Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) received approval on June 1, 2019 for insurance coverage for the first time in Japan for the OncoGuide NCC Oncopanel System, a gene mutation analysis set for use in cancer gene profiling (the “System”). The Company received manufacturing and marketing approval for the System on December 25, 2018.
The System’s targets for analysis are solid tumors. By obtaining a comprehensive cancer genomic profile of tumor tissue, the System analyzes abnormalities in cancer-specific genes in patients to provide information that is useful in determining treatment methods, including accurate diagnoses and the selection of anti-cancer drugs. Going forward, tests using the System will be covered under health insurance. This is expected to increase the opportunities for more patients to receive testing.
The System, which Sysmex developed in collaboration with the National Cancer Center (Location: Tokyo, Japan; President: Hitoshi Nakagama) with the aim of early clinical implementation of clinical cancer gene testing,1 received manufacturing and marketing approval as Japan’s first system for cancer genome profiling on December 25, 2018.2
The Innovation Genome Center (Kawasaki Office) of Sysmex subsidiary RIKEN GENESIS Co., Ltd. (HQ: Tokyo, Japan; President and CEO: Naoto Kondo) has received CAP,3 CLIA4 and ISO 151895 certifications. These certifications indicate that the center is technologically equipped to provide quality data in accordance with international standards, that are required for gene testing using human samples. In February 2019, the Center began providing an assay service using the System as a healthcare service to be assessed,6 and has been putting in place the structures that will provide this testing to the certified quality level in anticipation of greater demand once insurance coverage is granted.
The OncoGuide NCC Oncopanel System for use in cancer genome profiling received approval for insurance coverage on June 1, 2019. As a result, we anticipate an increase in the opportunities for more patients to receive testing. In addition to introducing the System at medical institutions and providing support through RIKEN GENESIS, which is in charge of conducting the testing, we plan to implement a complete domestic testing flow, with detailed support, contributing to the clinical realization of cancer genomic medicine in Japan.
By working to increase testing opportunities for patients and creating high-value testing and diagnosis technologies, going forward Sysmex aims to continue contributing to the development and advancement of personalized medicine.
||Gene mutation analysis set (for use in cancer genome profiling)
||OncoGuide™ NCC Oncopanel System
(medical equipment production sales authorization number: 23000BZX00398000）
||Medical institutions that have in place diagnostic systems appropriate for cancer genome profiling7
||Clinical cancer gene testing:
In recent years, the analysis of a patient’s cancer-specific gene abnormalities by obtaining a tumor’s genomic profile has become a focus in cancer treatment. Such testing is used to provide information that is useful in determining treatment methods, including diagnosis, treatment and the selection of anti-cancer drugs.
Conditions for manufacturing and marketing approval:
A company must take necessary measures to ensure that doctors having sufficient knowledge and experience related to cancer genomic medicine comply with test subjects and timing based on the most recent guidelines of related associations, follow the guidance related to facilities such as core hospitals for cancer genomic medicine, and that healthcare institutions use products under treatment systems based on cancer genome profiling tests.
Precautions concerning target use or indications:
Diagnoses and decisions regarding treatment methods based on results produced by using this product for comprehensive genomic profiling are to be used as part of overall judgments by doctors familiar with cancer genomic medicine based on their latest medical knowledge in combination with a patient’s treatment history, other related test results and clinical symptoms.
||College of American Pathologists (CAP):
CAP accreditation indicates certification of the technological level of a target system through testing and inspection by a clinical testing laboratory. This accreditation certifies that genetic analysis has a technological level sufficiently reliable for submission to the U.S. Food and Drug Administration (FDA).
Clinical Laboratory Improvement Amendment (CLIA):
Laboratories with U.S. CLIA certification are required to undergo periodic inspections to ensure quality maintenance, and having such registration indicates that a lab meets world-class technology standards for quality assurance and sufficient reliability in genetic analysis.
Specialized quality management standard for clinical lab tests.
||Healthcare services to be assessed:
The system targets medical treatments that are under assessment for insurance coverage. Although such advanced healthcare technologies and new drugs are not yet covered by insurance, the working assumption is that they will be in the future. The system covers advanced medical care and the use of medical instruments that have been approved under the Pharmaceutical Affairs Law but have not yet received insurance coverage, as well as the administration of approved drugs that have not yet been included on the National Health Insurance drug price list.
||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:
・ 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
- Information contained in the press release is current as of the date of the announcement,
but may be subject to change without prior notice.