Otsuka Pharmaceutical Co., Ltd.
Illumina, Inc.

February 3, 2021

Otsuka and Illumina Announce Agreement on Development and Commercialization of IVD Test Kit for Patients in Japan with Blood Cancer

First use in Japan of a comprehensive genomic profiling assay for blood cancers

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Illumina, Inc. (Illumina; based in San Diego, Calif.) announce a collaboration to develop an in-vitro, diagnostic (IVD) genomic profiling testing kit for patients in Japan blood cancers.

Under the agreement, Otsuka will develop IVD tests, based on a genomic profiling assay in development, that will run on Illumina's NextSeq™ 550Dx system.

Otsuka and Illumina's broad objective is to accelerate research and development that will provide clinical benefits such as more decisive information related to diagnosis, prognostic prediction and treatment--to both patients and health care providers. If Japan's regulatory authority approves the test, kit, the next-generation-sequencing (NGS)-based, IVD workflow will enhance patient access to genetic information and personalized medicine. Contingent on this approval, Otsuka will commercialize the test kit in Japan.

As additional information on the NextSeq™ 550Dx sequencing system, in 2018 Illumina received product approval for it in Japan as a medical device. Since 2018, Illumina has been expanding its IVD portfolio in the country.

As additional background on the genomic profiling assay in development by Otsuka and the National Cancer Center of Japan, in early 2020 the company announced a research collaboration with the Center and several major hospitals in Japan to evaluate the assay. Notably, in 2020 the assay received the Japanese MHLW's SAKIGAKE (forerunner initiative) designation.