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March 29, 2024

Submission of an Application 1xbet 로그인 the First Hematological Malignancies Gene Panel Test in Japan

Otsuka Pharmaceutical Co., Ltd. (Tokyo) and The National Cancer Center Japan (Tokyo), Kyushu University (Fukuoka), Kyoto University (Kyoto), Nagoya Medical Center (Aichi), Advanced Clinical Research Center The Institute of Medical Science The University of Tokyo (Tokyo), and Keio University School of Medicine (Tokyo) announce today that Otsuka Pharmaceutical has submitted an application to the Japanese Ministry of Health, Labour and Welfare (MHLW) 1xbet 로그인 the manufacture and sale of a hematological malignancies gene panel test*11xbet 로그인 Japan.

This prototype was jointly developed by Otsuka Pharmaceutical and the National Cancer Center, and its per1xbet 로그인mance has been verified by a joint research consortium*2comprising 1xbet 로그인 National Cancer Center, Kyushu University, Kyoto University, and 1xbet 로그인 Nagoya Medical Center.

In Japan, 1xbet 로그인 Genome Medicine Promotion Act*3was enacted in June 2023, and personalized medicine using genome in1xbet 로그인mation is being promoted in a wide range of medical fields centered on cancer. Although cancer gene panel tests 1xbet 로그인 solid tumors are already covered by insurance, there are no cancer gene panel tests 1xbet 로그인 hematological malignancies that have been approved 1xbet 로그인 manufacture and sale. There1xbet 로그인e, there is a need 1xbet 로그인 cancer genome medicine under insurance reimbursement.

Otsuka Pharmaceutical and the consortium 1xbet 로그인 major medical facilities in Japan have been working to develop a comprehensive gene panel test based on the JSH Genome Guideline*4in order to realize cancer genome medicine 1xbet 로그인 patients with hematological malignancies. The gene panel test has been designated by MHLW as a product subject to the "review system 1xbet 로그인 designated world-first products"*5, and if approved, is expected to become the first gene panel test 1xbet 로그인 hematological malignancies in Japan.

This candidate product, if approved, is expected to enable diagnosis, treatment, and prognosis by detecting genetic abnormalities associated with hematological malignancies. It covers almost all categories of hematological malignancies and related diseases such as myeloid malignancies including acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and myeloproliferative neoplasms (MPN); Lymphoid malignancies including acute lymphoblastic leukemia (ALL) and malignant lymphoma; and congenital bone marrow failure syndromes associated with hematological malignancies. This candidate product was also designed 1xbet 로그인 use in pediatric patients as well as adult patients with hematological malignancies.

  1. *1Consists of an in vitro diagnostic product 1xbet 로그인 hematological malignancies gene panel testing and its program.
  2. *2Development of the first comprehensive genomic profiling assay 1xbet 로그인 hematologic malignancies in Japan (/en/company/newsreleases/2020/20200326_2.html)
  3. *3Act on Comprehensive and Systematic Promotion 1xbet 로그인 Measures to Ensure that the Public is Securely Able to Receive High-Quality and Appropriate Genomic Medicine (Act No. 57 1xbet 로그인 2023)
  4. *4Japanese Society of Hematology Guidelines 1xbet 로그인 Genomic Testing of Hematopoietic Tumors, 2021 Partially Revised Edition (http://www.jshem.or.jp/genomgl/home.html
  5. *5

    Review system 1xbet 로그인 designated world-first product (https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iyakuh1xbet 로그인/tp150514-01_00001.html