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Cancer-Related Gene Panel Testing System Designated Under the Ministry of Health, Labour and Welfare’s Sakigake Designation System

Date: 2017-03-01 Tags: Press release

Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) and the National Cancer Center (Location: Tokyo, Japan: President: Hitoshi Nakagama) are jointly developing a cancer-related gene panel testing system. On February 28, 2017, this system received the first designation under the Ministry of Health, Labour and Welfare’s Sakigake Designation System1 for in vitro diagnostic pharmaceuticals.

Genomic medicine involves studying individuals’ genetic information included in DNA and diagnosing, treating and preventing disease more efficiently and effectively based on the results obtained. In the realization of genomic medicine, high-quality testing system configuration and quality control of testing have arisen as issues.

Genomic medicine for cancer requires a cancer-related gene panel2, next-generation sequencer3 and an analysis program. The cancer-related gene panel testing system (the “System”) that has been designated under the Sakigake Designation System comprises these three elements. The System enables the simultaneous analysis of more than 100 types of genetic mutation. This System allows for multiple gene mutations to be detected from specimens (cancer tissue) of patients for whom standard treatment (including treatment with anti-cancer drugs) has been concluded or is expected to conclude, supporting decisions on treatment methods once standard treatments have ended.

Sysmex and the National Cancer Center have opened a laboratory that meets international standards with the National Cancer Center Hospital, and have been pursuing clinical research toward the introduction of genomic medicine into routine clinical practice. Sysmex and the National Cancer Center plan to use the System in the cancer diagnostic panel (NCC Oncopanel) that the National Cancer Center has developed for this research.

Sysmex will work toward the earliest possible development of new cancer diagnostic methods, with the aim of realizing medicine optimized to individual patients, thereby contributing to the advancement of healthcare.
 

Terminology   

  1. Sakigake Designation System:
    This system was designed to fast-track the provision of leading-edge global therapeutic drugs to Japanese patients. Novel drugs that satisfy the four conditions outlined below may be designated under the Sakigake Designation System at a comparatively early stage of development and are given priority for clinical trial consultation and review. The system also aims to encourage applicants to create production systems in accordance with the approval review schedule and putting these into practical use more quickly by facilitating post-approval provision in medical settings. Four designation conditions apply: (1) an innovative mechanism of action, (2) targeting serious and life-threatening diseases, (3) demonstration of prominent effectiveness and (4) the treatment being developed and receiving targeting approval in Japan prior to other countries.
  2. Cancer-related gene panel:
    An assay kit that is designated to analyze the mutation, proliferation and fusion of multiple genes having diagnostic significance. NCC Oncopanel, a gene diagnosis panel developed mainly by the National Cancer Center, was created to appropriately diagnose gene mutations characteristic of Japanese patients.
  3. Next-generation sequencer:
    An analyzer capable of simultaneously reading large quantities of DNA bases and sequences that contain genetic information.

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