Shuwen Biotech Gains CE Mark for Breast Cancer Gene Assay

China-based Shuwen Biotech has gained a CE mark for its quantitative polymerase chain- reaction (qPCR) kit for measuring the expression of a specific gene in breast cancer tissue.

The CercaTest ERBB2 assay identifies the Erb-B2 receptor tyrosine kinase 2 (ERRB2) gene.

The company claims the test is comparable to existing immunohistochemistry tests that focus on the human epidermal growth factor receptor 2 (HER2) breast cancer gene and are used to guide anti-HER2 therapies, such as Organon’s Ontruszant (trastuzumab deruxtecan).

HER2 is the former gene symbol for ERBB2 and it is widely used to describe the protein encoded by the ERBB2 gene.

The ERBB2 assay, which runs on widely available PCR platforms, is distributed by Shuwen’s German subsidiary, Cerca Biotech.