首页 / 新闻 / 桐树基因解读肿瘤精准诊疗黑科技 加速推动液体活检深入临床应用

桐树基因解读肿瘤精准诊疗黑科技 加速推动液体活检深入临床应用

随着医疗技术和人工智能不断发展与创新,中国医疗产业迎来爆发式增长。其中,临床研究机构及医药行业企业针对肿瘤这一人类健康的头号杀手,也探索出了许多高效且安全的诊疗新模式。日前,在第二届肿瘤诊疗黑科技大会上,我国肿瘤液体活检基因科技引领企业上海桐树生物科技有限公司(下称“桐树基因”)“诊心安”ctDNA核心技术检测平台(下称“诊心安”)斩获精准诊断专场一等奖,将进一步推动液体活检技术的商业化应用进程。

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第二届肿瘤诊疗黑科技大会由北京市希思科临床肿瘤学研究基金会(希思科基金会)、良医汇主办。经过前期2轮CSCO顶级专家评选后,包含“诊心安”在内的21项黑科技产品从近100个项目中突围,进入大赛口头报告环节。“诊心安”ctDNA检测技术是其中仅有的两个MRD检测技术之一,也是唯一一个ctDNA Panel。

“当前肿瘤诊断的活检环节,临床中有25%的人无法通过组织活检拿到证据,而可获得组织的75%人群中有20%会发生不良反应。”桐树基因CEO严令华作口头报告时表示,ctDNA作为非常不错的靶标,可更动态、更全程、更精准了解肿瘤。在今年国际肺癌研究协会(IASLC)公布的专家共识中,ctDNA被定义了几个Plasma First场景,即经治患者靶向治疗的疗效评估、MRD检测、耐药机制的检测首选方法是液体活检。

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虽然ctDNA检测是项好技术,但要做好却也有难度。“ctDNA检测就好比池塘钓鱼,ctDNA是在拥有万条鲤鱼的池塘中唯一的一条黑鱼。”严令华说,在“钓”的过程中,样本收集、cfDNA提取、文库制备、测序和数据分析等各个环节还会损失相应的ctDNA,甚至仅在离提、上机测序两个步骤中损失比例就达76%。

带着尽可能减少ctDNA损失的解题思路,桐树基因依托游离总核酸富集技术、Muliseq超低浓度建库技术、靶向基因片段富集技术及分子标签技术4项核心技术壁垒推出“诊心安”ctDNA核心技术检测平台,实现ctDNA精准检测。严令华介绍道,“诊心安”不仅实现了在抽提环节中多回收20%ctDNA,更成为了国内首家可同步检测cfDNA和cfRNA的技术平台,大大提高了检测融合基因比率。此外,该平台建库起始DNA量可低至1ng,检测下限(LOD)低至0.02%也能够稳定检出,远超行业标准。有临床数据显示,“诊心安”与病理诊断金标准–组织检测对比,一致率可达80%,技术水平媲美国际水平。

在综合评判了项目的技术创新性、产业化可行性、团队优势、市场前景与预期目标的可行性多方面,大会评委团最终给予桐树基因专场最高分。中山大学肿瘤防治中心陈功教授在点评时表示 “非常看好ctDNA技术的前景,相信未来ctDNA检测一定会成为监测肿瘤早期复发转移的最主要手段,甚至今天医学领域中的CEA就是5-10年后ctDNA的发展局面。”

为了能用更多临床数据来提高患者获益,桐树基因方面表示,基于“诊心安”检测平台,还计划投入1亿元,全国同步启动三个前瞻性临床研究来进行验证,涵盖肺癌、胃癌、结直肠癌三个大瘤种,以期获得更多临床数据,为未来肿瘤术后患者提供更多指导。严令华表示,“我们基于‘诊心安’还有5款试剂盒正在同步报证阶段,也期望在2023年-2024年,至少有3款试剂盒能拿到国家三类医疗器械证书,从而进一步推动ctDNA技术的商业化应用,为更多肿瘤患者创造更高价值。”

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