周一，GRAIL公司股价大幅攀升34%，此轮涨势源于美国食品药品监督管理局(FDA)在周四顾问委员会会议前夕发布了一系列文件。这些文件将对FDA是否批准该公司研发的多癌种血液检测产品起到决定性作用。
Galleri检测技术的原理在于捕捉肿瘤脱落至血液中的DNA所携带的化学标记。该检测不仅能提示癌症信号的存在，还能预判癌症所处的器官位置。自2021年起，GRAIL便以处方形式销售此产品，但FDA至今尚未批准任何一款用于筛查多种癌症的检测手段。
在一项囊括逾2.5万名美国成年人的研究中，Galleri对健康人群的误报率为0.15%。然而，该检测对多数癌症病例未能及时发现。无论是上述美国研究，还是在涉及约14.2万人的英国试验中，Galleri仅能捕捉到约三分之一在一年内确诊的癌症病例。在英国试验里，对于最早期的I期癌症，其检出率仅为14%。FDA已就此向顾问专家征询意见，核心问题在于：这些数据是否足以支撑将Galleri定性为"早期检测"工具？
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