Wako公司开发肝癌生物学指标

 
一种新型检测系统被设计用于确定慢性肝脏疾病患者患肝癌的风险。这套系统已经获得美国食品药品管理局的许可。
在世界范围内，肝细胞癌是第四种最常见的癌症，第三种最常见的癌症相关死亡原因。危险因素包括由乙型肝炎病毒和丙型肝炎病毒导致的慢性肝炎和肝硬化。筛查和普查的临床效率依赖于早期诊断，如果想要得到有效治疗的话。
这种新型检测方法使用人甲胎球蛋白(AFP)，这是一种糖蛋白。AFP-L3是唯一由得病患者肝脏中癌细胞生成蛋白。在加拿大和美国的一项多中心、前瞻性、双盲、长期临床试验中，对该检测方法进行了研究。结果显示AFP-L3%升高(10%或者更多)患者，在接下来的21个月中，发生肝细胞癌的危险增加7倍之多。根据已有的肝细胞癌肿瘤学实践指南，这些患者肝细胞癌发生率极端增高。
Wako诊断公司研制开发了这种检测方法，该公司是美国Wako化学公司的分支机构。该公司的AFP-L3是一种AFP-L3%定量诊断试剂，以液相结合实验为基础。这种方法使用抗原与抗体之间的液相结合反应，通过柱层析法分离结合和游离形式的蛋白，而无须固相反应。LiBASys是Wako公司的自动分析仪，能够同时向医生提供总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.