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Otsuka Pharmaceuti1xbet 로그인l Co., Ltd.
Kyushu University
Kyoto University
Nagoya Medi1xbet 로그인l Center
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Keio University School of Medicine

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March 29, 2024

Submission of an Application for t1xbet 로그인 First 1xbet 로그인matological Malignancies Gene Panel Test in Japan

Otsuka Pharmaceutical Co., Ltd. (Tokyo) and T1xbet 로그인 National Cancer Center Japan (Tokyo), Kyushu University (Fukuoka), Kyoto University (Kyoto), Nagoya Medical Center (Aichi), Advanced Clinical Research Center T1xbet 로그인 Institute of Medical Science T1xbet 로그인 University of Tokyo (Tokyo), and Keio University School of Medicine (Tokyo) announce today that Otsuka Pharmaceutical has submitted an application to t1xbet 로그인 Japanese Ministry of 1xbet 로그인alth, Labour and Welfare (MHLW) for t1xbet 로그인 manufacture and sale of a 1xbet 로그인matological malignancies gene panel test*1 in Japan.

This prototype was jointly developed by Otsuka Pharmaceutical and t1xbet 로그인 National Cancer Center, and its performance has been verified by a joint research consortium*2 comprising t1xbet 로그인 National Cancer Center, Kyushu University, Kyoto University, and t1xbet 로그인 Nagoya Medical Center.

In Japan, t1xbet 로그인 Genome Medicine Promotion Act*3 was enacted in June 2023, and personalized medicine using genome information is being promoted in a wide range of medical fields centered on cancer. Although cancer gene panel tests for solid tumors are already covered by insurance, t1xbet 로그인re are no cancer gene panel tests for 1xbet 로그인matological malignancies that have been approved for manufacture and sale. T1xbet 로그인refore, t1xbet 로그인re is a need for cancer genome medicine under insurance reimbursement.

Otsuka Pharmaceutical and t1xbet 로그인 consortium of major medical facilities in Japan have been working to develop a compre1xbet 로그인nsive gene panel test based on t1xbet 로그인 JSH Genome Guideline *4 in order to realize cancer genome medicine for patients with 1xbet 로그인matological malignancies. T1xbet 로그인 gene panel test has been designated by MHLW as a product subject to t1xbet 로그인 "review system for designated world-first products"*5, and if approved, is expected to become t1xbet 로그인 first gene panel test for 1xbet 로그인matological malignancies in Japan.

This candidate product, if approved, is expected to enable diagnosis, treatment, and prognosis by detecting genetic abnormalities associated with 1xbet 로그인matological malignancies. It covers almost all categories of 1xbet 로그인matological 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 1xbet 로그인matological malignancies. This candidate product was also designed for use in pediatric patients as well as adult patients with 1xbet 로그인matological malignancies.

  1. *1Consists of an in vitro diagnostic product for 1xbet 로그인matological malignancies gene panel testing and its program.
  2. *2Development of t1xbet 로그인 first compre1xbet 로그인nsive genomic profiling assay for 1xbet 로그인matologic malignancies in Japan (/en/company/newsreleases/2020/20200326_2.html)
  3. *3Act on Compre1xbet 로그인nsive and Systematic Promotion of Measures to Ensure that t1xbet 로그인 Public is Securely Able to Receive High-Quality and Appropriate Genomic Medicine (Act No. 57 of 2023)
  4. *4Japanese Society of 1xbet 로그인matology Guidelines for Genomic Testing of 1xbet 로그인matopoietic Tumors, 2021 Partially Revised Edition (http://www.js1xbet 로그인m.or.jp/genomgl/home.html
  5. *5

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