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.
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.
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.
Press release dated June 9, 2014 entitled "Sysmex and Toppan Printing to Collaborate in the Genetic Analysis Testing Industry"