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云克隆营收6000万数据糊不圆 科技厅抽检唯一不合格

2017-09-20 07:07:02   中国经济网

但记者调查却发现,云克隆公司的核心产品ELISA(中文全称为酶联免疫吸附法)曾经遭到过海外学者的质疑,其子品牌优尔生(USCN)的一款试剂盒被指无效。

2014年,当时为多伦多大学研究人员的IoannisPrassas博士在生命科学国际核心刊物ClinicalChemistry上撰文指出,为了验证他们一项重大发现——人体新型的胰腺癌生物标志物CUZD1,他和他的研究团队整整忙碌了两年时间、花费的研究经费超过五十万美元,但一直失败。

IoannisPrassas博士在文章中表示,他使用USCN和R&D公司两个供应商的试剂盒做对比实验,发现USCN生产的CUZD1试剂盒中的抗体被验证无效。他在论文中提到,对比实验结果显示,CUZD1并未与目标抗原结合,而是与另一种完全不同的抗原CA125结合,IoannisPrassas博士这才意识到失败的因素是一支包含在CUZD1ELISA试剂盒中的抗体。

文章称,这种特异性直接导致了ELISA实验结果的巨大偏差,从而造成了该研究项目的接连失败。因此,IoannisPrassas博士在文章中将矛头直接指向试剂盒产品的供应商USCNLifeSciences(即云克隆公司前身武汉优而生)。

  屏障系统成唯一一家不合格单位

据每日经济新闻2016年报道,从事生命科学领域检测试剂研发、制备,为科研人员提供检测工具的公司,理应对生产环境以及操作流程都有非常严格的要求。但有这样一家即将在创业板上市、并自称处于“细分行业领先地位”的生命科技公司——武汉云克隆科技股份有限公司,却在当地科技厅的实验动物抽查行动中出了问题。

根据湖北省科技厅发布的关于2016年实验动物抽查结果,云克隆公司因屏障系统运行及不按程序操作等问题不予通过。那么,云克隆公司此次问题因何引起?又会对公司产品造成哪些影响?会不会给公司上市前景蒙尘?

作为一家从事科研专用的检测试剂研发、制备及销售的公司,云克隆公司在2016年披露的招股书中称,公司经过不断研发所形成的自主技术产品在国际上已经占据一定的市场份额,用户包括葛兰素史克、罗氏、赛默飞、辉瑞以及哈佛大学、耶鲁大学、斯坦福大学、牛津大学等研究机构。

然而,这家宣称在国内处于“细分行业领先地位”的生命科学技术公司,却在IPO前夕收到了来自湖北省科技厅的通报。据该通报披露,云克隆公司成为了湖北省科技厅此次实验动物抽查行动中,唯一一家不合格单位,问题就出在了其屏障系统及操作不规范上。

《每日经济新闻》记者从湖北省科技厅确认了云克隆公司抽检不合格的事实,一位参与现场抽检的人士甚至表示,“不用检测就知道不合格。”

据了解,屏障系统出现问题将对实验动物场所环境产生影响,进而影响实验动物生长。广州一位不愿具名的生物医药行业专业人表示,如果生产环境不达标,有可能导致产品污染、灵敏度下降、失效等情况,从而影响检测结果。

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