On December 25, 2018 Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) reported that it received manufacturing and marketing approval in Japan for the first time for the OncoGuide NCC Oncopanel System (the "System"), which the Company developed jointly with the National Cancer Center (Location: Tokyo, Japan; President: Hitoshi Nakagama), to be used in cancer genome profiling (Press release, Sysmex, DEC 25, 2018, View Source [SID1234532273]). The System constitutes a combination medical device,1 comprising the OncoGuide NCC Oncopanel Analysis Program and the OncoGuide NCC Oncopanel Kit, and is used in combination with a next-generation sequencer.2

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In recent years, attention has focused on clinical cancer gene testing that obtains a tumor genome profile3 which analyzes abnormalities in cancer-specific genes in cancer patients and elicits useful information to aid in cancer diagnosis and treatment and the selection of anti-cancer drugs.

With the aim of introducing clinical cancer gene testing into clinical settings at an early stage, in October 2015 Sysmex opened the Sysmex Cancer Innovation Laboratory (SCI-Lab), which conforms to international standards, within the National Cancer Center Hospital. At this facility, we used the System when participating in the TOP-GEAR Project, performing clinical research to determine treatment methods for cancers with actionable genomic aberrations. Based on the results of this research, Sysmex applied for the Ministry of Health, Labour and Welfare’s Sakigake Designation4 of the System and a next-generation sequencer used in combination with the System, as in vitro diagnostic pharmaceutical and medical devices. We obtained this designation on February 28, 2017. (Designation number: Sakigake screening (28) No. 1)

Thereafter, Sysmex completed development of the System as a combination medical device and applied for manufacturing and marketing approval in June 2018. We have now received this approval. The System targets all solid tumors and is intended for use in obtaining profiles pertaining to 114 cancer-related genes from patients’ tumor tissue (including cytology samples).

Meanwhile, on April 1, 2018, "Multiplex Gene Panel Testing to Advance Personalized Medicine" received approval as the Advanced Medical Care.5 This System and next-generation sequencers have been used in 350 cases at 50 core hospitals for cancer genomic medicine, including the National Cancer Center Hospital, and affiliated hospitals.

To expand opportunities for patients to receive this testing, we plan to apply for health insurance coverage for the System. Our aims are to deliver a new method for diagnosing cancer as quickly as possible and to promote the advancement of healthcare.

New Product Overview

General name: Gene mutation analysis set (for cancer genome profiling)
Product name: OncoGuide NCC Oncopanel System (Approval no.: 23000BZX00398000)
Launch: February 2019 (expected)
Target market: Japan
Target facilities: Medical institutions that have in place diagnostic systems appropriate for cancer genome profiling6

Features

・ A system developed by NCC and Sysmex
・Targets for analysis all solid tumors, regardless of cancer type
・Obtains from tumor tissue profiles pertaining to 114 cancer-related genes, checks them against a database of gene abnormalities, and provides annotation information

Terminology

1 Combination medical device:
A combination of two or more types of items (pharmaceuticals, medical devices or regenerative medicines) constituting a medical device to be manufactured and marketed.

2 Next-generation sequencer:
An analyzer for reading large volumes of DNA base sequences.

3 Tumor genome profile:
Information obtained by simultaneously analyzing mutations, copy number alterations and fusion of multiple genes of significance to cancer diagnostics.

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 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 put 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 with the aim of conquering international competition, to receive approval in Japan prior to other countries.

5 Advanced Medical Care:
Based on a "fundamental accord" in December 2004 between the Minister of Health, Labour and Welfare; the Cabinet Office Minister of State in charge of special missions (regulatory reform, industrial revitalization); the minister in charge of administrative reform; and the minister in charge of special zones for structural reform and regional revitalization, this system was approved in combination with healthcare provided with insurance coverage from the perspective of ensuring the safety of Japanese citizens, containing patient burdens, expanding citizens’ choices, and increasing convenience.

6 Medical institutions that have in place diagnostic systems appropriate for cancer genome profiling:
On December 25, 2017, the Ministry of Health, Labour and Welfare submitted a notification outlining requirements, titled "The Establishment of Core Hospitals for Cancer Genomic Medicine."
Overview of requirements
Institutions must have in place the following systems:
・ System for ensuring the quality of gene panel testing (may be outsourced)
・ Review committee to interpret test results
・ System to perform genetic counseling
・ System for introducing and conducting clinical trials and clinical studies
・ System for gathering, managing and registering appropriate clinical information