Gencruix said Thursday that it has confirmed the efficacy for GenesWell BCT, a breast cancer prognosis diagnostic system, in predicting the therapeutic effect of breast cancer chemotherapy.

GenesWell BCT is a test that predicts recurrence and metastatic risk of early breast cancer patients who are either hormone receptor positive (ER+ and/or PR+) or HER2 negative while having less than three lymph node metastases within a 10 year period.

The Ministry of Food and Drug Safety approved the drug as a class-3 medical device in 2016.

In this study, the company divided the early breast cancer patients into low-risk and high-risk groups according to the results of GenesWell BCT, and further split them into two treatment methods -- hormone monotherapy, and hormone and chemotherapy.

As a result, there was no difference in survival rates between the low-risk group if the patient received either hormone and chemotherapy or hormone treatment alone after an operation.

For the high-risk group, however, the result showed a significant difference between the group receiving additional chemotherapy and the group without chemotherapy.

Therefore, the company concluded that a combination treatment might lower the immunity of the patient and cause severe side effects, the company said.

By using the results of the company’s platform, hospitals would be able to reduce the risk of side effects and the cost of pharmaceuticals associated with unnecessary chemotherapy in patients classified as low risk, it added.

“The results of this study demonstrate the value of GenesWell BCT as an adjunct to the choice of chemotherapy regimens by demonstrating the efficacy of chemotherapy according to risk groups,” said Moon Young-ho, head of Production R&D at Gencurix. “In the future, customized treatment of early breast cancer through GenesWell BCT will not only help to improve the quality of life of breast cancer patients but also help them alleviate some of their financial burdens.”

The results of the study were published in PLOS ONE.

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