
We are pleased to announce that Guardant Health Japan has received approval from Ministry of Health, Labour and Welfare of Japan for Guardant360® CDx liquid biopsy as a companion diagnostic for trastuzumab deruxtecan (recombinant) in advanced solid tumors with ERBB2 copy number alteration (HER2 gene amplification positive). Daiichi Sankyo Co., Ltd. is currently seeking partial approval changes for this use.
Amplification of the ERBB2 gene, a known oncogenic driver, is more commonly observed in breast and gastric cancers in Japan, but can be present across solid tumors. In an analysis of 50,000 patient cases that underwent cancer genomic profiling conducted by National Cancer Center Japan (February 2024), ERBB2 amplifications were identified as the most frequent type of copy number alteration.
Anti-HER2 therapy is currently used in Japan to treat breast, gastric, lung, salivary gland, and colorectal cancers. However, it is not used for other solid cancers showing ERBB2 copy number alterations (HER2 gene amplification positive). Advancing the insurance coverage process for Guardant360® CDx will expand access to treatment options for more patients living with solid tumors.
See full press release in Japanese: guardanthealthjapan.com/20251003_01/
Visit us at guardanthealthamea.com/resources/ to find out more about our comprehensive genomic profiling tests which can help guide treatment decisions for patients with cancer. These tests are for prescription use only.
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