Biomarker for Liver Cancer

A new test system is designed to determine the risk of developing liver cancer in patients with chronic liver diseases (CLD). The system has been cleared by the U.S. Food and Drug Administration (FDA).

Hepatocellular carcinoma (HCC) is the fourth most common cancer in the world today and the third most common cause of cancer-related death. Risk factors include chronic hepatitis caused by the hepatitis B or C virus and liver cirrhosis. The clinical effectiveness of screening and surveillance depends on establishing early diagnosis, provided that effective treatments are available.

The new test employs human alphafeta protein (AFP), a glycoprotein. AFP-L3 appears to be only produced by cancer cells in the liver of diseased patients. A multi-center, prospective, double-blinded, longitudinal clinical study of the test was conducted in Canada and the United States. This revealed that patients with elevated AFP-L3% (10% or more) were associated with a seven-fold increase in the risk of developing HCC within the next 21 months. These patients should be intensely evaluated for evidence of HCC, according to the existing HCC practice guidelines on oncology.

The new test system was developed by Wako Diagnostics, a division of Wako Chemicals USA (Richmond, VA, USA). The company's AFP-L3 is a reagent for the quantitative determination of AFP-L3% based on a liquid-phase binding assay. This method uses a liquid-phase binding reaction between the antigen and antibody, and separates bound and free forms by column chromatography without the need for a solid phase. Wako's automated analyzer, LiBASys, reports to a doctor both the total AFP and AFP-L3% result simultaneously.




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