The hallmarks of cancer conceptualization is a heuristic tool for distilling the vast complexity of cancer phenotypes and genotypes into a provisional set of underly- ing principles. As knowledge of cancer mechanisms has progressed, other facets of the disease have emerged as potential refinements. Herein, the prospect is raised that phenotypic plasticity and dis- rupted differentiation is a discrete hallmark capability, and that nonmutational epigenetic reprogram- ming and polymorphic microbiomes both constitute distinctive enabling characteristics that facilitate the acquisition of hallmark capabilities. Additionally, senescent cells, of varying origins, may be added to the roster of functionally important cell types in the tumor microenvironment.

为提高医疗器械技术审评的规范性和科学性，指导医疗器械注册人/备案人编写产品技术要求，根据《医疗器械监督管理条例》及《医疗器械注册与备案管理办法》《体外诊断试剂注册与备案管理办法》的规定，国家药品监督管理局组织修订了《医疗器械产品技术要求编写指导原则》，现予发布。

​9月27日，国家药监局发布《体外诊断试剂临床试验技术指导原则》（以下简称新版指导原则）。新版指导原则历时两年修改，伴随新修订《医疗器械监督管理条例》的实施落地执行，标志着体外诊断试剂临床试验改革进入深入实施阶段。

肿瘤液体活检的检测靶标主要包括循环肿瘤DNA(ctDNA)、循环肿瘤细胞(CTC)和外泌体等。尽管近年来ctDNA的研究取得了较大进展，但其作为肿瘤标志物在临床应用中仍存在许多技术问题。本文简单介绍了ctDNA的生物学特性及相关检测面临的挑战，并概述了相关检测试剂的审评思考。