Guardant Health多癌检测技术获FDA审查 纳入NCI大型癌症研究项目

华尔街洞察
Jul 15, 2025

美国精准肿瘤学领域领军企业Guardant Health Inc.宣布,其多癌种早期检测(MCD)技术Shield已启动美国国家癌症研究所(NCI)先锋研究的患者招募。该技术目前正接受美国食品药品监督管理局(FDA)审查,作为NCI试验器械豁免(IDE)计划的重要组成部分。

这项具有里程碑意义的癌症检测研究计划招募24,000名参与者,旨在评估多癌检测技术在后续临床试验中的应用可行性。由癌症筛查研究网络主导的先锋研究,将重点验证此类检测技术对早期癌症发现的效能,及其在降低癌症死亡率方面的临床价值。

研究采用的前瞻性队列设计将系统评估多癌检测技术对结直肠癌、胰腺癌等致命性癌症的筛查效果。通过血液样本分析循环肿瘤DNA(ctDNA)的表观遗传特征,Shield技术可同时筛查多种癌症类型,为癌症早筛领域带来突破性进展。

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