Otsuka Pharmaceutical Co., Ltd.
Kyushu University
Kyoto University
Nagoya Medical Center
The Institute of Medical Science The University of Tokyo
Keio University School of Medicine

March 29, 2024

Submission of an Application for 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) for the manufacture and sale of a hematological malignancies gene panel test*1 in Japan.

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

In Japan, the 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, there are no cancer gene panel tests for hematological malignancies that have been approved for manufacture and sale. Therefore, there is a need for cancer genome medicine under insurance reimbursement.

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

  1. *1Consists of an in vitro diagnostic product for hematological malignancies gene panel testing and its program.
  2. *2Development of the first comprehensive genomic profiling assay for hematologic malignancies in Japan (
  3. *3Act on Comprehensive and Systematic Promotion of Measures to Ensure that the Public is Securely Able to Receive High-Quality and Appropriate Genomic Medicine (Act No. 57 of 2023)
  4. *4Japanese Society of Hematology Guidelines for Genomic Testing of Hematopoietic Tumors, 2021 Partially Revised Edition (
  5. *5

    Review system for designated world-first product (