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安进与Illumina合作开发肿瘤学伴侣诊断试剂盒

  1. Illumina
  2. 伴侣诊断试剂盒
  3. 基因突变
  4. 安进
  5. 肿瘤学

来源:生物谷 2014-01-20 09:07

安进和Illumina达成协议,开发伴侣诊断试剂盒。此次合作表明Illumina致力于与制药公司合作,将其领先的多基因、新一代测序(Multigene-NGS)技术引入肿瘤护理领域。

2014年1月18日讯 /生物谷BIOON/ --安进(Amgen)和Illumina公司1月16日联合宣布,双方已达成协议,开发和商业化基于多基因、新一代测序(NGS)的Vectibix(panitumumab,帕尼单抗)伴侣诊断试剂盒。Vectibix是一种全人源化抗EGFR单克隆抗体药物,已获FDA和欧盟批准,用于转移性结直肠癌的治疗。

该伴侣诊断试剂盒将开发用于Illumina的MiSeqDx系统,该系统已于2013年11月获FDA的上市前许可(premarket clearance),同时于2013年7月获欧盟CE标志,这是首个获得FDA许可的高通量DNA测序仪。

此次合作,将验证一种检测平台,该平台可检测肿瘤中RAS的突变状态,从而鉴别出适于Vectibix治疗的患者群体。在获得CE标志及FDA批准后,Illumina计划重点在美国和欧盟商业化该试剂盒。此次合作,同时也表明了Illumina致力于与治疗公司合作,并将其领先的多基因、新一代测序(Multigene-NGS)技术引入肿瘤护理领域。

与传统的检测技术相比,新一代测序(NGS)具有显著的优势。传统检测技术,通常只检测一种或几种变体,而多基因新一代测序技术,针对每一位患者的肿瘤,可提供更完整的基因图(genetic picture),从而提供更全面的关键治疗决策信息。多基因新一代检测技术,将更好地改善癌症的护理和预后。(生物谷Bioon.com)

英文原文:Amgen and Illumina Enter Agreement to Develop Oncology Companion Diagnostic Test

Illumina to Develop In Vitro Diagnostic (IVD) Kit on its FDA-Cleared MiSeqDx™ Next-Generation Sequencing (NGS) Instrument for Amgen’s Vectibix (Panitumumab)

SAN DIEGO--(BUSINESS WIRE)--
Illumina, Inc. (ILMN) today announced it has entered into an agreement with Amgen Inc. to develop and commercialize a multigene, NGS-based test as a companion diagnostic for Vectibix (panitumumab), a fully human anti-EGFR monoclonal antibody therapeutic for the treatment of metastatic colorectal cancer approved in the US and EU. Under the terms of the collaboration, premarket approval of the test by the US Food and Drug Administration (FDA) and other regulatory bodies will be sought. The test will be developed for use with Illumina's MiSeqDx™ instrument, which received premarket clearance from the FDA on November 19, 2013 and was CE-marked for the European Union on July 16, 2013.

The collaboration will seek to validate a test platform that can identify RAS mutation status of patients who would be appropriate to receive Vectibix. Following CE marking and FDA approval, Illumina plans to commercialize the test with a focus on US and EU markets. This collaboration also demonstrates Illumina’s commitment to partnering with therapeutics companies and to bringing its leading NGS technologies into oncology care.

“This collaboration is consistent with our strategy to bring the power of NGS to clinical diagnostics,” said Nick Naclerio, Senior Vice President of Corporate and Venture Development and General Manager of Illumina’s Enterprise Informatics business at Illumina. “With three FDA-cleared NGS products in our portfolio, we intend to complement internal development programs by taking products developed with external partners through the FDA submission process. Amgen is a key partner given their leadership in therapeutic development and strong track record in commercializing novel products.”

Dr. Rick Klausner, Chief Medical Officer and acting General Manager of Illumina’s Oncology business, added, “NGS provides an advantage over traditional technologies that typically detect only one or a few variants. Multigene NGS panels provide a more complete genetic picture of each patient’s tumor, which can better inform critical treatment decisions. We see the development of multigene diagnostic tests as a natural evolution to improve cancer care and outcomes.”

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