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白血病融合基因筛查试剂盒获得了CE IVD标志

By LabMedica International staff writers
Posted on 10 Aug 2015
最近发布的白血病融合基因筛查试剂盒符合欧盟关于体外诊断医疗设备的规定,是具有CE-IVD标志的产品。

这款筛查试剂盒是一件灵敏、特异、可靠且经济实惠的工具,它容易执行,可对白血病融合转录进行常规筛查。在临床场合,检测癌症特有的基因非常重要,这样能确保做出正确诊断并选择最佳治疗。

美国加利福尼亚州旧金山市QuanDx股份有限公司的白血病融合基因(Q30)筛查试剂盒是一种定性的体外诊断设备,临床实验室用它和新颖的多重逆转录实时聚合酶类反应(PCR)系统,可同时检测30个融合基因。每次反应中融合基因和控制基因转录物共同被扩增并被特异的荧光探针识别。白血病融合基因(Q30)将变革现有的检验,为优化病人的化验提供了一台更高效、更经济的系统,因为检测融合基因的现有方法都有鲜明的弱点。两到三小时可以得到检验结果。

QuanDx公司首席执行官Matthew Lei博士说:“这标志着我公司迈出的重要一步,完善了我们在三月份取得的ISO 13485: 2003认证。为了把只做科研用途的产品转化为体外诊断产品,我们已实现了内部质量控制过程和监管过程。获得CE标志证明我们向欧洲市场提供优质诊断产品的决心。这是我们的第一款体外诊断产品。该产品线的发布将把我们测定产品的应用范围扩大到鉴定血癌的融合基因。”

QuanDx公司销售与市场副总裁Graeme Duncan评论说:“获得CE标志的白血病融合基因产品将于六月在欧洲上市。CE标志确保实验室和临床医师能够依靠白血病融合基因筛查试剂盒评估并分类血癌,最后得到准确结果。欧洲市场是美国以外的一个重要增长点 ,白血病融合基因(Q30)筛查试剂盒的CE-IVD状态让我们能不断加速我们进军欧洲临床市场的计划。”

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