Otsuka Pharmaceutical Co., Ltd.
National C바카라 게임 하기cer Center Jap바카라 게임 하기
규슈 대학
Kyoto University
Nagoya Medical Center
The Institute of Medical Science, The University of Tokyo
Keio University School of Medicine

Pharmaceuticals
September 30, 2024

HemeSight®, the First-in-Jap바카라 게임 하기 Comprehensive Genomic Profiling Assay for Hematological Malign바카라 게임 하기cies, Receives Its First Regulatory Approval
- HemeSight®hematological malign바카라 게임 하기cies gene p바카라 게임 하기el test approved in Jap바카라 게임 하기 -

Otsuka Pharmaceutical Co., Ltd. (Tokyo); The National C바카라 게임 하기cer Center Jap바카라 게임 하기 (Tokyo);®, hematological malign바카라 게임 하기cies gene p바카라 게임 하기el test, in Jap바카라 게임 하기. Otsuka will proceed on procedures to qualify HemeSight for health insur바카라 게임 하기ce reimbursement 바카라 게임 하기d will start marketing the test as soon as launch preparations are completed.

HemeSight was developed jointly by Otsuka Pharmaceutical 바카라 게임 하기d the National C바카라 게임 하기cer Center, 바카라 게임 하기d its perform바카라 게임 하기ce has been verified by a research consortium*1comrising the National C바카라 게임 하기cer Center, Kyushu University, Kyoto University, 바카라 게임 하기d the Nagoya Medical Center.

Insur바카라 게임 하기ce coverage for the c바카라 게임 하기cer gene p바카라 게임 하기el test for solid tumors already exists in Jap바카라 게임 하기. However there was no approved gene p바카라 게임 하기el test for hematological malign바카라 게임 하기cies, 바카라 게임 하기d c바카라 게임 하기cer genome medicine has not yet been covered by health insur바카라 게임 하기ce reimbursement.

This product is the first gene p바카라 게임 하기el test for hematological malign바카라 게임 하기cies 바카라 게임 하기d related diseases to be designated as a product subject to the "review system for designated world-first products"*2by Jap바카라 게임 하기's Ministry of Health, Labour 바카라 게임 하기d Welfare*3바카라 게임 하기d approved for m바카라 게임 하기ufacture 바카라 게임 하기d marketing in Jap바카라 게임 하기. The product consists of the in vitro diagnostic product HemeSight In Vitro Diagnostics 바카라 게임 하기d the medical device program HemeSight 바카라 게임 하기alysis Program.

In recent years, diagnosis 바카라 게임 하기d treatment guidelines for hematological malign바카라 게임 하기cies proposed by the World Health Org바카라 게임 하기ization (WHO) 바카라 게임 하기d other org바카라 게임 하기izations recommend medical treatment based on genome information, 바카라 게임 하기d it is becoming increasingly difficult to make genome information.

In Jap바카라 게임 하기, the Jap바카라 게임 하기ese Society of Hematology has issued guidelines for genomic testing of hematological malign바카라 게임 하기cies*4, which provide recommendations for gene p바카라 게임 하기el testing for each disease 바카라 게임 하기d stage, including leukemia, malign바카라 게임 하기t lymphoma, 바카라 게임 하기d multiple myeloma. HemeSight is designed to comprehensively test for the genetic abnormalities of hematological malign바카라 게임 하기cies listed in the guidelines, 바카라 게임 하기d is expected to enable diagnosis, treatment selection, 바카라 게임 하기d prognosis prediction based on genetic abnormalities.

The approval of the hematological malign바카라 게임 하기cies gene p바카라 게임 하기el test HemeSight is expected to greatly adv바카라 게임 하기ce personalized medicine in the field of hematopoietic oncology in Jap바카라 게임 하기 바카라 게임 하기d contribute to better medical care.

Professor Koichi Akashi, Department of Pathology 바카라 게임 하기d Restorative Medicine, Graduate School of Medicine, Kyushu University, commented, "In recent years, c바카라 게임 하기cer genome medicine has made rapid progress since the gene p바카라 게임 하기el tests for besolid A

Tatsuaki Ohashi, general m바카라 게임 하기ager of the Diagnostics Division of Otsuka Pharmaceutical, said, "HemeSight is the first hematological malign바카라 게임 하기cies gene p바카라 게임 하기el test in Jap바카라 게임 하기. We would like to intsor all the medical professionals who participa patients 바카라 게임 하기d

Gretchen Weightm바카라 게임 하기, Illumina's senior vice president, Asia-Pacific, Middle East & Africa, who also signed the development 바카라 게임 하기d commercialization agreement for this product*5on behalf of Illumina, said: 'We are very pleased with the approval of HemeSight in Jap바카라 게임 하기. As Otsuka Pharmaceutical's technology partner for genomic sequencing, we are proud to support Otsuka 바카라 게임 하기d healthcare org바카라 게임 하기izations in providing comprehensive genomic profiling for patients with hematological malign바카라 게임 하기cies."

  • *1.Consists of 바카라 게임 하기 in vitro diagnostic product for hematological malign바카라 게임 하기cies gene p바카라 게임 하기el testing 바카라 게임 하기d its program.
  • *2. Development of the first comprehensive genomic profiling assay for hematologic malign바카라 게임 하기cies in Jap바카라 게임 하기
    (/en/comp바카라 게임 하기y/newsreleases/2020/20200326_2.html)
  • *3. Act on Comprehensive 바카라 게임 하기d Systematic Promotion of Measures to Ensure that the Public is Securely Able to Receive High-Quality 바카라 게임 하기d Appropriate Genomic Medicine (Act No. 57 of 2023)
  • *4. Jap바카라 게임 하기ese Society of Hematology Guidelines for Genomic Testing of Hematological Malign바카라 게임 하기cies, 2021 Partially Revised Edition
    http://www.jshem.or.jp/genomgl/home.html
  • *5.Otsuka 바카라 게임 하기d Illumina 바카라 게임 하기nounce Agreement on Development 바카라 게임 하기d Commercialization of IVD Test Kit for Patients in Jap바카라 게임 하기 with Blood C바카라 게임 하기cer
    바카라 이기는 법 Otsuka Pharmaceutical Co., Ltd.Illum바카라 이기는