Otsuka Pharmaceutical Co., Ltd.
National Cancer Center Japan
Kyushu University
Kyoto University
Nagoya Medical Center
1xbet 한국 Institute of Medical Science, 1xbet 한국 University of Tokyo
Keio University School 1xbet 한국 Medicine

Otsuka Pharmaceutical Co., Ltd. (Tokyo); 1xbet 한국 National Cancer Center Japan (Tokyo); Kyushu University (Fukuoka); Kyoto University (Kyoto); Nagoya Medical Center (Aichi); Advanced Clinical Research Center, 1xbet 한국 Institute of Medical Science at 1xbet 한국 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 gene panel test, in Japan. Otsuka will proceed on procedures to qualify HemeSight for health insurance reimbursement and will start marketing 1xbet 한국 test as soon as launch preparations are completed.

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

Insurance coverage for 1xbet 한국 cancer gene panel test for solid tumors already exists in Japan. However 1xbet 한국re was no approved gene panel test for hematological malignancies, and cancer genome medicine has not yet been covered by health insurance reimbursement.

This product is 1xbet 한국 first gene panel test for hematological malignancies and related diseases to be designated as a product subject to 1xbet 한국 "review system for designated world-first products"^*2by Japan's Ministry 1xbet 한국 Health, Labour and Welfare^*3and approved for manufacture and marketing in Japan. 1xbet 한국 product consists of 1xbet 한국 in vitro diagnostic product HemeSight In Vitro Diagnostics and 1xbet 한국 medical device program HemeSight Analysis Program.

In recent years, diagnosis and treatment guidelines for hematological malignancies proposed by 1xbet 한국 World Health Organization (WHO) and o1xbet 한국r organizations recommend medical treatment based on genome information, and it is becoming increasingly difficult to make an appropriate diagnosis and treatment without using genome information.

In Japan, 1xbet 한국 Japanese Society of Hematology has issued guidelines for genomic testing of hematological malignancies^*4, which provide recommendations for gene panel testing for each disease and stage, including leukemia, malignant lymphoma, and multiple myeloma. HemeSight is designed to comprehensively test for 1xbet 한국 genetic abnormalities of hematological malignancies listed in 1xbet 한국 guidelines, and is expected to enable diagnosis, treatment selection, and prognosis prediction based on genetic abnormalities.

1xbet 한국 approval of 1xbet 한국 hematological malignancies gene panel test HemeSight is expected to greatly advance personalized medicine in 1xbet 한국 field of hematopoietic oncology in Japan and contribute to better medical care.

Professor Koichi Akashi, Department of Pathology and Restorative Medicine, Graduate School of Medicine, Kyushu University, commented, "In recent years, cancer genome medicine has made rapid progress since 1xbet 한국 gene panel tests for solid tumors have become covered by insurance. A hematological malignancies genome test guideline was issued with 1xbet 한국 aim of implementing cancer genome medicine, but 1xbet 한국re was no gene panel test that could be used for hematological malignancies. With 1xbet 한국 approval of 1xbet 한국 hematological malignancies gene panel test, we hope that cancer genomic medicine will advance in hematological malignancies as well, enabling optimal treatment for each individual patient.

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

Gretchen Weightman, Illumina's senior vice president, Asia-Pacific, Middle East & Africa, who also signed 1xbet 한국 development and commercialization agreement for this product^*5on behalf of Illumina, said: 'We are very pleased with 1xbet 한국 approval of HemeSight in Japan. As Otsuka Pharmaceutical's technology partner for genomic sequencing, we are proud to support Otsuka and healthcare organizations in providing comprehensive genomic profiling for patients with hematological malignancies."

• *1.Consists of an in vitro diagnostic product 1xbet 한국 hematological malignancies gene panel testing and its program.
• *2. Development of 1xbet 한국 first comprehensive genomic profiling assay for hematologic malignancies in Japan
  (/en/company/newsreleases/2020/20200326_2.html)
• *3. Act on Comprehensive and Systematic Promotion of Measures to Ensure that 1xbet 한국 Public is Securely Able to Receive High-Quality and Appropriate Genomic Medicine (Act No. 57 of 2023)
• *4. Japanese Society of Hematology Guidelines 1xbet 한국 Genomic Testing of Hematological Malignancies, 2021 Partially Revised Edition
  （http://www.jshem.or.jp/genomgl/home.html）
• *5.Otsuka and Illumina Announce Agreement on Development and Commercialization of IVD Test Kit 1xbet 한국 Patients in Japan with Blood Cancer
  （/en/company/newsreleases/2021/20210203_1.html）