美国食品药品监督管理局（FDA）已正式批准Guardant Health公司旗下液体活检产品Guardant360® Cdx，将其作为Braftovi®（encorafenib）联合疗法用于BRAF V600E突变型转移性结直肠癌（mCRC）患者的伴随诊断工具。
这一批准标志着肿瘤精准医疗领域的重要进展。Guardant360® Cdx作为一种基于血液的检测方法，能够通过简单抽血即可识别出适合接受靶向治疗的患者群体，为传统组织活检提供了一种微创替代方案。
此次获批意味着，临床医生现在可以依据该检测结果，为携带BRAF V600E突变的转移性结直肠癌患者制定包含Braftovi®的个性化联合治疗方案。这种非侵入性诊断工具不仅提升了检测可及性，更有望帮助患者更快获得匹配的靶向药物治疗。
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