Creative Biolabs offers high-quality in vitro diagnostic (IVD) antibody development services targeting a wide range of biomarkers. Here, we focus on the CK-18 M30 marker of liver failure. We are committed to providing the highest quality of custom services and products at the most reasonable prices.

Cytokeratin 18 Neoepitope M30 (CK-18 M30)

Chronic hepatitis B (CHB) infection is one of the most common causes of chronic liver disease worldwide. In CHB infection, liver histology may be normal, mild or moderately damaged, or cirrhotic. A serious increase in liver fibrosis is observed in the advanced stages of the disease. Serum apoptotic cytokeratin 18 neoepitope M30 (CK-18 M30) is among the popular noninvasive markers used to detect liver fibrosis. Hepatocyte apoptosis can be initiated by different complex pathways, most of which involve activation of the caspases. CK-18 is a major intermediate filament protein in liver cells and one of the most prominent substrates of caspases during hepatocyte apoptosis. CK-18 M30, which is coded between the 387, 396th position of CK-18 is produced by caspase system activation and accepted as an apoptosis marker. Altered degradation and increased synthesis of extracellular matrix (ECM) proteins are implicated in liver fibrosis.

The M30-Apoptosense ELISA assay uses antibody M30, which detects a neo-epitope of CK18 formed after caspase cleavage at Asp396. The M65-ELISA assay will detect all CK18 fragments that contain epitopes in the 300 to 390 amino acid region of the protein. Fig.1 CK18 is cleaved at Asp238 and Asp396 by caspases during apoptosis. (Olofsson, MH., 2007)

CK-18 M30 Marker of Liver Failure

CK-18 M30 has been a popular marker for detecting liver fibrosis in recent years. It becomes available at an early caspase cleavage event during apoptosis and has been regarded as a biochemical marker of liver injury.

Serum M30 levels is a potential biomarker of severe liver disease in nonalcoholic fatty liver disease (NAFLD) and normal aminotransferase levels. It has also been identified as a useful marker associated with increased severity of fibrosis and inflammation in chronic hepatitis C (CHC) and nonalcoholic fatty liver disease (NAFLD).

M-30 antigens are at least 10-fold greater in acute liver failure (ALF) patients compared to patients with chronic HCV or normal controls. Levels of the liver-specific apoptosis marker M-30 antigen were significantly higher in patients who died or needed liver transplantation than those who survived spontaneously.

CK-18 neoepitope (M30 antigen) levels are significantly increased in the serum of NASH patients in comparison to patients with SS and controls. Fig.2 CK-18 neoepitope (M30 antigen) levels are significantly increased in the serum of NASH patients in comparison to patients with SS and controls. (Yaman, E., 2010)

IVD Antibody Development Services for CK-18 M30 Marker

In order to render more precise antibody-based diagnostic tools and assist clinicians in the diagnosis, prognosis, and staging of different diseases and infections, Creative Biolabs provides customized IVD antibody development services to generate high-quality antibodies for diagnostic usage. Besides antibody generation, we also offer antibody conjugation, antibody pairing, and diagnostic immunoassay development services to our clients.

For more detailed information, please feel free to contact us or directly send us an inquiry.


  1. Yaman, E., (2010). “Serum M30 levels are associated with survival in advanced gastric carcinoma patients.” Int Immunopharmacol 10(7): 719-722.
  2. Olofsson, MH., (2007). “Cytokeratin-18 is a useful serum biomarker for early determination of response of breast carcinomas to chemotherapy.” Clin Cancer Res 13(11): 3198-3206.

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