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Genomic medicine involves using next-generation sequencers¹ and other instruments to study individuals’ genomic information (gene sequence information), and to diagnose, treat and prevent cancer and other diseases more efficiently and effectively based on the results obtained. Clinical sequence testing—testing that performs highly precise analysis of gene sequence information based on a high level of quality assurance for diagnosis and treatment—is important to the promotion of genomic medicine.

To date, Sysmex has established a clinical sequencing laboratory named the Sysmex Cancer Innovation Laboratory (SCI-Lab) within the National Cancer Center (NCC) Hospital. This lab uses a cancer-related gene panel testing system composed of next-generation sequencers, gene diagnostic panels² developed by NCC, and an analysis program jointly developed by NCC and MKI for comprehensive gene analysis on patient specimens (cancer tissue) to conduct research aimed at assisting in determining treatment and drug administration.

In addition, the lab has collaborated with Sysmex subsidiary RIKEN GENESIS, which has the first CLIA³ lab registered in Japan, with strong quality control in the operation of SCI-Lab, providing highly reliable testing based on international quality assurance standards.

Sysmex, RIKEN GENESIS and MKI have signed a comprehensive collaboration agreement aimed at promoting cooperation in the field of genomic medicine.

Under this comprehensive agreement, the three companies are engaging in the development of 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 System⁴ for in vitro diagnostic reagents. RIKEN GENESIS and MKI have also entered a business alliance to begin a new assay service for clinical cancer sequence testing. This service will conduct processes from specimen measurement to analysis in Japan, facilitating the swift reporting of test results to patients.

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

Terminology
	1	Next-generation sequencer: An analyzer capable of simultaneously reading large quantities of DNA bases and sequences that contain genetic information.
	2	Gene diagnostic panel: A type of assay that enables simultaneous analysis of the mutation, amplification and combination of multiple diagnostically important genes. Gene diagnostic panels developed mainly by the National Cancer Center are created to appropriately diagnose gene mutations characteristic of Japanese people.
	3	U.S. Clinical Laboratory Improvement Amendment (CLIA): A CLIA lab is certified as conducting testing with quality assurance in accordance with the US Clinical Laboratory Improvement Act standards. CLIA labs are required to undergo periodic inspections to ensure quality maintenance. Being registered as a CLIA lab certifies quality control for testing.
	4	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 in 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.