Gencurix, Inc., a molecular diagnostics company, announced the publication of a new study on Frontiers in Oncology comparing GenesWell^(TM) BCT, a prognostic multigene test, with Genomic Health's Oncotype DX in patients with early-stage breast cancer. A key finding from the study is that the overall concordance between the BCT score and RS was moderate but the concordance was low in women aged 50 years or younger or with lymph node-positive breast cancer.

"Most multigene expression prognostic assays are based on postmenopausal women in Western countries, which raises concerns regarding their prognostic or predictive value in Asian, or young breast cancer patients especially in Asian countries where more than half of newly diagnosed patients are under 50," said Youngkee Shin, M.D., Ph.D., Seoul National University and the corresponding author of this article.

In the article, Mi Jeong Kwon et al. compared the risk classification by the two tests in a large sample of 771 Asian breast cancer patients with HR+/HER2- and pN0/1. The results show that in all patients, the overall concordance between the two risk classifications was 71.9%. Especially, overall concordance was higher in the lymph node-negative subgroup (76.6%) than that in the node-positive subgroup (52.6%). Importantly, of patients in the BCT low-risk group, 91.9% were classified as non-high risk according to the RS.

When applying 2018 TAILORx study guideline, more than half of the patients (55.6%) would be advised to receive chemotherapy by Oncotype DX. However, only 31.9% by GenesWell BCT. According to the second analysis of TAILORx study recently presented in ASCO 2019, patients aged 50 years or younger should take into account their clinical-pathological factors in chemotherapy decisions. Based on this new RS ranges, the proportion of patients who would be advised to receive chemotherapy decreased at 39.1% in the group aged 50 years or younger.

"These results reveal the importance of including clinical-pathologic factors in predicting recurrence and deciding on whether to add chemotherapy. From the very beginning of algorithm design for GenesWell BCT, clinical-pathological factors have been taken into account," said Sang-rae Cho, the CEO of Gencurix. "The findings build on prior studies that demonstrated the clinical utility of GenesWell BCT for predicting which women will benefit from adjunctive chemotherapy at diagnosis in all ages."