On January 31, 2019, Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) launched the OncoGuide™ NCC Oncopanel System (generic name: genetic mutation analysis set (for cancer genome profiling)), for which the Company received manufacturing and marketing approval on December 25, 2018.
Accordingly, in February 2019 Sysmex’s subsidiary, RIKEN GENESIS Co., Ltd. (HQ: Shinagawa-ku, Tokyo, Japan; President & CEO: Naoto Kondo), will begin providing an assay service as a healthcare service to be assessed1 using the OncoGuide™ NCC Oncopanel System and next-generation sequencers.2
On December 25, 2018, Sysmex received manufacturing and marketing approval in Japan for the first time for the OncoGuide™ NCC Oncopanel System, a combination medical device3 comprising the OncoGuide™ NCC Oncopanel Analysis Program and the OncoGuide™ NCC Oncopanel Kit, to be used in cancer genome profiling.
Previously, on April 1, 2018, the Multiplex Gene Panel Testing to Advance Personalized Medicine was approved as Advanced Medical Care.4 This testing involved using the OncoGuide™ NCC Oncopanel System (prior to obtaining manufacturing and marketing approval) and next-generation sequencers on 350 cases at 50 institutions, including 11 core hospitals for cancer genomic medicine and affiliated hospitals. Measurement was performed on all samples taken in this testing at the RIKEN GENESIS Innovation Genome Center (Kawasaki Office).
Sysmex launched the OncoGuide™ NCC Oncopanel System on January 31, 2019, and in February 2019 RIKEN GENESIS will begin providing an assay service as evaluation treatment using the OncoGuide™ NCC Oncopanel System and next-generation sequencers.
Sysmex is applying for health insurance coverage of this system in order to increase opportunities for patients to receive testing. Going forward, we will work toward the earliest possible provision of complete domestic services related to new cancer diagnostic methods, with the aim of contributing to the advancement of healthcare.
||Conditions for Manufacturing and Marketing Approval for OncoGuide™ NCC Oncopanel System:
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.
||Press release dated December 25, 2018, “Sysmex Receives Manufacturing and Marketing Approval to Use the OncoGuide™ NCC Oncopanel System in Cancer Genome Profiling:”
||Healthcare services to be assessed:
A type of healthcare system approved for use in combination with healthcare services covered by insurance. 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.
An analyzer for reading large volumes of DNA base sequences.
||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.
||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.
- Information contained in the press release is current as of the date of the announcement,
but may be subject to change without prior notice.