SEOUL, South Korea, June 7, 2023 /PRNewswire/ -- Gencurix announced the release of clinical research results comparing the accuracy of its breast cancer prognostic test, GenesWellBCT, with OncotypeDX, the globally top-selling test, confirming its outstanding performance. The study, presented at the American Society of Clinical Oncology, attracted attention from breast cancer researchers worldwide.
This research is a follow-up to a study conducted in 2019 by five South Korean hospitals. While previous studies focused on comparing the concordance, this research aimed to assess and compare prognostic performance through additional follow-up observations. In particular, the analysis evaluated which test accurately distinguished high-risk and low-risk groups based on actual cases, with emphasis on patients under 50, including premenopausal individuals frequently observed in Asian countries.
The study, conducted on a cohort of 759 patients underwent follow-up observations, utilized Recurrence-Free Survival as primary evaluation variable. The results revealed GenesWellBCT demonstrated a superior prognostic performance in accurately distinguishing high-risk and low-risk groups, with a Hazard Ratio of 2.469 for high-risk recurrence compared to 2.093 for OncotypeDX. This difference in favor of GenesWellBCT was more pronounced in subgroup analyses based on lymph node metastasis. GenesWellBCT exhibited excellent prognostic performance regardless of lymph node involvement, while OncotypeDX did not show meaningful results.
Further detailed analysis focusing on low-risk patients by OncotypeDX also confirmed the performance of GenesWellBCT. Among patients classified as low-risk by OncotypeDX, GenesWellBCT identified a subset of high-risk patients had a higher risk of recurrence.
The NCCN guidelines recommend additional therapy, including chemotherapy, for some risk ranges (16-25 points) even for patients classified as low-risk by OncotypeDX in the case of patients under the age of 50. In contrast, GenesWellBCT has demonstrated its clinical effectiveness in predicting prognosis, including for patients under the age of 50.
In Korea, GenesWellBCT is already being adopted by numerous hospitals as a replacement for existing tests. In April, the clinical results of a 15-year follow-up study in Korea and Japan, conducted in collaboration with Sagara Hospital in Japan and Asan Medical Center, were also announced at GBCC 2023.
The promising findings from the comparative study have further solidified the position of GenesWellBCT as an advanced breast cancer prognostic test with enhanced accuracy, providing healthcare professionals with a reliable tool to make informed treatment decisions.