Using digital PCR to detect HER2 amplification in breast and gastric cancer patients

Ruifeng Zhou , Peng Yuan , Lihua Zhang , Shuangye Shen , Zhaoliang Li , Yan Wang
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引用次数: 4

Abstract

HER2 amplification detection assays are widely used as companion diagnostic tools for Herceptin targeted therapy on Breast and Gastric cancer patients. Current tests approved for clinical use are in general IHC or FISH-based and could only be used on tissue samples. This requires tissue processing to generate FFPE slices and subjective results determination by pathologists. Here we report the development and validation of a digital PCR based assay to be used to determine the status of HER2 amplification in both tissue and plasma samples. Interestingly, we have found that the status of HER2 may change during therapy and disease development, supporting the necessity of a liquid biopsy assay for HER2 amplification.

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应用数字PCR检测乳腺癌和胃癌患者的HER2扩增
HER2扩增检测技术被广泛用作赫赛汀靶向治疗乳腺癌和胃癌患者的辅助诊断工具。目前批准用于临床的测试一般是基于免疫组化或fish,并且只能用于组织样本。这需要对组织进行处理以生成FFPE切片,并由病理学家确定主观结果。在这里,我们报告了一种基于数字PCR的测定方法的开发和验证,该方法用于确定组织和血浆样本中HER2扩增的状态。有趣的是,我们发现HER2的状态可能在治疗和疾病发展过程中发生变化,这支持了液体活检检测HER2扩增的必要性。
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