Novomics

Sofrware Information

1. Use of nDx 1 Software is only available to partners who are registered separately in Novomics.

2. You must pass the certification procedure on the next screen before you can use the software.

3. Click the "Certification" button to install it automatically on your connection PC.

S/W InstallPlease enter your
partner number and certification number
Partner No. Certification No.

* Contact us : +82-2-2068-3700

History

History

  • 2020
  • 01 Initiate Perspective Clinical Trial for clinical evidence development – Innovative Medical Technology (13 Institutes)
    Investigator’s Meeting (Perspective Clinical Trial)
    02 Clinical trial (No.1033) approved by MFDS - nProfiler® 1 Indication expansion and Chemotherapy benefit classification in Low risk patients
    Establishment of Representative Office in Vietnam
    03 Pre-IPO Funding, 4 Institutional investment
    CE Marking Declaration of Conformity (DoC)
    04 China Inspection and Quarantine (CIQ202006264) Certification
    06 Innovative Medical Technology – Clinical trial for clinical evidence development, IRB Approved (10 Institutes)
  • 2019
  • 01 ISO 13485 Certification
    (Registr. No. 81 105 1534388, Scope: Design, development, manufacture and distribution of molecular diagnostic kits and software)
    02 Published on Yonsei Medical Journal “Single patient classifier assay, microsatellite instability, and Epstein-Barr virus status predict clinical outcomes in stage Ⅱ/Ⅲ gastric cancer”
    03 KOLAS Certification (ISO 17025, Approved no. KT834)
    KGMP Conformity Assessment – Completed (KCL-ABB-4405)
    04 Genetic Testing Institute Accreditation by Korea Centers for Disease Control and Prevention (Registr. No: 342)
    MOU with HANA-MED (Vietnam)
    05 Technology Transfer Agreement, Korea Research Institute of Standards and Science (Companion diagnostics technology)
    06 FDA Pre-submission (Q190608) and Meeting in USA (510K)
    07 Technology Transfer Agreement, Yonsei Univ. (Methods for classifying breast cancer subtypes)
    R&D Agreement with Yonsei Univ. College of Medicine on method for Spatial image analysis
    08 Import License-Vietnam (License No. 286/2019/CV-KMD, Class :Class C)
    09 Initiate Feasibility Test (8 institutes)
    11 Nominated as the first innovative medical technology by National Evidence-based Healthcare Collaborating Agency (NECA)
  • 2018
  • 03 Published on the Lancet Oncology (Online Published; March 19, 2018) “Predictive test for chemotherapy response in resectable gastric cancer: a multi-cohort, retrospective analysis”
    MOU with YIDA ICL of Nanyang the First People’s Hospital
    Establishment of a Corporation in Hongkong
    04 Project for industrial technology development by Ministry of Trade, Industry and Energy
    05 NET New technology Certification (Approved no. 1136) – method for classifying prognosis and chemotherapy benefit in gastric cancer stage II-III
    06 Published on Journal of Gastric Cancer “A modification of the TNM staging system for stage Ⅱ/Ⅲ gastric cancer based on a prognostic single patient classifier algorithm”
    07 Establishment of a Corporation in China
    MOU with Beijing University Cancer Hospital and Yonsei Cancer center for Collaborative research
    5 Institutional investment in Series C
    10 MOU with Yonsei Univ. College of Medicine for Collaborative research on methods for classifying breast cancer subtypes
    11 MOU with National Cancer Hospital (Vietnam) for Collaborative research
  • 2017
  • 01 ISO13485 Certification (Registration. No. 81 105 1534388, (Registr. No. 81 105 1534388, Scope: Design, development, manufacture and distribution of molecular diagnostic kits and software)
    02 Confirmatory Clinical Trial approved by MFDS
    03 6 Institutional investment in Series B
    KGMP Certification (KTC-AAB-160169)
    04 Technology Transfer Agreement, Yonsei Univ. (Patent Transfer)
    05 Confirmatory Clinical Trial Completed
    11 Permission of manufacturing business (No.5898) and product (Manufacturing certification No. 17-865) by MFDS [The 3rd newly developed medical device]
  • 2016
  • 01 ISO13485 Certification (Registration. No. 81 105 1534388, SCOPE: Design, Development, Manufacture and Distribution of IVD PCR Reagent Kits and SoftWare)
    03 KGMP Certification (KTC-AAB-160169)
    04 Technology innovation development industry by Korea Technology & Information Promotion Agency for SMEs
    07 Establishment of NGS system
  • 2015
  • 05 V.C. investment by 5 institutional investors
    06 Participation in the project for the development of source technology in health care of the Ministry of Future
    Establishment of GMP facility and diagnostics laboratory
    07 Renamed Novomics Co., Ltd.
    Moved Headquarter & Research Lab location (Yonsei Univ -> Dangsandong)
  • 2014
  • 04 Certification for Venture Company (No. 20160300151)
    07 Establishment of R&D Center (No: 2014113543 / Research Area: Product development-Others)
    10 Participating in R&D for cultivation of research-oriented hospital of the Ministry of Health and Welfare
  • 2013
  • 04 Execution of contract for the starting up of business by the faculty of and comprehensive technology transfer with Yonsei University Medical center
    06 Project for the development of core technology of biomedical equipment industry by the Ministry of Knowledge Economy (Bio)
    12 Project for the development of global market type business start-up technology of Ministry of SMEs and Startups (TIPS program)
  • 2010
  • 03 Approval for foundation of Novomics Meditech Co., Ltd. and faculty startup by Yonsei University