日本批准为定向治疗检测乳腺癌突变进行第一次血液测试。 Japan approves first blood test to detect breast cancer mutations for targeted therapy.

护卫健康日本已获得日本卫生健康部的批准,使用其 Guardant360 CDx液体活检测作为伴随诊断,用于检测激素受体阳性,HER2-阴性晚期乳腺癌患者的ESR1突变,该癌症在内分泌治疗后已经进展. Guardant Health Japan has received approval from Japan’s MHLW for its Guardant360 CDx liquid biopsy test as a companion diagnostic to detect ESR1 mutations in patients with hormone receptor-positive, HER2-negative advanced breast cancer that has progressed after endocrine therapy. 2025年10月23日批准,这是日本为此目的批准的第一项基于血液的测试,使非侵入性基因组特征分析能够指导无能治疗。 Approved on October 23, 2025, it is the first blood-based test approved in Japan for this purpose, enabling non-invasive genomic profiling to guide treatment with imlunestrant. 测试发现,20%至40%的病人在接受过前期治疗后发现,与抗芳虫酶抑制剂有关的突变与抗药性有关,目前日本指定癌症基因组医院的国家健康保险覆盖了这些突变。 The test identifies mutations linked to resistance against aromatase inhibitors, found in 20% to 40% of patients after prior therapy, and is now covered under Japan’s national health insurance at designated cancer genome hospitals.