Sysmex receives manufacturing and marketing approval to use OncoGuide

Sysmex Corporation has received manufacturing and marketing approval in Japan for the first time for the OncoGuide NCC Oncopanel System, which the company developed jointly with the National Cancer Center (Tokyo, Japan), to be used in cancer genome profiling. The system constitutes a combination medical device comprising the OncoGuide NCC Oncopanel Analysis Program and the OncoGuide NCC Oncopanel Kit and is used in combination with a next-generation sequencer. 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, they used the OncoGuide NCC Oncopanel 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, Labor and Welfare’s Sakigake Designation of the system and a next-generation sequencer used in combination with the System, as in vitro diagnostic pharmaceutical and medical devices. They obtained this designation on February 28, 2017. Thereafter, Sysmex completed development of the System as a combination medical device and applied for manufacturing and marketing approval in June 2018. The company has 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). To expand opportunities for patients to receive this testing, the company plans to apply for health insurance coverage for the System. Its aims are to deliver a new method for diagnosing cancer as quickly as possible and to promote the advancement of healthcare.