The GenesWell™BCT is intended for application to early breast cancer patients who are hormone receptor positive (ER/PR+) and human epidermal growth factor receptor negative (HER2-) with metastasis involving fewer than three lymph nodes (pN0/1) and who did not receive preoperative chemotherapy. We identified nine genes which play an important role in the outbreak of breast cancer, and selected the optimal combination of genes to diagnose early breast cancer patients.
Real-time RT–PCR-based GenesWell™ BCT is able to derive the BCT score by substituting the results of each gene analysis into the existing clinical validated algorithms. The BCT Score is used to predict the ten-year risk of metastasis of early breast cancer, and it is used to classify patients into a low-risk group if lower than 4 points and a high-risk group if higher than or equal to 4.
This can contribute to improving the quality of life of patients after surgery by providing the basis for an expert decision on the treatment method. The manufacturing process of GenesWell™ BCT is controlled by a thorough quality assurance system certified by the International Organization for Standardization EN, ISO 13485:2012.