Sysmex’s OncoGuide™ NCC Oncopanel System receives insurance coverage

Sysmex Corporation announces that the OncoGuide™ NCC Oncopanel System is now covered by health insurance in Japan as a companion diagnostic for futibatinib, a treatment for unresectable biliary tract cancer harboring FGFR2 gene fusions that has progressed after chemotherapy. Futibatinib was developed by Taiho Pharmaceutical Co., Ltd.. Riken Genesis Co., Ltd, a subsidiary of Sysmex, will begin assay services in Japan corresponding to this insurance coverage from September 2023.

Biliary tract cancer develops in approximately 26,000 patients annually in Japan. With a five-year survival rate of less than 30%, it has the second poorest cancer prognosis after pancreatic cancer. Currently, few treatment options exist for this disease, and no standard treatment has been established for locally advanced or metastatic biliary tract cancer that has progressed after first-line treatment. To address this, the development of molecular-targeted therapeutic agents targeting specific genetic abnormalities is actively underway.

In December 2018, the System received manufacturing and marketing approval in Japan as the country’s first cancer genome profiling test and obtained insurance coverage in June 2019. Sysmex has contributed to the promotion of cancer genomic medicine in Japan with a testing flow that can be conducted entirely within the country. Furthermore, Sysmex has been working with Taiho Pharmaceutical to develop a companion diagnostic for futibatinib. On February 28, 2023, Sysmex received approval for a partial change to the System to assist in identifying patients with biliary tract cancer eligible for futibatinib treatment. On June 26, Taiho Pharmaceutical received manufacturing and marketing approval for futibatinib in Japan, and the drug was listed in the NHI price list on August 30, 2023.

The System has now received insurance coverage as a new companion diagnostic for futibatinib in biliary tract cancer, in addition to its previously approved use for cancer genome profiling. Accordingly, Riken Genesis will begin providing assay services for this insurance-covered testing under quality assurance in accordance with international standards from September 2023. This will enable the identification of eligibility for futibatinib under insurance coverage and is expected to provide a new treatment option for patients with biliary tract cancer in the future.

Sysmex will continue its effort to create high-value testing and diagnostic technologies that support optimal healthcare for individual patients by collaborating with diverse stakeholders so that they can have a better healthcare journey.

Overview of the product and insurance coverage

MB Bureau