In Vitro Diagnostic Industry in China - Molecular Diagnosis Analyzers and Reagents XIX

Breast Cancer Companion Diagnostic Tests

Human epidermal growth factor receptor 2 (HER-2) is an important driver gene and prognostic indicator for breast cancer. It is also a major predictor of anti-HER-2 therapy. The clinical application of the anti-HER-2 drug Trastuzumab has changed the diagnosis and treatment of breast cancer and greatly improved the prognosis for HER-2-positive breast cancer patients. It is an important breakthrough in targeted breast cancer therapy. In recent years, new anti-HER-2 drugs such as Pertuzumab, Lapatinib, Pyrotinib, and Ado-trastuzumab emtansine (T-DM1) have been developed and successfully marketed, achieving good effects in the treatment of HER-2 positive breast cancer and changing clinical practice.

The gold standard for detecting HER-2 amplification is fluorescent in situ hybridization (FISH) and immunohistochemistry (IHC). HER-2 Gene Amplification Kit (Digital PCR Method) (Registration No.: G.X.Z.Z. 20,193,400,770) of Nanjing Questgenomics Biotechnology Co., Ltd. is based on the digital PCR method. Compared with FISH and IHC, digital PCR requires less tissue sampling, and the results are more objective. Moreover, the results of digital PCR are in good conformity with the gold standard.

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