一種新型檢測系統被設計用于確定慢性肝臟疾病患者患肝癌的風險。這套系統已經獲得美國食品藥品管理局的許可。
在世界范圍內，肝細胞癌是第四種最常見的癌癥，第三種最常見的癌癥相關死亡原因。危險因素包括由乙型肝炎病毒和丙型肝炎病毒導致的慢性肝炎和肝硬化。篩查和普查的臨床效率依賴于早期診斷，如果想要得到有效治療的話。
這種新型檢測方法使用人甲胎球蛋白(AFP)，這是一種糖蛋白。AFP-L3是唯一由得病患者肝臟中癌細胞生成蛋白。在加拿大和美國的一項多中心、前瞻性、雙盲、長期臨床試驗中，對該檢測方法進行了研究。結果顯示AFP-L3%升高(10%或者更多)患者，在接下來的21個月中，發生肝細胞癌的危險增加7倍之多。根據已有的肝細胞癌腫瘤學實踐指南，這些患者肝細胞癌發生率極端增高。
Wako診斷公司研制開發了這種檢測方法，該公司是美國Wako化學公司的分支機構。該公司的AFP-L3是一種AFP-L3%定量診斷試劑，以液相結合實驗為基礎。這種方法使用抗原與抗體之間的液相結合反應，通過柱層析法分離結合和游離形式的蛋白，而無須固相反應。LiBASys是Wako公司的自動分析儀，能夠同時向醫生提供總AFP 和AFP-L3%的含量。
 
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.