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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.
中國第一個(gè)進(jìn)入創(chuàng)新通道的

前瞻性原研伴隨診斷試劑同步開發(fā)

  • 純內(nèi)資企業(yè),助力HGRAC高效申報(bào)
    純內(nèi)資企業(yè),HGRAC限制少
  • 完備的注冊經(jīng)驗(yàn)助力申報(bào)高效
    多家藥企共同開發(fā)CDx的經(jīng)驗(yàn)積累
    純內(nèi)資企業(yè),HGRAC限制少
    臨床試驗(yàn)機(jī)構(gòu)資源豐富加速立項(xiàng)倫理進(jìn)程
    500+核心醫(yī)院;40個(gè)城市
    熟悉臨床試驗(yàn)審批流程
    注冊資料準(zhǔn)備、數(shù)據(jù)統(tǒng)計(jì)分析經(jīng)驗(yàn)
    CMDE審評(píng)人員及時(shí)有效溝通途徑
    前期臨床試驗(yàn)方案溝通
    創(chuàng)新咨詢和窗口咨詢
    作為業(yè)內(nèi)專家參與CMDE討論
    業(yè)內(nèi)專家閉門會(huì)
  • 藥企合作事業(yè)部

    100% 項(xiàng)目管理人員通過GCP培訓(xùn)

  • IVD產(chǎn)品開發(fā)

    豐富的LDT / IVD產(chǎn)品開發(fā)經(jīng)驗(yàn)

  • 遺傳辦事務(wù)

    專設(shè)的遺傳辦法規(guī)主管,實(shí)時(shí)關(guān)注
    遺傳辦法規(guī)及臨床試驗(yàn)項(xiàng)目監(jiān)控

  • CDx項(xiàng)目經(jīng)理

    伴隨診斷項(xiàng)目管理專人對(duì)接 雙PM對(duì)接

  • 伴隨診斷注冊

    豐富的IVD試劑盒和軟件注冊經(jīng)驗(yàn)

  • 質(zhì)量管理部

    完善及標(biāo)準(zhǔn)化的質(zhì)量管理體系

  • 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.

All rights reserved in ? Copyright 2022 OrigiMed Ltd

Registration Number:滬ICP備16027109號(hào)-1

滬公網(wǎng)安備 31011202014892號(hào)

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