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Management & Business Management & Business
May. 26, 2015

RIKEN GENESIS Co., Ltd., Becomes Japan's First Registered CLIA Lab

  Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) and Toppan Printing Co., Ltd. (HQ: Tokyo, Japan; President & Representative Director: Shingo Kaneko) are joint investors in RIKEN GENESIS Co., Ltd. (HQ: Tokyo, Japan; President & CEO: Yusuke Tsukahara), an affiliated company, which has been registered as Japan's first CLIA Lab.

 RIKEN GENESIS, which provides lab-assay services as well as products for genetic testing based on cutting-edge gene analysis technologies and bioinformatics, is one of the few Japanese companies that have technologies for, and experience/know-how in, the field of personalized medicine. Toppan Printing, the National Research and Development Agency, the Institute of Physical and Chemical Research (RIKEN) and RIKEN Venture Capital Co., Ltd., jointly established RIKEN GENESIS in 2007 to accelerate their practical application in real medical settings and widely promote RIKEN's leading-edge research achievements in the field of personalized medicine.
  In June 2014, Toppan Printing and Sysmex entered into an agreement to cooperate in the advancement of the genetic analysis testing industry, and each invested in RIKEN GENESIS.

  RIKEN GENESIS, an affiliated company of Toppan Printing and Sysmex, has been certified as Japan's first CLIA Lab by the Centers for Medicare and Medicaid Services (CMS), an organization belonging to the U.S. Department of Health and Human Services (HHS).
 

  A CLIA Lab is a laboratory certified according to the Clinical Laboratory Improvement Amendments (CLIA) formulated in the United States. Such labs are required to undergo periodic inspections to ensure quality maintenance, and being registered as a CLIA Lab certifies that RIKEN GENESIS meets world-class technology standards for quality assurance involving genetic analysis and has "sufficient reliability". Sufficient reliability is an evaluation indicating that genetic analysis testing performed by RIKEN GENESIS is of a technological level sufficient for the submission of genetic analysis data to the U.S. Food and Drug Administration (FDA).
 

Please refer to the RIKEN GENESIS website for further details.
https://rikengenesis.jp/contents/en_JPY/press20150528
 

  Sysmex, Toppan Printing, and RIKEN GENESIS will begin working on technological developments to further improve the quality and efficiency of gene analysis testing. At the same time, the companies will pursue R&D and business developments aimed at providing the high-value testing necessary to provide healthcare optimized for each individual patient.

Reference
Press release dated June 9, 2014 entitled "Sysmex and Toppan Printing to Collaborate in the Genetic Analysis Testing Industry"
http://www.sysmex.co.jp/en/corporate/news/2014/140609.html

*Information contained in the press release is current as of the date of the announcement,
but may be subject to change without prior notice.

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