近期催化密集:7月Signatera获得欧盟IVDR Class C认证,覆盖多种实体瘤类型,支持欧盟商业化延续至2028年后;同月发表的JAMA Dermatology研究显示Signatera在默克尔细胞癌复发预测中灵敏度达90%,显著优于现有标准。此外,公司6月已获日本PMDA批准、NCCN一类推荐及FDA伴随诊断获批等多项里程碑,机构普遍给予买入评级。
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