FDA批准Agilent旗下公司Dako的新型伴随诊断技术用于默克公司的非小细胞肺癌肺癌检测

  今日，Agilent Technologies旗下公司Dako表示，FDA已经批准了该公司的一种新型伴随诊断技术，与此同时还批准了默克公司的一种非小细胞肺癌药物。
  名为PD-L1 IHC 22C3 pharmDx的伴随诊断技术通常被用于确定恶性非小细胞肺癌患者是否对默克公司的抗PD-1疗法Keytruda(pembrolizumab)有反应，该疗法目前已经得到FDA批准用于治疗肿瘤细胞表达PD-L1的转移性非小细胞肺癌患者，以及疾病恶化或进行铂化疗后的患者。
  Dako公司同默克公司进行合作开发了这种新型的诊断技术，其将被用于确定患者机体的肿瘤是否会表达PD-L1蛋白，Dako公司表示，它们希望这项技术明年在加拿大、欧洲及其它地区获得相关监管部门的批准。
  默克实验室（Merck Research Laboratories）的高级副总裁Roger Dansey在一份声明中指出，这种首个PD-L1新型诊断技术的批准可以极大程度地帮助指导患者进行疗法的选择和决策；目前Dako和默克公司在2014年5月已经达成协议开发Keytruda疗法的伴随诊断技术。
  从独立角度来看，实验室合作和寻求诊断者都表示，他们将提供利用PD-L1 IHC 22C3 pharmDx来进行的临床实验室检测手段，而临床医师们则可以帮助指导这种测试。（转化医学网360zhyx.com）
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FDA Approves Dako CDx for Merck's NSCLC Test
Agilent Technologies' Dako today said that the US Food and Drug Administration has approved the firm's companion diagnostic assay in connection with a simultaneous approval for Merck's non-small lung cancer drug.

The companion diagnostic called PD-L1 IHC 22C3 pharmDx is used to determine whether a patient with advanced NSCLC is likely to respond to Merck's anti-PD-1 therapy Keytruda (pembrolizumab), which was approved by the FDA for treating patients with metastatic NSCLC whose tumors expressed PD-L1 and whose disease has progressed on or after platinum-containing chemotherapy.

Dako's test, developed in partnership with Merck, will be used to determine whether the patient's tumor expresses the PD-L1 protein. Dako said that it hopes to gain regulatory clearance for the assay in Canada, Europe, and other jurisdictions next year.

"The approval of the first PD-L1 diagnostic has the potential to provide information that will help guide treatment decisions for many patients," Roger Dansey, senior vice president at Merck Research Laboratories, said in a statement.

Dako and Merck announced a deal to develop a CDx for Keytruda in May 2014.

Separately, Labortory Corporation and Quest Diagnostics each said that they will provide clinical laboratory testing using PD-L1 IHC 22C3 pharmDx. Physicians are able to order the test from either firms starting today. Also, GE Healthcare's Clarient is offering the test.