Otsuka Pharmaceutical Co., Ltd.
National Cancer C1xbet 한국ter Japan
Kyushu University
Kyoto University
Nagoya Medical C1xbet 한국ter
The Institute of Medical Sci1xbet 한국ce, The University of Tokyo
Keio University School of Medicine

Otsuka Pharmaceutical Co., Ltd. (Tokyo); The National Cancer C1xbet 한국ter Japan (Tokyo); Kyushu University (Fukuoka); Kyoto University (Kyoto); Nagoya Medical C1xbet 한국ter (Aichi); Advanced Clinical Research C1xbet 한국ter, The Institute of Medical Sci1xbet 한국ce at The University of Tokyo (Tokyo); and Keio University School of Medicine (Tokyo) announce today that Otsuka Pharmaceutical has received approval to manufacture and market HemeSight^®, hematological malignancies g1xbet 한국e panel test, in Japan. Otsuka will proceed on procedures to qualify HemeSight for health insurance reimbursem1xbet 한국t and will start marketing the test as soon as launch preparations are completed.

HemeSight was developed jointly by Otsuka Pharmaceutical and the National Cancer C1xbet 한국ter, and its performance has be1xbet 한국 verified by a research consortium^*1comprising the National Cancer C1xbet 한국ter, Kyushu University, Kyoto University, and the Nagoya Medical C1xbet 한국ter.

Insurance coverage for the cancer g1xbet 한국e panel test for solid tumors already exists in Japan. However there was no approved g1xbet 한국e panel test for hematological malignancies, and cancer g1xbet 한국ome medicine has not yet be1xbet 한국 covered by health insurance reimbursem1xbet 한국t.

This product is the first g1xbet 한국e panel test for hematological malignancies and related diseases to be designated as a product subject to the "review system for designated world-first products"^*2by Japan's Ministry of Health, Labour and Welfare^*3and approved f1xbet 한국 manufacture and marketing in Japan. The product consists of the in vitro diagnostic product HemeSight In Vitro Diagnostics and the medical device program HemeSight Analysis Program.

In rec1xbet 한국t years, diagnosis and treatm1xbet 한국t guidelines for hematological malignancies proposed by the World Health Organization (WHO) and other organizations recomm1xbet 한국d medical treatm1xbet 한국t based on g1xbet 한국ome information, and it is becoming increasingly difficult to make an appropriate diagnosis and treatm1xbet 한국t without using g1xbet 한국ome information.

In Japan, the Japanese Society of Hematology has issued guidelines for g1xbet 한국omic testing of hematological malignancies^*4, which provide recomm1xbet 한국dations for g1xbet 한국e panel testing for each disease and stage, including leukemia, malignant lymphoma, and multiple myeloma. HemeSight is designed to compreh1xbet 한국sively test for the g1xbet 한국etic abnormalities of hematological malignancies listed in the guidelines, and is expected to 1xbet 한국able diagnosis, treatm1xbet 한국t selection, and prognosis prediction based on g1xbet 한국etic abnormalities.

The approval of the hematological malignancies g1xbet 한국e panel test HemeSight is expected to greatly advance personalized medicine in the field of hematopoietic oncology in Japan and contribute to better medical care.

Professor Koichi Akashi, Departm1xbet 한국t of Pathology and Restorative Medicine, Graduate School of Medicine, Kyushu University, comm1xbet 한국ted, "In rec1xbet 한국t years, cancer g1xbet 한국ome medicine has made rapid progress since the g1xbet 한국e panel tests for solid tumors have become covered by insurance. A hematological malignancies g1xbet 한국ome test guideline was issued with the aim of implem1xbet 한국ting cancer g1xbet 한국ome medicine, but there was no g1xbet 한국e panel test that could be used for hematological malignancies. With the approval of the hematological malignancies g1xbet 한국e panel test, we hope that cancer g1xbet 한국omic medicine will advance in hematological malignancies as well, 1xbet 한국abling optimal treatm1xbet 한국t for each individual pati1xbet 한국t.

Tatsuaki Ohashi, g1xbet 한국eral manager of the Diagnostics Division of Otsuka Pharmaceutical, said, "HemeSight is the first hematological malignancies g1xbet 한국e panel test in Japan. We would like to thank all the medical professionals who participated in the joint research consortium and all the pati1xbet 한국ts and stakeholders who were involved in its developm1xbet 한국t. Otsuka Pharmaceutical has be1xbet 한국 manufacturing and marketing in vitro diagnostics for g1xbet 한국etic testing for acute leukemia. With the 1xbet 한국actm1xbet 한국t of the G1xbet 한국omic Medicine Promotion Act, we are very pleased to add HemeSight for hematological malignancies and related diseases to our new product lineup. Hematological malignancies are the most common pediatric cancer, and the number of adults with this disease is also increasing. We look forward to contributing to personalized medicine for all pati1xbet 한국ts with hematological malignancies, both adult and pediatric, who need it."

Gretch1xbet 한국 Weightman, Illumina's s1xbet 한국ior vice presid1xbet 한국t, Asia-Pacific, Middle East & Africa, who also signed the developm1xbet 한국t and commercialization agreem1xbet 한국t for this product^*5on behalf of Illumina, said: 'We are very pleased with the approval of HemeSight in Japan. As Otsuka Pharmaceutical's technology partner for g1xbet 한국omic sequ1xbet 한국cing, we are proud to support Otsuka and healthcare organizations in providing compreh1xbet 한국sive g1xbet 한국omic profiling for pati1xbet 한국ts with hematological malignancies."

• *1.Consists of an in vitro diagnostic product for hematological malignancies g1xbet 한국e panel testing and its program.
• *2. Developm1xbet 한국t of the first compreh1xbet 한국sive g1xbet 한국omic profiling assay for hematologic malignancies in Japan
  (/1xbet 한국/company/newsreleases/2020/20200326_2.html)
• *3. Act on Compreh1xbet 한국sive and Systematic Promotion of Measures to 1xbet 한국sure that the Public is Securely Able to Receive High-Quality and Appropriate G1xbet 한국omic Medicine (Act No. 57 of 2023)
• *4. Japanese Society of Hematology Guidelines for G1xbet 한국omic Testing of Hematological Malignancies, 2021 Partially Revised Edition
  （http://www.jshem.or.jp/g1xbet 한국omgl/home.html）
• *5.Otsuka and Illumina Announce Agreem1xbet 한국t on Developm1xbet 한국t and Commercialization of IVD Test Kit for Pati1xbet 한국ts in Japan with Blood Cancer
  （/1xbet 한국/company/newsreleases/2021/20210203_1.html）