Ruifeng Zhou , Peng Yuan , Lihua Zhang , Shuangye Shen , Zhaoliang Li , Yan Wang
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Using digital PCR to detect HER2 amplification in breast and gastric cancer patients
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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