SEOUL, South Korea, Dec. 3, 2018 /PRNewswire/ — Gencurix, the developer of a molecular diagnostic test, GenesWell™ BCT, reported another evidence for the efficacy of the product.
GenesWell™ BCT is a gene expression profiling test that predicts probability of distant metastasis and recurrence rate within 10 years in patients with HER2-negative, lymph node-negative, and hormone receptor-positive(ER+ and/or PR+) early stage breast cancer.
The additional clinical research shows that patients who are identified as high-risk by GenesWell™ BCT had increased survival rate after undergoing chemotherapy; the research has been published in ‘PLOS ONE’, published by the Public Library of Science of the U.S. (Citation: Kwon MJ, Lee SB, Han J, Lee JE, Lee JW, Gong G, et al. (2018) BCT score predicts chemotherapy benefit in Asian patients with hormone receptor-positive, HER2-negative, lymph node-negative breast cancer. PLOS ONE 13(11): e0207155; https://doi.org/10.1371/journal.pone.0207155).
The result of this new study showed that the patients classified as low risk according to the BCT score had good prognosis with only hormone therapy. There was no significant difference in 10 year distant metastasis free survival (DMFS) between patients treated with hormone therapy plus chemotherapy and those treated with hormone therapy alone. However, the high–risk patients treated with hormone therapy plus chemotherapy showed higher 10 year DMFS than those treated with hormone therapy alone.
GenesWell™ BCT has been approved by Ministry of Food and Drug Safety(MFDS) and received a lot of attention when the clinical evidences of 400 Korean breast cancer patients was published in Scientific Reports, a sister journal of the Nature. Currently, they are planning joint clinical study collaborating with hospitals in Japan.
"GenesWell™ BCT is the first products that completed clinical trial with Asian patients, reflecting the genetic and environmental characteristics of Asians." Sangrae Cho, CEO of Gencurix, said in a statement announcing the publication of the study results. "It is of great significance to have objectively proved that the BCT score is not only of prognostic value, but is also a predictor of chemotherapy benefit for early breast cancer," he added.
Gencurix has been selected as one of Hi Seoul Brand Company in 2017. Recently, GenesWell™ ddEGFR Mutation Test, the test that detects EGFR mutation for non-small cell lung cancer, has been approved by MFDS. It is about to hit the Asian market including Japan.