The National Cancer Research Center announced the press release. For details, please see the following URL: https://www.ncc.go.jp/jp/information/pr_release/2018/0403/index.html
About Advanced Medical Approval for Multiplex Genetic Panel Inspection for Individualized Medicine
2018 April 3,
the National Research and Development Institute of the National Cancer Research Center
in English
Sysmex Corporation (Headquarters: Kobe City, President and Chairman, President and CEO: CEO: Hisashi Toyoshi) is a national cancer research center (Tokyo, President: “Multiplex gene panel examination for personalized medicine” conducted using “cancer-related gene panel (Note 1) examination system” that we have been working with in collaboration with “Sysmex” in April 2018 It is approved as advanced medical care 1 day (Note 2), and we will inform you that this examination will begin on April 9, 2018.
In cancer treatment, in addition to definitive diagnosis of cancer, many tests using genes and proteins such as drug effect prediction and recurrence monitoring are performed. Among them, by measuring a large number of genes of a cancer tissue at once, it is possible to analyze genetic changes inherent in the cancer of the patient, useful information useful for cancer diagnosis and treatment, selection of anticancer drugs “Cancer Clinical Sequence Inspection” has attracted attention.
To date, the National Cancer Research Center and Sysmex opened the Sysmex Cancer Innovation Laboratory in compliance with international quality standards in the central hospital in October 2015 with the aim of further promoting the development of new cancer diagnostic methods, We perform comprehensive gene analysis of patient’s sample (cancer tissue) using genetic diagnostic panel (NCC oncopanel) developed by National Cancer Research Center and next generation sequencer (3) measuring it, and treat We have been collaborating on “cancer-related gene panel examination system” to utilize for decision of policy and judgment of medication. We also conducted a clinical study TOP-GEAR (top-gear) project at the central hospital for early use in clinical practice, and conducted a pioneer screening of in-vitro diagnostic drugs / medical devices related to “cancer-related gene panel examination system” Designation is given as the designated item (designated number 4: target item (designated number: pioneer examination (28 examination) No. 1, designated date: H 29.2. 28) and “individual cancer gene panel examination system” is used for “individual We have been applying advanced medical applications for multiplex gene panel examination towards medical care.
“Multiplex gene panel examination for personalized medicine” performed using “cancer – related gene panel examination system” was approved as advanced medical on April 1, 2018. In response to this, from April 9, 2018 this examination will be started at the National Cancer Research Center Central Hospital. In addition, this study is planned to be carried out at advanced medical cooperation facilities for the purpose of expanding patient examination opportunities.
All specimens collected are subsidiaries of Sysmex Corporation and provide innovative genome center of RIKEN Genesis Inc. (Headquarters: Tokyo, President & CEO: Naoto Kondo “RIKEN Genesis” (Kawasaki Plant) to conduct measurements.
National Cancer Research Center, Sysmex, and RIKEN Genesis through approval for advanced medicine and approval for “cancer-related gene panel examination system” utilizing pioneering examination designation system as medicine / medical equipment for in vitro diagnosis, We will promote early utilization of “Multiplex Genetic Panel Inspection for Individualized Medicine” in the clinic and contribute to the development of personalized medicine.
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