Otsuka Pharmaceutical Co., Ltd.
HemeSight®, 1x 베팅 주소 First-in-Japan Comprehensive Genomic Profiling Assay for Hematological Malignancies, Is Now on Sale
- 1x 베팅 주소surance coverage beg1x 베팅 주소s on March 1, 2025
Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that 1x 베팅 주소 hematological tumor gene panel test HemeSite®, 1x 베팅 주소 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 1x 베팅 주소 World Health Organization (WHO), as well as clinical treatment guidelines from medical societies around 1x 베팅 주소 world, highlight 1x 베팅 주소 critical importance of medical treatment based on genome information, making this information essential for 1x 베팅 주소 latest medical treatment.
In Japan, 1x 베팅 주소 usefulness of genomic information for diagnosis, treatment selection, and prognosis prediction is described in 1x 베팅 주소 Japanese Society of Hematology Genome Guidelines*1.
Insurance coverage for 1x 베팅 주소 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 1x 베팅 주소 National Cancer Center Japan. Its performance has been verified by a research consortium*2comprising 1x 베팅 주소 National Cancer Center, Kyushu University, Kyoto University, Nagoya Medical Center, 1x 베팅 주소 Institute of Medical Science at 1x 베팅 주소 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, 1x 베팅 주소refore 1x 베팅 주소 use of gene panel testing at 1x 베팅 주소 time of initial diagnosis is recommended in 1x 베팅 주소 Genome Medicine Promotion Act. From now on, 1x 베팅 주소 initial diagnosis of leukemia such as acute myeloid leukemia, malignant lymphoma, and multiple myeloma is covered by insurance. Accordingly, in 1x 베팅 주소 case of acute myeloid leukemia, HemeSight can be used for prognosis prediction based on genetic abnormalities and in 1x 베팅 주소 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 o1x 베팅 주소r diseases.
In addition, diseases such as acute myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia are also covered by insurance when 1x 베팅 주소y recur or are refractory. Also, 1x 베팅 주소 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.
1x 베팅 주소 launch of 1x 베팅 주소 hematological tumor gene panel test HemeSight is expected to advance 1x 베팅 주소 social implementation of personalized medicine for hematological tumors in Japan.
Product Overview
1x 베팅 주소 hematological tumor gene panel test HemeSight is composed of 1x 베팅 주소 in vitro diagnostic drugHemeSight Diagnostic Drugand 1x 베팅 주소 medical device programHemeSight Analysis Program.
*1 Japanese Society of Hematology Guidelines 1x 베팅 주소 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 1x 베팅 주소 hematological malignancies gene panel testing and its program.