肝癌诊断试剂GPC3将投入临床

2015-10-18 MedSci MedSci原创

第二军医大学东方肝胆外科医院王红阳院士领衔的课题组经十余年攻关，成功研发出新型肝癌诊断试剂Glypican-3（以下简称GPC3）。日前，该课题组与福州迈新生物技术开发有限公司联合申报的GPC3检测试剂盒获得国家食品药品监督管理总局颁发的三类医疗器械注册证，将正式在临床推广应用。据悉，研究人员从肝癌cDNA文库分离得到GPC3基因，发现其在肝癌中的阳性表达率高达80%以上，有望与AFP协同用于肝癌

第二军医大学东方肝胆外科医院王红阳院士领衔的课题组经十余年攻关，成功研发出新型肝癌诊断试剂Glypican-3（以下简称GPC3）。日前，该课题组与福州迈新生物技术开发有限公司联合申报的GPC3检测试剂盒获得国家食品药品监督管理总局颁发的三类医疗器械注册证，将正式在临床推广应用。

据悉，研究人员从肝癌cDNA文库分离得到GPC3基因，发现其在肝癌中的阳性表达率高达80%以上，有望与AFP协同用于肝癌的早期诊断。此外，GPC3在肝脏良性肿瘤或其他肿瘤转移到肝脏的病例中为阴性表达，但在肝癌的恶性发展中表达水平逐渐增高，尤其在AFP阴性的肝癌患者中有较高的检出率，对于提示复发、转移及评价手术治疗效果均有临床意义。

一项meta分析显示，单纯AFP和GPC3诊断肝癌的敏感性分别为51.9%（95%CI：0.47-0.56）和59.2%（95%CI：0.55-0.63），特异性分别为94% （95%CI：92.1-95.6%）和84.8%（95%CI：82-87.3%）。诊断性OR（DOR）分别为23.4 (95% CI 10.3-53.2) 和17.99 (95% CI 5.4-60.4)。如果复合两个markers，那么曲线下面积（AUC）为0.81 (95% CI 0.77-0.84).

课题组在大样本分析的基础上，建立了病理诊断试剂盒的标准化检测和评价方案，研发了GPC3检测试剂盒，并与迈新公司合作开展病理诊断试剂盒的多中心临床试验研究和产品注册申报。

该试剂盒为我国第一个具有完全自主产权的以单克隆抗体为基础研发的试剂盒，其临床有效性优于国外已上市的同类产品，特异性更强，细胞定位更准确。

王红阳介绍，该试剂盒主要用于肝癌的病理诊断与分型，尤其是肝脏肿瘤疑难病例，良、恶性的鉴别诊断，对临床开展肝脏肿瘤恶性病例个性化治疗和避免良性病例过度治疗具有重要应用价值。

相关出处：

Jia X, Gao Y, Zhai D, Liu J, Cai J, Wang Y, Jing L, Du Z.Assessment of the Clinical Utility of Glypican 3 as a Serum Marker for the Diagnosis of Hepatocellular Carcinoma.Technol Cancer Res Treat. 2015 Sep 14. pii: 1533034615605248

Tanaka Y, Aishima S, Kohashi K, Okumura Y, Wang H, Hida T, Kotoh K, Shirabe K, Maehara Y, Takayanagi R, Oda Y.Spalt-like transcription factor 4 immunopositivity is associated with epithelial cell adhesion molecule expression in combined hepatocellular carcinoma and cholangiocarcinoma.Histopathology. 2015 Aug 12. doi: 10.1111/his.12806.

Wang L, Yao M, Pan LH, Qian Q, Yao DF.Glypican-3 is a biomarker and a therapeutic target of hepatocellular carcinoma.Hepatobiliary Pancreat Dis Int. 2015 Aug;14(4):361-6.

Xu C, Yan Z, Zhou L, Wang Y.A comparison of glypican-3 with alpha-fetoprotein as a serum marker for hepatocellular carcinoma: a meta-analysis.J Cancer Res Clin Oncol. 2013 Aug;139(8):1417-24

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2016-08-27 李东泽

这篇资讯带给我们新知识，启发新思维，不论是科研还是临床工作都有很大的帮助。。。

84 0
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2016-07-19 doctorJiangchao

值得学习

119 0
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2015-11-02 licz0432

#GPC3#

59 0
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2015-12-27 忠诚向上

好学习很值得好学习

119 0
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2015-11-12 伊莎贝尔

看了

163 0
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2015-11-02 nizongzan

好好

120 0
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2015-10-19 sunlong28

为了积分我也是拼了~

122 0
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2015-10-19 sunlong28

赞一个~

108 0
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2015-10-19 sunlong28

谢谢分享~

105 0
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2015-10-18 huangwukui

太好了

116 0

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