赛默飞获CE-IVD认证 将开发出Oncomine实体瘤融合转录试剂盒

  近日，赛默飞世尔科技 (Thermo Fisher Scientific)获得CE-IVD认证标志，这标志着其将开发出基于新一代测序技术的Oncomine实体瘤融合转录试剂盒，这种试剂盒是利用Ion Ampliseq测序技术来检测包括ALK，ROS-1， RET，和NTRK1基因在内的一系列基因重排情况，而目前OncoNetwork联盟的研究者正在同Thermo的科学家们联合来开发这款试剂盒并且在肺癌中证实其效果。

  这种试剂盒适用于甲醛固定石蜡包埋的组织，而且仅需要10ng的RNA就可以进行检测，研究者Jose Costa表示，综合以上内容我们就可以将这种试剂盒选择性地同病人的预后以及疗法决策指导进行联合，来展现出对结肠癌及肺癌患者新一代的遗传性检测手段。

  研究者开发的融合性“面板”是第二个获得CE-IVD认证标志的Oncomine“面板”，在1月时Thermo获得了Oncomine实体瘤DNA面板的CE-IVD认证，其主要致力于进行肺癌和结肠癌的检测；研究者Mike Nolan说道，当利用Oncomine试剂盒进行应用时，我们就可以利用简化的步骤，在融合转录的帮助下同时鉴别出多种突变。

  目前Thermo仅会利用这种全面的Oncomine来作为研究使用，而且其正在同GSK和辉瑞联合开发一种基于市场化的“伴随诊断”（Companion Diagnostic）策略，目前他们已经将其递交至FDA，并希望FDA可以批准，另外Thermo目前也在同美国国立癌症研究所进行联合研究来证实Oncomine“面板”在NCI-MATCH试验中的作用效率。OncoNetwork联盟在Thermo的协调努力下旨在开发AmpliSeq的癌症测序面板，其成员包括来自意大利维罗纳大学等处的研究人员。（转化医学网360zhyx.com）

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Thermo Fisher Scientific has received CE-IVD marking for its next-generation sequencing-based Oncomine Solid Tumor Fusion Transcript kit.

The kit makes use of the Ion AmpliSeq technology and detects rearrangements involving ALK, ROS-1, RET, and NTRK1 genes. Researchers within Thermo's OncoNetwork Consortium worked with Thermo Fisher to develop the kit and validate it for lung cancer.

The kit is amenable for use with formalin-fixed paraffin-embedded tissue and requires as little as 10 ng of RNA.

"The comprehensive content, selected to align with patient prognosis and therapy decision guidance, represents the new generation of genetic tests for colon and lung cancer patients," Jose Costa, from the IPATIMUP Medical Faculty of Porto, Portugal, said in a statement.

The fusion panel is the second Oncomine panel to receive CE-IVD marking. In January, Thermo Fisher received CE-IVD marking for its Oncomine Solid Tumor DNA panel, which focuses on lung and colon cancers. In today's statement, Mike Nolan, vice president and general manager of Oncology at Thermo Fisher, said that when the Oncomine kits are used together, "mutations can be identified simultaneously with fusion transcripts, all in a single streamlined procedure."

The company also has a more comprehensive Oncomine panel for research use only, and is developing a companion diagnostic based on markers within that panel in collaboration with GlaxoSmithKline and Pfizer and plans to submit it to the US Food and Drug Administration for premarket approval. In addition, it is working with the National Cancer Institute to validate an Oncomine panel for the NCI-MATCH trial.