Otsuka Pharmaceutical Co., Ltd.

November 2, 2021

Otsuka Measurement Kit to Assist in Diagnosis and to Monitor Treatment Effectiveness
for Acute Lymphoblastic Leukemia (ALL), to be Covered by Health Insurance in Japan

  • First-in-Japan, minor BCR-ABL mRNA-based measurement kit for ALL
  • Covered by health insurance system as of November 1

Otsuka Pharmaceutical Co., Ltd. announces that it has received notification that as of November 1 insurance coverage is to be provided by the National Health Insurance system in Japan for use of the Otsuka minor BCR-ABL mRNA measurement kit as an in-vitro diagnostic product.


The kit is the first in-vitro, minor BCR-ABL mRNA diagnostic pharmaceutical product in Japan to support diagnosis and to monitor treatment effectiveness for Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL). Otsuka expects that the kit can support identification of the most appropriate treatment opportunities for patients in Japan with ALL.

In patients with ALL, lymphocytes (a type of white blood cell) become malignant at an early stage of differentiation and proliferate unrestrainedly without maturing into functional lymphocytes. Early diagnosis and treatment initiation are important because symptoms can appear suddenly and the condition progresses rapidly. The number of patients in Japan was reported to be about 5,000 in a survey by the Japanese MHLW in 2017.

The Diagnostic Division of Otsuka has launched Otsuka's WT1 mRNA Measurement Kit II Otsuka and Major BCR-ABL mRNA Measurement Kit Otsuka as in-vitro diagnostic agents for blood cancers. Otsuka will continue to contribute to medical treatment with the aim of developing diagnostic agents that can maximize the capabilities of therapeutic agents.