羅氏公司研發(fā)的用于肺癌診斷試劑盒Ventana Medical Systems獲得中國(guó)管理部門(mén)批準(zhǔn)上市。這種試劑盒可以搭配輝瑞生產(chǎn)的治療肺癌藥物Xalkori結(jié)合使用。對(duì)羅氏公司來(lái)說(shuō)這是個(gè)巨大的勝利。中國(guó)作為一個(gè)巨大且增長(zhǎng)迅速的市場(chǎng)，已經(jīng)成為世界各國(guó)藥企必爭(zhēng)之地，盡管受累于最近的葛蘭素史克行賄事件，但是中國(guó)醫(yī)藥市場(chǎng)的光明前景已經(jīng)世所公認(rèn)。此次，羅氏公司提供了在中國(guó)超過(guò)1000名患者的臨床研究數(shù)據(jù)。Ventana試劑盒是通過(guò)檢查ALK融合蛋白的表達(dá)水平來(lái)診斷非細(xì)小細(xì)胞肺癌的發(fā)生情況，具有很高的準(zhǔn)確性。（生物谷Bioon.com）
詳細(xì)英文報(bào)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.
