Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that the hematological tumor gene panel test HemeSite^®, the first-in-Japan, comprehensive genomic profiling assay for hematological malignancies, is covered by Japan's national health insurance system, effective March 1. Sales have commenced today.

In recent years, classification and diagnostic criteria for hematological malignancies from the World Health Organization (WHO), as well as clinical treatment guidelines from medical societies around the world, highlight the critical importance of medical treatment based on genome information, making this information essential for the latest medical treatment.

In Japan, the usefulness of genomic information for diagnosis, treatment selection, and prognosis prediction is described in the Japanese Society of Hematology Genome Guidelines^*1.

Insurance coverage for the cancer gene panel test for solid tumors exists in Japan, but until now insurance reimbursement has not been provided to any gene panel test for hematological malignancies.

HemeSight was developed jointly by Otsuka and the National Cancer Center Japan. Its performance has been verified by a research consortium^*2 comprising the National Cancer Center, Kyushu University, Kyoto University, Nagoya Medical Center, the Institute of Medical Science at the University of Tokyo, and Keio University School of Medicine.

In hematological malignancies, genomic information is useful for treatment selection and for diagnosis and prognosis prediction, therefore the use of gene panel testing at the time of initial diagnosis is recommended in the Genome Medicine Promotion Act. From now on, the initial diagnosis of leukemia such as acute myeloid leukemia, malignant lymphoma, and multiple myeloma is covered by insurance. Accordingly, in the case of acute myeloid leukemia, HemeSight can be used for prognosis prediction based on genetic abnormalities and in the case of malignant lymphoma and multiple myeloma, it can be used for diagnosis when conventional methods cannot be used or when it is difficult to distinguish from other diseases.

In addition, diseases such as acute myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia are also covered by insurance when they recur or are refractory. Also, the start of insurance coverage may be beneficial to patients with unexplained, significant decreases in blood cells, for whom it has been difficult to determine treatment plans because definitive diagnoses could not be made.

The launch of the hematological tumor gene panel test HemeSight is expected to advance the social implementation of personalized medicine for hematological tumors in Japan.

Product Overview

The hematological tumor gene panel test HemeSight is composed of the in vitro diagnostic drug HemeSight Diagnostic Drug and the medical device program HemeSight Analysis Program.

*1 Japanese Society of Hematology Guidelines for Genomic Testing of Hematological Malignancies, 2021 Partially Revised Edition　（http://www.jshem.or.jp/genomgl/home.html）

*2 Consists of an in vitro diagnostic product for hematological malignancies gene panel testing and its program.