几十年来，药物治疗一直受到患者显着差异的阻碍，并且无法预测个体患者水平的结果对其价值产生了负面影响。然而，分子医学的进步使人们对药物的病理生理学和作用机制有了更多的了解，从而能够开发预测性生物标志物。伴随诊断 (CDx) 属于预测生物标志物组，美国食品和药物管理局 (FDA) 将其定义为一种体外诊断设备，可提供安全有效使用相应治疗产品所必需的信息。 25 年前的 2023 年 9 月，FDA 批准了第一个 CDx 检测 HercepTest，这是一种用于检测 HER2 蛋白表达的免疫组织化学 (IHC) 检测。该测定与单克隆抗体曲妥珠单抗在 HER2 阳性乳腺癌治疗中的使用有关。 HercepTest 并不是唯一开发的 CDx。目前，FDA 已批准了 60 多种药物或药物组合（主要是血液学和肿瘤学领域），并对其使用进行了 CDx 检测。本文简要讨论了伴随诊断的主题，并概述了其过去 25 年的演变，特别强调了美国。

For decades, pharmacotherapy has been hampered by significant patient variability, and the inability to predict outcomes at the individual patient level has negatively affected its value. However, progress in molecular medicine has led to an increased understanding of the pathophysiology and mechanisms of action of drugs, thereby enabling the development of predictive biomarkers. Companion diagnostics (CDx) belongs to the group of predictive biomarkers, which the Food and Drug Administration (FDA) defines as an in vitro diagnostic device that provides information that is essential for the safe and effective use of a corresponding therapeutic product. In September 2023, 25 years ago, the FDA approved the first CDx assay, the HercepTest, an immunohistochemical (IHC) assay for the detection of HER2 protein expression. This assay is linked to the use of the monoclonal antibody trastuzumab in the treatment of HER2 positive breast cancer. The HercepTest is not the only CDx developed. Currently, more than 60 drugs or drug combinations, primarily in hematology and oncology, have been approved by the FDA, with CDx assays linked to their use. The current article briefly discusses the subject of CDx and provides an overview of its evolution over the past 25 years, with particular emphasis on the United States.