Human epidermal growth factor receptor 2 ( HER2 ) is an important prognostic indicator of breast cancer and a major predictor of anti-HER2 treatment options. HER2-positive breast cancer has strong invasiveness, short disease-free survival, and poor response to conventional chemotherapy and endocrine therapy. In addition, due to the widespread spatial and temporal heterogeneity of tumors, only IHC combined with FISH detection of major lesions may affect the treatment decisions of some patients ; some patients with advanced breast cancer whose tissue samples are not available may also miss the opportunity of targeted therapy. Therefore, the correct detection and evaluation of HER2 status is very important for the clinical treatment and prognosis of patients.


Digital PCR detection has the same effect as gold standard detection ( IHC combined with FISH ), which is suitable for the detection of HER2 status in tissue samples of breast cancer patients. In addition, when tissue samples are not available, peripheral blood can be used for digital PCR detection to find possible treatment options for patients and avoid missing treatment opportunities. Digital PCR detection has the advantages of high sensitivity, strong specificity, high precision, and objective automatic interpretation of the results, which greatly solves some of the evaluation problems caused by tumor heterogeneity.
The expert consensus recommends that HER2 gene amplification detection ( digital PCR ) can be used for dynamic monitoring of the efficacy of HER2-positive breast cancer patients with multi-line therapy, and provide a reference for judging whether patients can benefit from targeted therapy. This technique can also be used to detect HER2 gene status in tissues and peripheral blood of patients with advanced multi-line treatment of other cancers and clinical needs for anti-HER2 treatment.
1. Breast cancer patients ;
2.Patients with solid tumors such as gastric cancer, colorectal cancer, endometrial carcinoma, cervical cancer, ovarian cancer, bladder cancer, and cholangiocarcinoma that need to be evaluated for HER2 status.
( 1 ) To guide the selection of HER2 targeted therapy drugs ;
( 2 ) Dynamic monitoring of the efficacy of anti-HER2 treatment.
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