Nichirei Biosciences and Leica Biosystems Partner to Expand Access to Precision Oncology Through ALK Companion Diagnostic (CDx) Development
TOKYO, JAPAN, March 31, 2026 – Leica Biosystems, a Danaher company and a global leader in anatomic pathology solutions, and Nichirei Biosciences Inc. today announce they have entered into a partnership agreement for the joint development of a companion diagnostic (CDx) reagent intended for the detection of ALK fusion protein in patients with non‑small cell lung cancer (NSCLC) in Japan.
As precision medicine continues to advance—particularly in oncology, where therapeutic decisions increasingly depend on biomarker status—companion diagnostics play an essential role in helping pathologists identify patients who may benefit from targeted therapies. At the same time, there is a growing need for solutions that can be efficiently integrated into routine pathology workflows, supporting automation, consistency, and operational simplicity to enable broader adoption.
Nichirei Biosciences has a proven track record of launching companion diagnostics (CDx) on the Japanese market for the detection of ALK fusion proteins in patients with non-small cell lung cancer (NSCLC) using its immunostaining system. The companion diagnostic reagent will be jointly developed for compatibility with the Leica Biosystems BOND-III fully automated IHC and ISH stainer. It aims to help translate ALK biomarker status into actionable treatment decisions within routine pathology workflows.
“Companion diagnostics are essential to ensuring patients are connected to the therapies most likely to benefit them,” said Hiroharu Okochi, Japan General Manager at Leica Biosystems. “By partnering with Nichirei Biosciences, we are advancing a companion diagnostic solution designed for automated, routine pathology workflows—supporting reliable clinical application while maintaining consistency, efficiency, and scalability in the laboratory.”
By leveraging the complementary expertise of Nichirei Biosciences in companion diagnostic reagent development and Leica Biosystems in automated immunostaining technology, the companies aim to provide companion diagnostic agents that contribute to the advancement of precision cancer therapy in Japan.
About Nichirei Biosciences Inc.
Nichirei Biosciences leverages the Nichirei Group’s strengths in materials procurement and its technological capabilities in biotechnology to operate in three business areas: molecular diagnostic reagents, rapid diagnostic reagents, and biopharmaceutical raw materials. Utilizing our accumulated technological capabilities, procurement strength, and quality assurance, we aim to contribute to the advancement of the medical, health, and biotechnology industries by delivering high‑quality products and services.
About Leica Biosystems
Leica Biosystems is a cancer diagnostics company and a global leader in anatomic and digital pathology solutions. The company offers a comprehensive product range for each step in the pathology process, from sample preparation and staining to imaging and reporting. As the only company to own the full workflow from biopsy to diagnosis, Leica Biosystems is uniquely positioned to break down the barriers between each step. The company’s mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of its corporate culture. Leica Biosystems is proud to be a Danaher Corporation subsidiary.
About Danaher
Danaher is a leading global life sciences and diagnostics innovator, committed to accelerating the power of science and technology to improve human health. Our businesses partner closely with customers to solve many of the most important health challenges impacting patients around the world. Danaher's advanced science and technology - and proven ability to innovate - help enable faster, more accurate diagnoses and help reduce the time and cost needed to sustainably discover, develop and deliver life-changing therapies. Focused on scientific excellence, innovation and continuous improvement, our approximately 63,000 associates worldwide help ensure that Danaher is improving quality of life for billions of people today, while setting the foundation for a healthier, more sustainable tomorrow. Explore more at www.danaher.com.
