Companion Diagnostic

A New Approach to Companion Diagnostic Partnership

The NGS based Diagnostic Kit

For detection of NTRK Gene Fusion

01.
Neurotropic Tyrosine Receptor Kinase (NTRK) is a type of biomarker for cancer therapy and can be found in over 25 different types of cancer. NTRK gene fusions can be detected with a number of biomarker tests including NGS (Next Generation Sequencing). This is the only way to identify people who may be eligible for therapies that target these mutations. OrigiMed has one of the clinical databases with information on gene fusion. OriFusion is a patented technique, in partnership with Bayer, to detect specific gene fusions which allows treatment with targeted therapies such as Entrectinib. Companion Diagnostics (CDx) is a testing panel that screens for hundreds of gene sequences to be compared against known matches, which then allows for other specific targeted therapies to be used.

Companion Diagnostic Development

02.

Biomarker-Driven Trials

03.
Accelerating biomarker-driven clinical trials through better design, planning and enrollment
  • Chinese patients identified for potential enrollmentin clinical trials

  • Biomarker-driven trials

02.
NTKR Clinic
  • The Pan-Cancer Specialty Clinic for NTRK gene fusion in China
  • The EU CE Certificated DNA+RNA NGS NTRK Kit
  • Clinical and Molecular Data
  • One Stop Solution for Pharmaceutical Partners
03.
中国第一个进入创新通道的

前瞻性原研伴随诊断试剂同步开发

  • 纯内资企业,助力HGRAC高效申报
    纯内资企业,HGRAC限制少
  • 完备的注册经验助力申报高效
    多家药企共同开发CDx的经验积累
    纯内资企业,HGRAC限制少
    临床试验机构资源丰富加速立项伦理进程
    500+核心医院;40个城市
    熟悉临床试验审批流程
    注册资料准备、数据统计分析经验
    CMDE审评人员及时有效沟通途径
    前期临床试验方案沟通
    创新咨询和窗口咨询
    作为业内专家参与CMDE讨论
    业内专家闭门会
  • 药企合作事业部

    100% 项目管理人员通过GCP培训

  • IVD产品开发

    丰富的LDT / IVD产品开发经验

  • 遗传办事务

    专设的遗传办法规主管,实时关注
    遗传办法规及临床试验项目监控

  • CDx项目经理

    伴随诊断项目管理专人对接 双PM对接

  • 伴随诊断注册

    丰富的IVD试剂盒和软件注册经验

  • 质量管理部

    完善及标准化的质量管理体系

  • Contact address

    5th Floor, Building 3, 115 Xinjun Ring Road, Minhang District, Shanghai

    Floor 4, Information Building 2, Zhaolou Road 3576 , Pujiang Town, Minhang District, Shanghai

  • Customer Service Telephone

    400-821-9890
    Service Hours:9:00-18:00 Monday to Friday (except statutory holidays)

  • Customer Service Email

    zbservice@origimed.com
    We will reply you as soon as we receive the email.

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