标题: 罗氏肺癌试剂盒获得中国批准 [打印本页] 作者: liuzff 时间: 2013-10-8 01:46 标题: 罗氏肺癌试剂盒获得中国批准 罗氏公司研发的用于肺癌诊断试剂盒Ventana Medical Systems获得中国管理部门批准上市。这种试剂盒可以搭配辉瑞生产的治疗肺癌药物Xalkori结合使用。对罗氏公司来说这是个巨大的胜利。中国作为一个巨大且增长迅速的市场，已经成为世界各国药企必争之地，尽管受累于最近的葛兰素史克行贿事件，但是中国医药市场的光明前景已经世所公认。此次，罗氏公司提供了在中国超过1000名患者的临床研究数据。Ventana试剂盒是通过检查ALK融合蛋白的表达水平来诊断非细小细胞肺癌的发生情况，具有很高的准确性。
详细英文报道：
Roche's ($RHHBY) Ventana Medical Systems arm gained pivotal Chinese regulatory approval for a companion diagnostic that pairs with Pfizer's ($PFE) targeted lung cancer drug Xalkori.
That's a big win, to say the least. China's healthcare market is huge and continues to grow rapidly, despite a recent regulatory crackdown. And emerging economies offer major opportunities for diagnostic, device and drug companies alike. For Roche's diagnostic arm, it adds to the company's continued, rapid development and rollout of companion diagnostic tests.
Based on data involving 1,000 patients in China, the country's Food and Drug Administration approved the Ventana ALK immunohistochemistry assay. It's designed to screen for the anaplastic lymphoma kinase (ALK) fusion protein, whose targeting has helped shrink cancer tumors in patients positive for the gene. Pfizer's Xalkori is also OK'd in China to treat patients with locally advanced or metastatic ALK-positive non-small cell lung cancer, and the test can now be used in tandem to spot non-small cell lung cancer patients who are positive for ALK. During the trial, the test worked on par with an Abbott ($ABT) diagnostic that also goes with Xalkori.
The approval "allows us to offer our customers ALK diagnostic testing in non-small cell lung cancer--one of the most prevalent and deadly cancers in China--as part of our active pursuit of personalized healthcare initiatives through new innovative products," Fatt-Heng Wong, general manager of Roche Diagnostics China, said in a statement.
Roche's Ventana ALK IHC assay now has approval in 53 countries, the company notes. And while its applied science and diabetes products are slumping--the company may be looking to sell its glucose meter business--molecular diagnostics sales are rising steadily.