Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that the comprehensive genomic profiling assay for hematologic malignancies, developed by Otsuka and the National Cancer Center Japan, has been granted the SAKIGAKE designation by Japan's Ministry of Health, Labour and Welfare.

An evaluation of this assay is underway by a consortium comprising the National Cancer Center Japan and several major medical facilities in Japan.

The SAKIGAKE (forerunner initiative) Designation System aims to advance early practical applications for innovative new medicines and other products. In principle, designated product must have the potential for novel treatment effectiveness or reduction in symptoms based on a different mechanism of action from already approved products. Designated products are eligible for prioritized consultation services and reviews for regulatory authorizations.

This is the first comprehensive genomic profiling assay developed in Japan for hematologic malignancies. Unlike existing gene panel tests for solid tumors, for this assay DNA and RNA extracted from peripheral blood, bone marrow fluid, lymphoid tissue, etc. are used as measurement samples. Clinically useful genetic abnormalities in hematopoietic tumors are detected based on the Hemotological Society of Japan's Hematopoietic Cancer Genome Testing Guidelines.

This assay covers almost all categories of hematologic malignancies: myeloid malignancies such as acute myeloid leukemia, myelodysplastic syndrome, and myeloproliferative neoplasm; lymphoid malignancies such as acute lymphoblastic leukemia, lymphoma, and myeloma; and congenital bone marrow failure syndromes. This assay will provide a valuable information for clinicians and patients in diagnosis, treatment, and prognostic prediction.