优于常用检测方法,早期肝癌血检获得FDA突破性医疗器械认定

2019-11-14 佚名 药明康德

日前,Exact Sciences宣布,其检测早期肝细胞癌(HCC)的血液检测,获得FDA授予的突破性医疗器械认定。在有443名患者参与的临床试验中,这一血液检测在诊断早期HCC患者时达到了71%的敏感度,和90%的特异性,优于常用的甲胎蛋白水平检测。这一检测通过追踪血浆中的4种甲基化DNA标记物和两种蛋白质标记物检测HCC的发生。具体的试验数据在美国美国肝脏疾病研究协会(AASLD)年会上公布。

日前,Exact Sciences宣布,其检测早期肝细胞癌(HCC)的血液检测,获得FDA授予的突破性医疗器械认定。在有443名患者参与的临床试验中,这一血液检测在诊断早期HCC患者时达到了71%的敏感度,和90%的特异性,优于常用的甲胎蛋白水平检测。这一检测通过追踪血浆中的4种甲基化DNA标记物和两种蛋白质标记物检测HCC的发生。具体的试验数据在美国美国肝脏疾病研究协会(AASLD)年会上公布。

肝细胞癌(HCC)是最常见的一种原发性肝癌,通常发生于慢性肝病患者,比如由乙肝或丙肝病毒感染引起的肝硬化。HCC的发病率约占肝癌总数的90%,据估计,每年肝癌在美国的新发病例约为42000例,全球的新发病例约为78万例。中国是HCC发病大国,全世界超过一半的HCC病例都在中国。晚期肝癌的五年存活率低于5%。但若能对HCC进行早期筛查和治疗时,存活率提升至40%至70%。

目前对肝硬化患者的检测手段为推荐半年一次的超声检查,单独的甲胎蛋白(AFP)水平检测,或者两项检测同时进行。大约一半晚期HCC患者具有高水平的AFP,这是一种在胎儿早期发育中产生的糖蛋白,也产自肝脏以及各种肿瘤(包括HCC)。但是与晚期疾病相比,这些检测对早期疾病的灵敏度较低。AFP水平受其它因素影响,比如怀孕以及其他肿瘤都有可能造成结果阳性,带来误诊。

甲基化是基因表达的一种调控方式。在肿瘤细胞中,往往会出现与肿瘤快速生长相关基因的去甲基化,以及抑癌基因的甲基化。甲基化的变化往往出现在癌症的早期。因此能在极早期找到癌症的蛛丝马迹。

本次试验有443名参与者,包括135例HCC病例和308例对照。本次试验结果显示,Exact Sciences的检测对早期HCC达到71%的敏感度,对所有阶段的HCC达到80%的敏感度,而常规AFP水平测试,这一数值分别为45%和62%。

Exact Sciences董事长兼首席执行官Kevin Conroy先生说:“全世界有越来越多的HCC高风险人群,而更灵敏,更方便的基于血液的测试可以帮助他们在更早期发现疾病,从而有更好的预后。本次在肝脏会议上发布的数据让Exact Sciences感到鼓舞,这是对当前可用检测手段的一次飞跃。”

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    2019-11-16 Luyuxie_11
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    2019-11-15 14794e5bm67(暂无昵称)

    学习了,不错的话题,非常精彩,受益非浅

    0

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    2019-11-14 留走人康

    肝癌,接下来就要细分了,对于体质好的病人,能否将PD-1类+抗血管新生+放疗等相结合,甚至有必要用TACE进行减负

    0

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